REGISTRATION

2724-811 
DATA PACKAGE BEAN SHEET 

Date: 20..Jul~2011 

Page 1 of3 

* * * Registration Information * * * 

Registration: ~I~4_-Jt~_L~-'3,r:~J~_4_~~9M~Q_ 

Company: 2724· WELLMARK INTERNATIONAL 

Risk Manager: '3~ __ !~ __ ~ __ ~~E~_~~~E\O!_~_~_ V9_~t~9_~_~_9_1_ 2~ __ ~_!)_!)!"'l1# __ P'{_1 __ :5_~?2_~_~ __ _ 

Risk Manager Reviewer: 15_e:~!_~ __ §~~~_~~_'f_I<:_:3:~_§_§~_~_Y ___ _ 

Sent Dale: Calcula1ed Due Dale: 12-Nov-2011 

Decision #: 450780 

DP #: (392062) 

PRIA 

Parent DP #: 

Submission #: 898013 

E-Sub #: 

Edfled Due Date: 

Action Desc: {R~~.o: 9t !':J?_f\!~~_~~T:T~91<: __ (I_~_Q~!:J_!?:_~_~_g_tl~_f'.I_~_~§_}9_f'_'3_§g_p._~::r_19_f'.I_~_'3_), ___ ~_~_§~ __ ~::rA::r§_f\/ 

Ingredients: ~~~P~fl~ __ ~ ___________________________________________________________________________________________________________________________________________ _ 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Date Sent: 20·Jul-2011 Due Back: 

DP Ingredient: _~_~_r:_p-'.~_~~_~ ______________________________________________ _ 

DPTitle: 

CSF Included: 0 Yes. No Label Included: • Yes 0 No Parerrl DP #: 

Date In Da1e Ot.r1 

Organization: RD I TRB Last Possible Science Due Date: 13-0ct-2011 

Team Name: TOX Science Due Date: 

Reviewer Name: Sub Data Package Due Date: 

Contractor Name: 

* * * Studies Sent for Review * * * 

Printed on Page 2 

* * * Additional Data Package for this Decision * * * 

No Additional Data Packages 

* * * Data Package Instructions * * * 

Byronb, 

Please find attached a label amendement for addtion of puppies to the label. 2724-796 and 2724-811 are relyiong on the same data. 

Kevin 

305-5063 

1
Page 2 

OP#: (392062) ~ * * Studies Sent for Review * * * Oecision#: (450780) 

~~ 

2
Page 3 

DP#: (392062) * * * Product ... A Data Package Ingredients * * * Decision#: (450780) 

/067501 ~1'{)3-6 IPiperonyl butoxide(5%) 

1128965 ~0844-07-1 jEthofenprox(30%) 

3
-

ISB'S Front-end PRlA Completeness Screen 

Draft 3; 10/25107 

-

'ecipl Date: NOV 2 3 Z010 EPA Reg. Number: ,J,7J.if - IRi2, 

Check List Item -" - -- -

-

II 

I' 

as the PRIA Fcc been Paid; is a copy of the check or 

ay.gov receipt included in the Submission Package? .. -

Is 'all APllliciltiOIl Form (EPA FOln18570~I) Included in the 

:~ s 

II 

uhmiss'ioll Package, is it completely filled out and signed 

lcluding package type? 

-_._._-

Is 'a ConHdcutial Statement of Formula (EPA Fom1 8570~ 

3 2 9) Included in the Submission Package, is it completely 

,I 

(, 

7 

Ii lied Dut and signed (boxes 1~21)? 

.-.~-

· a Formulator's Exemption Statement (EPA Fonn 8570~ 

7) Included in the Submission Package? 

Is 

2 

--... _--_.-

Is , 11 C'crtiricntioll with I~cspcct to Citation of Data (EPA 

I orn] i)S70<M) Included in the Submission Package? -- ----_. -"_.-

Is ·H nuln Mntrix (EPA Form 8570-35) Included in the 

S uhmlsslon Package? -,---.~. 

Is · H Lahcllncluded io thc Submission Package'! 

re Data Included In thc Submission Package? --- I) Is · tbe Submission all Amendment? 

Yes No NIA 

{ 

;I 

X 

< 

X ----

X 

X 

X 

4
l)i\ITED 5T:\TI:S I:NVIRON\,[I,NTA!, I'ROTEC'TIC)N !\Gf),;C'Y 

WASIII:\ClU~. D.C. 20·160 

Ms. Nancy Huebl 

Senior Registrations Specialist 

Wellmark International 

1501 East Woodfield Road, Suite 200 West 

Schaumburg, IL 60173 

Subject: Label Amendment (R300) 

RF2164-AlT Combo 

EPA Reg. No. 2724-811 

Submission dated August 25, 2011 

Dear Ms. Ruebl, 

OCT - 6 1011 

The amendment referred to above, submitted in connection with registration 

under the Federal Insecticide, Fungicide and Rodenticide Act, is acceptable. 

A stamped copy of your label is enclosed for your record. If you have any 

questions, please cal! Kevin Sweeney at (703) 305-5063. 

Enclosure 

Sincgely, ~~ 

~~ ) 

·c ard ken 

i~ Prod et ager 10 

Registration Division (7505P) 

Insecticides Branch 

OFFICE OF 

ClH'MIC .. \1 SAI'l'TY.'\ND 

1'01 ,LUTION I'RI,\TN ['l()K 

5
RF2164 AfT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Pane! ~ For Use Only on Toy (6~12 !bs.), Small (13~31 !bs.), Medium (32~55 !bs.), Large (56 -80 

Ibs.), and Extra Large (81 Ibs. and over) Dogs 

Front Panel- For Use Only on Dogs 6 months of age or older 

[Flea & Tick [& MosquitoJ[Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs 

General Claims: 

5 size categories provide [smaller] weight ranges to improve [maintain][deliver] efficacy 

[periormance][f/ea and tick][control][protection] on [for] your dog 

Effective on indoor and outdoor dogs 

([1J[3J[4([6J monthly treatments) [1J[3J[4][6J Months Supply [24J[48J doses 

Spreads naturally with dog's movement (skin and hair oils) 

[Formula][Contains lanolin for coat conditioning] 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

[Fast Acting][Long Lasting]Kills Fleas and Ticks by Contact] 

[F res h J(Glean JJJ ScentJ (SmellJ 

[Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

Efficacy Claims: 

Each tube [cartridge][vial] ]application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month]] Four/4 Week ]Flea][Tick]{Mosquito] Treatment] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hours][Kilis more than 5Q% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to [75 days][2.5 months]] 

[Breaks Flea Life Cycle for [more than 10 weeks] up to [75 days]{2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to {75 days]{2.5 months] 

[With {S-Methoprene] Insect Growth RegUlator [IGR] to Break Flea Life Cycle] 

ACCEPTED 

OCT - 6 " 

Under the Federallnsect1cl:de, 

FungIcide, and RodenUctdeAct, as amended, fOI" the pe&tlctde 

Registered under 

EPA Re;<. No. .. 'l: II 

1 

6
Applicator Claims 

[New] [applicator] 

[New] contemporary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [liquid][application] get down to [the][your][dog's] skin 

Ergonomically contoured [ergonomic][shape][design] for easy handling [ease of use] [easy use] 

For use with [only][brand name][disposable][liquid dispensing] tubes [vials] [cartridges] 

[brand name] [applicator][has][provides]]allows for][delivers] better grip 

[brand name][provides] re-closable [re-sealable] packaging for [easy] storage 

Closing [the][brand namej[applicator] door automatically opens the [disposable]]liquid dispensing] tube 

[vial][cartridge] 

[brand name] [Applicator]]will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the [your] dog 

Includes unique [brand] applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator]]DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New ]disposable][Jiquid dispensing] tube [cartridge][vial] 

[New] [brand name][disposable]Uiquid dispensing]]tube][vial] tip [helps][to] spread out liquid [on your]]dog] 

Unique [cartridge]]tube][vial] with flow control 

[no drip][no mess][application][tube][cartridge][vial] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator][tube][vial[cartridge]][inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

[brand] Refill Pack [brand][applicator [device] not included] 

Refill Claims 

For use ]only] with [brand name][Applicator] 

[[1][3][4[[6] monthly treatments) [1][3][4][6] Months Supply [24][48] doses 

Easy to use [convenient] refills 

[Can be used with] [Use with] [Brand Name] applicator 

[Brand Name] Applicator [Refills][Refili Pack] 

Refill Pack [for][Brand Name] Applicator 

RefillS [Refill Pack] available 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

7
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1 ) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

~(butyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fI oz (1.5 cc) [vial][tubellcartridge] (Toy Dogs)/ 

0.10 fI OZ (3.0 cc] [viall [tube][cartridge] (Small Dogs)! 

0.15 fI oz (4.5 cc)[vial][tubellcartridge] (Medium Dogs)/ 

0.20 fI oz (6.0 cc) [vial][tube][cartridge] (Large Dogs) 

0.30 fI oz (9.0 cc) [vial][tube][cartridge] (Extra Large Dogs) 

[ICON - DO NOT USE ON CATS] 

3 

8
SUBLABEL A - APPLICATOR DEVICE PACKAGE 

1. DIRECTIONS FOR USE WITH APPLICATOR 

RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AfT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kins and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kins and repels 

mosquitoes. 

A unique, convenient applicator for you. The new [brand] Applicator is specially designed to make 

applying flea and tick control easier, more precise -- and neater- than ever before. You simply insert 

the appropriate [brand] tube [vial][cartridge] for your dog into the applicator, close it and squeeze to 

apply. The applicator's ergonomic, contoured shape [design] makes it easy to grip and a built-in fin 

[tip] [comb] helps to spread [part] the [your] dog's hairto allow the liquid to more readily [better] reach 

[apply] the [to] [your dog's] skin. The tube [vial][cartridge] is sealed inside, so you can be confident 

that the liquid goes onto your dog - and not your hand. Plus, if the applicator is laid down on a table, 

counter or other flat surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. [If you choose to apply directly to dog without using the applicator device, read and 

follow the Directions for Use For Direct Application to Dog on this package.] 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. 00 not retreat more than once per 

month. 

RF2164 NT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to'(ha' 

skin. 00 not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube]vial][cartridge] per dog per applic&tion~] 

The RF2164 AIT COMBO provides a unique applicator device that allows dog owners to freat 

their dogs more securely, and dispose of liquid cartridges [tubesj[vials]with less me3s. 

4 

9
[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications] 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minor differences 

relate to device features. Potential icon designs are on the last pages of this document. 

Text appearing on icon pages is for illustrative purposes only and does not represent 

full text as indicated in DFU which will appear on labeL] 

[DFU Set No.1] 

FOR [TOy][SMALLJ[MEDIUM] SIZE DOGS 

To apply the [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicator device, ensuring that the 

cartridge [vial][tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid] cartridge 

[vial][tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 AfT COMBO evenly to [two 

spots](toy dogs)[three spots[(small dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][butlon][thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 AfT COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side [buttons together] to open 

applicator device door and discard empty cartridge [tube][vial] into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in original package.] 

6. USE RESTRICTIONS: Do not reapply product for 30 days unless re-treatment is required, 

but not sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

5 

10
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 The dog should be standing for easy application. Apply RF2164 AIT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

down on the round [circle][button][thumb pad] to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. Do not spread RF2164 NT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

5 

6 

[DFU Set No.2] 

FOR [TOy][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge ]tube][vlal] 

Ifor each application] with the applicator device. 

1. OPEN [Icon] 

With [color] door facing downward, push side [buttons] to open applicator. 

2. LOAD ]Icon] (3 alternate statements) 

-[To Load, insert tube [cartridge][vial] [color side down][white side up]. Press down on tube 

[cartrldge][vlal][ until [two [color]] tabs click In place]. 

-[To Load, place tube[cartrldge][vlal]under the [color, e.g. green] tabs] [In the applicator] 

-[To Load, place tube[cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [Icon] 

Point tip up and close the [color, e.g. green] door. The tube [cartridge][vial] will snap open and is now 

ready to apply. 

4. APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on [color] door] [Press round thumb pad] once at each of [two] (Toy dogs) [three] 

(Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the tail. Do 

not apply an excessive amount of the solution at anyone spot that could cause some of the solution 

to run off the side of the dog. Do not spread RF2164 AIT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into tra'iS, 0:-<Jffer for recycling if 

available. [Close applicator device door and store in original package.] , 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not SODnw ~han 8 C:c.y& 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

6 

11
FOR [LARGE][EXTRA LARGE] OOGS 

1 

2 

3 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on [color] door][Press round thumb pad] once at each of four or five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 

6 ." 

[DFU Set No.3] 

FOR [TOY][SMALL][MEDIUM]DOGS 

To apply the [RF2164 AIT COMBO] treatment, use one disposable liquid cartridge ]tubellvia~ 

[for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]under the [color, e.g. green] tabs lIin the applicator] 

-[To Load, place tube [cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on [color] door once at each of [two] (Toy dogs) [three] (Small 

Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that could cause some of the solution to run off 

the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

To dispose of empty tube, open [color, e.g. green] door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not socr:er tr.an 8 days' 

after the initial treatment. Do not retreat more than once per month. ' 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] application::;J 

7 

12
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 __ _ 3 __ _ 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on [color] door once at each of four or five evenly placed 

spots between the shoulder to the base of the tail. Do not apply an excessive amount of the solution 

at anyone spot that could cause some of the solution to run off the side of the dog. Do not spread 

RF2164 AfT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally 

distribute the application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

5 6 __ _ 

RF2164 NT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AlT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AIT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

[TREATMENT SCHEDULE 

Dosaoe: 1 rcartrldoelltubellvlai] every 30 days er doq 

Pet's Name First Treatment Date se~ond Treatment ~)ate 

30 Davs From 151 

Reminder. I purchased RF2164 AJT COMBO from. ~~~~~~~_ 

NOTES: 

TreatmeC"nt:-:t"abul"e-:c"an::Cb"e-:e"xp:Ca"n::;ded based on package size. (6 months)) 

T(~ird Treatment Date 

30 Davs From 2nd) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse cartridge [vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: CalJ your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD_ For external use only_ Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Re;;eG:.ted 

exposure to etofenprox can cause skin irritation. Consult a veterinarian befolE. \15;1 rg this 'Product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities 1 nay o(:cur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet w:t~ rT.i!j SOCii=) a:1d rinse 

with large amounts of water. If signs continue, consult a veterinarian immediatb[VSome pets may experience hair loss or temporary skin irritation at the applicG't;C'r site. It G~;r.s persist 

or become more severe, contact veterinarian immediately and report incident tc co;npany at 

1-800-XXX-XXXX. 

8 

13
FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the pruduct container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBE/CARTRIDGEIVIAL 

Product name 

Etofenprox 30%, (S )-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12Ibs.), Small (13-31 Ibs.), Medium (32~55Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

9 

14
Alternate Sets of ICONS for the RF2164 AIT COMBO 

[ICON SET 1] 

[OPEN] 

[LOAD] 

~ ~ 

[CLOSE] 

[APPLY] 

[DISPOSE] 

10 

15
[ICON SET 21 ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

green dOC< facing 

Push two side buttons 

to OPEN 

To LOAD Place lubewi!h 

"',",'TI' UP mID aPl',icalDr 

Click tube llf1d€< 

Close the green dOC< and 

the tube will snap open. 

To APPLY Use Tip ID part fur 

and get next to dog's skirL 

. Pfe'"'...s circle on green door 

once at each of ~ spo-s 

bet'Neen shoulders 

and tail 

DISPOSE of empt; tube 

t'oNo side buttDns to 

dOC< and 

--__ ,![ltD trash 

{"#Spots" is a variable dependent on size} 

Door color may change based on brand. 

(Alternate LOAD icon) 

To LOAD place tube WHITE 00e UP 

~erthe gre-:ntabs 

CLOSE the green door 

and the tube will snap open. 

11 

16
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

Use l!!1ger scoop to HIt OPEN door 

To APPLY Use TlPbpartrur 

and get next ro dog's skill 

'. C"=~ circ~ on green door 

once at ead1 of #1 spots 

between shoulders 

and tall 

("#Spots" is a variable dependent on size) 

Door color may change based on brand. 

12 

17
[2. DIRECTIONS FOR USE FOR DIRECT APPLICATION TO DOG 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 AlT COMBO works by applicalion direclly 10 Ihe dog's skin, nollo Ihe hair. When 

applying, manually push aside dog's hair to allow direct application to the skin. Do not get this 

product in dog's eyes or mouth. 

[(Note: Application now assumes one applicator per animal per application)] 

[Note: Each package contains sufficient tubes/applicators for [Xl applications] 

FOR [TOY][SMALL][MEDlUM] SIZE DOGS 

1. Bend at perforation and tear off first applicator [tube]. [ 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] Hold 

applicator [tube] upright and snap tip back, away from face and body. 

3. The dog should be slanding for easy applicalion. Apply RF2164 AIT COMBO evenly 10 

[two spots](loy dogs)[lhree spols](small or medium dogs) on the lop of Ihe back from Ihe 

shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place 

the tip of the tube on the skin and gently squeeze to expel a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. 

4. Do nol spread RF2164 AlT COMBO by hand over Ihe dog. Allhough Ihe dog's skin and 

hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 

hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator] as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 

days after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient tubes/applicators for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1. Bend at perforation and tear off first applicator [tube]. 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] 

Hold applicator [tube] upright and snap tip back, away from face and body 

3. The dog should be slanding for easy applicalion. Apply RF2164 AIT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At 

each spot, part the hair until the skin is visible. Place the tip of the tube on the skin and 

gently squeeze to expel a portion of the solution on the skin. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution 

to run off the side of the dog. 

4. Do nol spread RF2164 AlT COMBO by hand over Ihe dog. Allhough Ihe dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator] as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment. Do not retreat more than once per mO!"'!th. 

RF2164 NT COMBO is most effective when used as part of a total flea and tick managerr.ent 

program. Use other [Brand Name] products registered for residential area control -.Jf thes-3 

pests in conjunction with this treatment. Monthly treatments are required for optilrlal controi 

and prevention of fleas. 

13 

18
(The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD), Treatment of dogs with RF2164 AIT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AfT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

[TREATMENT SCHEDULE 

Dosaoe: 1 [cartridoel [tubeJlvial] every 30 days er do!=) 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 1") (30 Days From 2"d) 

Reminder: I purchased RF2164 AfT COMBO from: 

NOTES,======:::o 

Treatment table can be expanded based on package size. (6 months)]] 

14 

19
SUB-LABEL B FOR REFILLPACKAGE 

(For use with applicator device or direct application to dog without applicator 

device) 

(Front Panel) 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot~On Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Me1hoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

1butyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and) Additional Precautionary Statements 

EPA Reg. No. 2724-811 

EPA Est No. 

NET CONTENTS: One: 0.05 fI oz (1.5 ee) (viailltube](cartridge] (Toy Oogs)/ 

0.10 fl OZ (3.0 eel (viailltubellcartrldge] (Small Oogs)/ 

0.15 fI oz (4.5 ee) ]viailltubellcartridge] (Medium Dogs)! 

0.20 fI oz (6.0 ee) (viailltubellcartridge] (Large Dogs) 

0.30 fI oz (9.0 eel (viailltubellcartridge] (Extra Large Dogs) 

[ICON - DO NOT USE ON CATS] 

15 

20
(Sack Panel) 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AfT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

[Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes.] 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

[To apply the RF2164 AfT COMBO treatment with the [Brand Name] applicator. use one 

disposable liquid cartridge [tube][vial][for each application] with the applicator device.] 

[Remove one refill tube [cartridge][vial] from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device.] If you need directions for application, please call1-800-XXX-XXXX. 

[However, if you choose to apply directly to dog without using the applicator device, read and 

follow the Directions for Use For Direct Application to Dog on this package.] 

(DIRECTIONS FOR USE FOR DIRECT APPLICATION TO DOG) 

[USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 NT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, manually push aside dog's hair to allow direct application to the skin. Do not get this 

product in dog's eyes or mouth. 

16 

21
[(Note: Application now assumes one applicator per animal per application)] 

[Note: Each package contains sufficient tubes/applicators for [Xl applications] 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS 

1. Bend at perforation and tear off first applicator [tube]. [ 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] 

Hold applicator [tube] upright and snap tip back, away from face and body. 

3. The dog should be standing for easy application. Apply RF2164 AlT COMBO evenly 

to [two spots](toy dogs)[three spots](smali or medium dogs) on the top of the back from 

the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. 

Place the tip of the tube on the skin and gently squeeze to expel a portion of the 

solution on the skin. Do not apply an excessive amount of the solution at anyone spot 

that could cause some of the solution to run off the side of the dog. 

4. Do not spread RF2164 AJT COMBO by hand over the dog. Although the dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator] as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient tubes/applicators for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1. Bend at perforation and tear off first applicator [tube]. 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] 

Hold applicator [tube] upright and snap tip back, away from face and body 

3. The dog should be standing for easy application. Apply RF2164 AJT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At 

each spot, part the hair until the skin is visible. Place the tip of the tube on the skin and 

gently squeeze to expel a portion of the solution on the skin. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution 

to run off the side of the dog. 

4. Do not spread RF2164 AJT COMBO by hand over the dog. Although the dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator] as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment. Do not retreat more than once per month. 

RF2164 AJT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AfT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AfT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

17 

22
[TREATMENT SCHEDULE 

Dosaae: 1 rcartridael ftubelrvian everY 30 days er dog. 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 1") (30 Days From 2"d) 

Reminder: I purchased RF2164 NT COMBO from: 

NDTES:.-,-,--cc_---,-___ , 

Treatment table can be expanded based on package size. {6 months}]] 

(Precautionary/First Aid and Storage/Disposal) text included} 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

WeUmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

18 

23
Wellmark 

August 25, 2011 

Wellmcuk Intei .onell 

1501 Eosl Woodfield Rood, SUI Ie 200 Wesl 

Schoumbu'9, illinois 60173 

8473305300 

wwwwelhmkinte.nolionol com 

Document Processing Desk (AMEND) 

Office of Pesticide Programs 7504P 

U.S. Environmental Protection Agency 

Room S~4900 One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202~4501 

ATTENTION: Richard Gebken, PM13 

SUBJECT: LABEL AMENDMENT TO ADD DIRECTIONS FOR USE 

FOR APPLICATION DIRECTLY ON DOGS WITHOUT APPLICATOR DEVICE USE 

FOR RF2164 NT COMBO/EPA REG. NO. 2724-811 

Dear Mr. Gebken: 

Enclosed is a completed EPA Form 8570~ 1 and 5 copies of amended labeling for the above product. One 

highlighted copy has a cover sheet detailing the changes. New text is highlighted in red, deleted text is 

marked as strikethrough. The change involves adding directions for use (which match the approved DFU 

from the similar formulation 2724~796) to the applicator device and refill sublabe!s. This will give users the 

option to apply the product directly onto the dog without using the applicator device if they choose. There 

is no change in the application rate, the dosage, timing, frequency or exposure resulting from use with thE; 

alternate Directions for Use. Because these Directions for Use have previously been approved under the 

2724~796 EPA registration, we request an expedited review/approval of this label. 

If you have any questions or if I can provide any further assistance, please, call me directly at 847~330~ 

5376. 

Yours sincerely, 

Nancy Huebl 

Senior Registration Specialist 

nhuebl@central.com 

enclosure 

24
" ease ra ad/ tmcti "' ons on reverse ", , recom pf e ti ng ~ orm F oem A pproy~ ... OMS N o. 2070 . 0060 A pprova expires 228 . . !l5 

Re,. .ration OPP Identifier Number 

,.,. Um,,,,, States 

X '"', EPA Environmental Protection Agency Amendment 

Washington, DC 20460 ..:;.. 

Other 

A lication for Pesticide· Section I 

t. Company/Product Numt>er 2. EPA Product Manager 3. Proposed Ciassificatioo 

Wellmark InlemalionaI/2724-811 Richard Gebken 

4. Company/Product (Name) 'M' E:] Nooe o Restricted 

Wellmark Iniernational/RF2164 AIT Combo 13 

--------------------- ------------------- -- ---- --- -- ----- --------------------- -------------

5. Name and Address 01 Applicant / Registrant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Seclion 3(C}(3} 

Wellmark Inlernalional (b)(i), my producl is similar or idenlicalin composilion and labeling 10: 

1501 East Woodfield Road, Suile 200W EPA Reg. No 

Schaumburg, Illinois 60173 

Producl Name 

n Check if this is e new address 

Section· II 

G Amendment - Explain below. o Final printed labels in response to 

Agency letter dated D Resubmission in response to Agency letter dated -- ---------------------------------

o "Me Too" Application 

o Notification - Explain below. o Other - Explain below. 

. .. --... 

Explanalion: U$e additioll8t page(s) it neces5a'Y. (For $OC\ion t and section tt) 

Label amendmenllo include directions for use for applicalion direclly on dog wilhoul using applicalor device 10 bolh sublabels (Applicalor device package 

and refill package) 

Section· III 

1. Material ThiS Product Will be Packaged In: -- Child·Resistant Packaging Unit Packaging Water SOluble Packaging 2. Type ot Container 

t]y" @y", @y", No X No ~M'''' X Plastic 

X No Glass ---------.--

It "Yes Unit No. per It "Yes Unit No. per X Paper 

* Certification must be Packaging wgt. cootainer Packaging wgt. container Other (Specify) 

submitted 0.05 - 0.30 fl oz 1 - 12 ---"- ----------------------------

3. Location ot Net Contents Information 4. Size(s) Retail Container 5. Location of Label Directions 

[3] Label [3] Container 0.05 - 0.30 fl oz (1.5 - 9 cc) lubes E9 On Label 

------------ ,..... ------------------- --------- ------------------------G~~~; 

____ ~_~~~el_~:x>_ITIP~!1~_n\J __ ~rclduct _ 

6. Manner in Which Label is Affixed to Product r= Uthograph printed on cardboard 

Paper glued 

Stenciled 

Section - IV 

1. Contact Point {Complete i.tfi'!'s dirlJC.tly be/ow foride'!_~if!£_<!_tJ'?'! __ of IndIYfdua/ to be <:CltlJ<lc!e9,J~_(1€lc.essary, topr(jC£S_S _this apfI/i(;_a_t!.CI_,!'} __ ------------------------------

Name Title Telephooe No. (Include Area Code) 

Nancy Huebl Sr. RegislraUon Specialisl 847-330-5376 

---------------------------

Certification 6.Date"ppliLaticn 

I certify that the statements t have made on this lorm and all attachments thereto are true. accurate and complete. I Received 

acknowledge that any knowinglytalse or misleading statements my be punishable by fine or imprisorment or both (Slamped) under applicable law. 

- ------------- ---------_. 

2. Signature c;tiv..d:t 3. Title 

'f" Sf. Registration Specialisl 

....... . !!flUYrf 

4. Typed Name 5. Date 

Nancy Huebl 2S.Aug-11 

EPA Fonn 8570-1 (Rev. 3-141 Prevtou. ocIItlora are oInoIete. White . EPA File Copy (ongmal) Yellow -Applicant copy 

25
[leT - 6 

OCT - 5 2C11 

Tracking 

Create Resubmission 

FFS letters 

Action Cede Hl!Jlory 

Secondary Decision 

OCT - 6 

V lJO 

26
FASY-TRACK r-;J).,fijl\lI:>':MIENTS--COj:npl.~te.n: 

Experts In-Processing Signa~re: 

EPA Reg: Number: 't z 1 

1 Application Form (EPAFonn 8570-1) -signed? 

2 Statement of Formula (EPA Fonn 

.. 1i)~1 

J Screening Ch~cklist 

3 Cel"tifica1ion with Respect to Citation of Data (EPA Fonn 8570-34) 

signed? 

4 Formrilator~s Stateinent (EPA Form 8570·27) -

owns only the 

6 Is Label IncJuded? (5 copies) 

27
28
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

JAMES MCFADDEN, PH.D. 

WELLMARK INTERNATIONAL 

August 31, 2011 

1501 E. WOODFIELD ROAD, SUITE 200 WEST 

SCHAUMBURG, IL 60173 

PRODUCT NAME: RF2164 AJT COMBO 

COMPANY NAME: WELLMARK INTERNATIONAL 

OPP IDENTIFICATION NUMBER: 

EPA FILE SYMBOL: 2724-811 

EPA RECEIPT DATE: 08/30111 

SUBJECT: RECEIPT OF AMENDMENT 

DEAR REGISTRANT: 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

The Office of Pesticide Programs has received your application for an amendment and it 

has passed an administrative screen for completeness. 

During the initial screen we determined that the application appears to qualifY for fast 

track review. The package will now be forwarded to the Product Manager for review to 

determine its acceptability for fast track status. 

If you have any questions, please contact Registration Division, Risk Management Team 

13, at (703) 305-0120. 

Sincerely, 

tt 1hrpu.-

Front End Processing Staff 

Information Services Branch 

Information Technology & Resources Management Division 

29
IFee for Servicel f902417"-

-----, 

o New Registration 

@Amendment 

i DStudies? ~I Fee Waiver? 

for Division 

OAD 

oBPPD 

@RD 

Risk Mgr. 

! 

i [J volpay % Reduction: __ L __ ~ ______ ~_____ _ __________ ~ _. ___________ __ _____________J -------------_·_-------_·_---------------------------------~---------------------------

I Receipt No. s-I 902417 1 

I EPA File Symbol/Reg. No. I 2724-811 1 

I 

---0 

I Pin-Punch Date: 1 8/30/2011 1 L __ . __ . _____ .. ____________ . __ ..1 ------------------------------------ ------------------------~----

. This item is NOT subject to FFS action. ~'f'-/ 

1- -----:t\ctran-CO-de-: 1 • P arentiC h ildDeciSions:l. 

I I 

Requested: 

Granted: 

Amount Due: $ __ _ 

! ----______ 1 '------------------- -~ 

D Uncleared Inert in Product 

Reviewer: __ +iv4-t~\,-A----\-7'~'__\_')-'------ Date: il4/1 

Remarks: 

30
REGULATORY LABEL DATA SHEE", 

File Name: 

Product: 

Approved: 

OVERVIEW: 

RF2164 AfT COMBO 

RF2164 AlT COMBO 

Data Sheet Date: 

EPA Reg #: 

Supercedes: 

August 2011 

2724-811 

319111 

Label amendment to include two sublabels, 1. Applicator device package (use with 

device and also without [direct application to dog1 and 2. Refill package: use with device and also without 

[direct application to dog] 

Page # Description of Major Changes 

2 Marketing claims: added claims for refill packs 

4 Added header to indicate Subia bel A - use with applicator device 

Directions for Use: added optional text to cover direct application reference 

6-8 Directions for Use: added generic "color" to door/tabs descriptor as color may change 

based on brand 

Marked Treatment Schedule table as optional (space issue) 

11-12 Icons: added statement indicating color change based on brand 

13-14 Directions for Use: 2. added directions for use for application directly on dog without 

using applicator device (directions for use are same as DFU already approved for 

2724-796) 

15-18 Refill Package Sublabel - added B to header to differentiate refill sublabel 

Added descriptor to indicate refill tubes can be used with or without device 

Added front panel label required text 

Added back panel label required text 

Added optional marketing text (copied from Sublabel A) 

Added optional Directions for Use for direct application to dog 

(directions for use are same as DFU already approved for 2724-796) 

1 

31
r,.r'2164 AfT COM 80 

(Text for "Dog" must be same size as Brand Name) 

Front Panel- For Use Only on Toy (6-12Ibs.), Small (13-31 Ibs.), Medium (32-55Ibs.), Large (56 -80 

Ibs.), and Extra Large (81 lbs. and over) Dogs 

Front Panel - For Use Only on Dogs 6 months of age or older 

(Flea & Tick (& Mosquito](Treatment] (and] Control) 

Spot-On Flea & Tick Control for Dogs 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724 706, are in blas~ 

5 size categories provide [smaller] weight ranges to improve [maintain][deliver] efficacy 

jperformance][f1ea and tick][control](protectionj on (for] your dog 

Effective on indoor and outdoor dogs 

([1](3](4((6] monthly treatments) (113](4](6] Months Supply (24](48] doses 

Spreads naturally with dog's movement (skin and hair oils) 

[Formula](Contains lanolin for coat conditioning] 

]Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

[Fast Acting](Long Lasting](KiIls Fleas and Ticks by Contact] 

[Fresh 1 Clean ]((Scent ][Smell] 

(Reapply monthly] [Suitable for year-round use](Month] sticker for home calendar 

{Satisfaction guaranteed or your money back] 

] Patent Pending] 

Efficacy Claims: 

Each tube (cartridgej(vial] {application]]kills fleas & ticks for 3 weeks] and (kills and repels mosquitoes for 

3 to 4 weeks] 

]protects for up to (Four/4] Weeks](One month]]Four/4 Week [Flea][fick][Mosquito] Treatment] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

(Kills 85% of ticks within 48 hours][Kills more than 50% of fleas in 2 hours] 

(Dual Action kills adult fleas and prevents flea development] 

] Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm-) 

Monthly application for most effective protection 

IGR Claims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to (75 days](2.5 months]] 

[Breaks Flea Life Cycle for {more than 10 weeks] up to {75 daysll2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to (75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator (IGR] to Break Flea Life Cycle] 

1 

32
Applicator Claims 

[New] [applicator] 

[New] contemporary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [Ilquid][application] get down to [thellyour][dog's] skin 

Ergonomically contoured [ergonomic][shape](design] for easy handling [ease of use]]easy use] 

For use with [only](brand name](disposable][liquid dispensing] tubes (vials] [cartridges] 

[brand name] [applicator](has][provides][aUows for][delivers] better grip 

]brand name][provides] re-closable [re-sealable] packaging for [easy] storage 

Closing (the](brand name][applicator] door automatically opens the ]disposable][liquid dispensing] tube 

(vial][cartridge] 

(brand name] (Applicator] [will not drip after opening] 

[brand name]]Applicator] Won't drip when set down as you go fetch the [your] dog 

Includes unique ]brand] applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot-on (dose] [product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New ]disposable](liquid dispensing] tube [cartridge][vial] 

[New] [brand name][disposable](liquid dispensing] (tube](vial] tip [helps][to] spread out liquid [on your][dag] 

Unique [cartridge] (tube][vial] with flow control 

[no drip][no mess][application][tube][cartridge][vial] 

Promotional Package Copy 

One month [dose] free 

One free month supply (dose] included 

Bonus pack 

Free (applicator](tube](vial[cartridgeO(inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

(brand] Refill Pack ]brand][applicator [device] not included] 

Refill Claims 

For use [only] with [brand name](Applicator] 

((1](3)[4([6] monthly treatments) (1](3)[4)[6] Months Supply (24)[48] doses 

Easy to use [convenient] refills 

[Can be used with] [Use with] [Brand Name] applicator 

[Brand Name] Applicator [Refillsj[Refili Pack] 

Refill Pack [forj[Brand Name] Applicator 

Refills [Refill Pack] available 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

33
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Via! 

ACTIVE INGREDIENTS: 

Elofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Melhoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Buloxide (CAS # 51-03-6), ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

~(butyl earbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fI oz (1.5 ee) (vial][tube][eartridge] (Toy Dogs)/ 

0.10 fl 02 (3.0 ee) [vial] [tube][eartridge] (SmaU Dogs)! 

0.15 fI oz (4.5 ee) (vial][tube][eartridge] (Medium Dogs)! 

0.20 fI oz (6.0 ee) (vial](tube](cartridge] (Large Dogs) 

0.30 fI oz (9.0 ee) (vial][tube](eartridge] (Extra Large Dogs) 

[ICON - DO NOT USE ON CATS] 

3 

34
SUBLABEL A - APPLICA. ,R DEVICE PACKAGE 

1. DIRECTIONS FOR USE WITH APPLICATOR 

RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AlT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for up to 30~days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that CQuid hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you. The new [brand] Applicator is specially designed to make 

applying flea and tick control easier, more precise -- and neater- than ever before. You simply insert 

the appropriate [brand] tube [vial][cartridge] for your dog into the applicator, close it and squeeze to 

apply. The applicator's ergonomic, contoured shape [design] makes it easy to grip and a built-in fin 

[tip] [comb] helps to spread [part] the [your] dog's hair to allow the liquid to more readily [better] reach 

[apply] the [to] [your dog's] skin. The tube [vial][cartridge] is sealed inside, so you can be confident 

that the liquid goes onto your dog - and not your hand. Plus, if the applicator is laid down on a table, 

counter or other flat surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. [If you choose to apply directly to dog without using the applicator device, read and 

follow the Directions for Use For Direct Application to Dog on this package.] 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 AlT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube[vial][cartridge] per dog per applicatio'l)] 

The RF2164 AlT COMBO provides a unique applicator device that allows dog OW'flPrS to tre?t 

their dogs more securely, and dispose of liquid cartridges [tubesj[vials]with less '11ess. 

4 

35
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minor differences 

relate to device features. Potential icon designs are on the last pages of this document. 

Text appearing on icon pages is for illustrative purposes only and does not represent 

full text as indicated in DFU which will appear on labeL] 

[DFU Set No.1] 

FOR [TOy][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AIT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicator device, ensuring that the 

cartridge [vial][tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid] cartridge 

[vial][tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 AfT COMBO evenly to [two 

spots](toy dogs)[three spots](small dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][button][thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 AJT COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side ]buttons together] to open 

applicator device door and discard empty cartridge [tube][vial] into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in original package.] 

6. USE RESTRICTIONS: Do not reapply product for 30 days unless re-treatment is required, 

but not sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

5 

36
FOR [LARGEJ[EXTRA LARt 

1 

• DOGS 

2 

3 

4 

5 

6 

The dog should be standing for easy application. Apply RF2164 NT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

down on the round [circle][button][thumb pad] to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. Do not spread RF2164 AfT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12~24 hours after treatment will help to 

distribute the material over the skin. 

[DFU Set No. 2J 

FOR [TOy][SMALL][MEDIUMJ SIZE DOGS 

To apply the [RF2164 AfT COMBOJ treatment, use one disposable liquid cartridge [tubeJ[viaIJ 

[for each application] with the applicator device. 

1. OPEN [iconJ 

With green [color] door facing downward, push side [buttons] to open applicator. 

2. LOAD [iconJ (3 alternate statements) 

-[To Load, insert tube [cartridge][vial] [color side down][white side up]. Press down on tube 

[cartridgeJ[vial][ until [two _[colorJJ tabs click in placeJ. 

-[To Load, place tube[cartridgeJ[viaIJunder the [color, e.g. greenJ tabsJ [in the applicatorJ 

-[To Load, place tube[cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [iconJ 

Point tip up and close the [color, e.g. green] door. The tube [cartridge][vial] will snap open and is now 

ready to apply. 

4. APPLY [iconJ 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green [color] door] [Press round thumb pad] once at each of [two] (Toy dogs) 

[threeJ (Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the 

tail. Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. 

Although the dog's skin and hair oils will naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [iconJ 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not SOO('lE::r Inan 613y~ 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applicati('lr'~] 

6 

37
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green [color] door][Press round thumb pad] once at each of four or 

five [evenly placed} spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 

6 ... 

[DFU Set No.3] 

FOR [TOY][SMALL][MEDIUM]DOGS 

To apply the [RF2164 AfT COMBOJ treatment. use one disposable liquid cartridge [tubeJ[viaIJ 

[for each application] with the applicator device. 

1. OPEN [iconJ 

Use finger scoop to lift open door. 

2. LOAD [iconJ (2 alternate statements) 

-[To Load. place tube [cartridgeJ[viaIJunder the [color. e.g. greenJ tabs Hin the applicator] 

-[To Load, place tube [cartridgej[vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [iconJ 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circleJ [[roundJ thumb padJ on green [oolorJ door once at each of [twoJ (Toy dogs) [threeJ 

(Small Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not 

apply an excessive amount of the solution at anyone spot that could cause some of the solution to 

run off the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. Although the 

dog's skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 

12~24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [iconJ 

To dispose of empty tube, open [color, e.g. green] door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re~treatment is required, but not sooner than e dc:y~ 

after the initial treatment. Do not retreat more than once per month. . 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

7 

38
FOR [LARGE][EXTRA LARG~, DOGS 

1 

2 .. . 

3 .. . 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green [color] door once at each of four or five evenly 

placed spots between the shoulder to the base of the tail. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. Do not 

spread RF2164 AfT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally 

distribute the application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

S 

6 ... 

RF2164 NT COMBO is most effective when used as part ofa total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AlT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 NT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

[TREATMENT SCHEDULE 

Dosaae: 1 [cartridael [tubel[viall everv 30 days erdoQ 

Pet's Name First Treatment Date Se~~ond Treatment Date T~ird Trea1ment D~~e 

30 Days From 1st) 30 Days From 2nd 

Reminder. I purchased RF2164 AJT COMBO from. _______ _ 

NOTES: 

Treatme·=n:-t t=a=bl=e"Cc"aC"n"b"Ce-=e"xp"'a::nCOded based on package size. (6 months)] 

STORAGE and DISPOSAL: . Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse cartridge [vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZAROS TO HUMANS AND OOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For extemal use only. Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handling and before eating, drink'lng, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using thi~ prodJct on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities r.lay o,;cur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet wich mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the applicatior, ~ite. If ~igm~: persist 

or become more severe, contact veterinarian immediately and report incidenrto COrlpany at 

1-800-XXX-XXXX. 

8 

39
FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15~20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical speCifications expressed on the label. To 

the extent consistent with applicable Jaw, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shaJJ be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, caJJ 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

WeJJmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBE/CARTRIDGEIVIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6~12 Ibs.), Small (13~31 Ibs.), Medium (32~55 Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

9 

40
Alternate Sets of ICONS for the RF2164 NT COMBO 

[ICON SET 1] 

[OPEN] 

[LOAD] 

" " 

[CLOSE] 

[APPLY] 

[DISPOSE] 

10 

41
[ICON SET 2] ALTERNATE ICOK .'OR OIRECTIONS FOR USE (will be "cific to dog's size) 

To LOAD Place tulle witt1 

WHfTEskle 

To APi>LY Use Tip to parlJur 

and gel next to dog's skin~ 

Press circle 00 green doc< 

once at each Of # spots 

t:e~.veen Shoulders 

andlal 

~SPOSE of empty tube 

too skle bu1!oos to 

dOcrand 

("#Spots" is a variable dependent on size) 

Door color may change based on brand. 

(Allernale LOAD icon) 

To lOAD place tube "h'HITE skie UP 

~rthegr~ntats 

CLOSE the green door 

and the tube wi!'! snap open.. 

11 

42
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

finger scoop to itt OPEN door 

To LOAD place tube WHITE side UP 

~rthe green tabs 

CLOSE tI1e green door 

and the tube wil snap open. 

To APPLY Use Tip to part fur 

and get next to dOg's skin. 

. PresS c:irCl€ on green door 

once at each of' spots 

between shoulders 

and tail 

tube 

: 

(U#Spots" is a variable dependent on size) 

Door color may change based on brand. 

12 

43
[2. DIRECTIONS FOR USE, _R DIRECT APPLICATION TO DOG 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. 00 not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 NT COMBO works by appfication directly to the dog's skin, not to the hair. When 

applying, manually push aside dog's hair to allow direct application to the skin. Do not get this 

product in dog's eyes or mouth. 

[(Note: Application now assumes one applicator per animal per application)J 

[Note: Each package contains sufficient tubes/applicators for [Xl applications] 

FOR [TOy)[SMALl][MEDIUM) SIZE DOGS 

1. Bend at perforation and tear off first applicator [tube]. [ 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] Hold 

applicator [tube} upright and snap tip back, away from face and body. 

3. The dog should be standing for easy application. Apply RF2164 Aff COMBO evenly to 

[two spots](toy dogs)[three spots](small or medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place 

the tip of the tube on the skin and gently squeeze to expel a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. 

4. Do not spread RF2164 Aff COMBO by hand over the dog. Although the dog·s skin and 

hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 

hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator} as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 

days after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient tubes/applicators for [X] applications] 

FOR [LARGE)[EXTRA LARGE] DOGS 

1. Bend at perforation and tear off first applicator [tube]. 

2. Hold applicator [tubeJ[and bend area of plastic at perforation, tear off and discard.J 

Hold applicator [tube} upright and snap tip back, away from face and body 

3. The dog should be standing for easy application. Apply RF2164 Aff COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At 

each spot, part the hair until the skin is visible. Place the tip of the tube on the skin and 

gently squeeze to expel a portion of the solution on the skin. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution 

to run off the side of the dog. 

4. Do not spread RF2164 Aff COMBO by hand over the dog. Although the dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tubeJ[applicator} as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment. Do not retreat more than once per month. 

RF2164 AfT COMBO is most effective when used as part of a total flea and tid.. management 

program. Use other [Brand Name} products registered for residential area contrc-I ot these 

pests in conjunction with this treatment. Monthly treatments are required for optim3: control 

and prevention of fleas. 

13 

44
[The successive feeding activit.> j fleas on dogs may elicit a hypersem. ,ty skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AfT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.J [RF2164 AJT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

[TREATMENT SCHEDULE 

Dosage: 1 [cartridge] [tube][vial] every 30 days per dog 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

i30 Days From 1 ") (30 Days From 2"') 

Reminder: I purchased RF2164 Aff COMBO from: 

NOTES.:~~~~~~~ Treatment table can be expanded based on package size. (6 months)]] 

14 

45
SUB·LABEL B FOR REF!LLPACKAGE CARTRIDGES 

(For use with applicator device or direct-application to dog without applicator 

device) 

(Front Panel) 

(Product Name] 

[Flea & Tick [& Mosquito][TreatmentJ [and] Control] 

Spot~On Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

"'(butyl carbltyl] (6-propylplperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

EPA Reg. No. 2724-811 

EPA Est No. 

NET CONTENTS: One: 0.05 fI oz (1.5 eel [vialJ[tube][cartridge[ (Toy Dogs]1 

0.10 fI OZ {3.0 eel [vial[[tubeUcartridgel (Small Dogs)! 

0.15 fI oz (4.5 cc) [viailltubeffcartridgel (Medium Dogs)/ 

0.20 fI oz (6.0 cc) [viaIWubeJ[cartridge[ (Large Dogs) 

0.30 fI oz (g.O cc) [vial][tubeffcartridge] (Extra Large Dogs) 

[ICON - DO NOT USE ON CATS] 

15 

46
(Back Panel) 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested. contact your 

veterinarian immediately. 

[RF2164 AfT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.} 

[Effective flea & tick control for your dog. 

[brand} provides flea and tick protection for dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that CQuid hatch later on. Plus, it kills and repels 

mosquitoes.} 

[Note: fuJi directions for use to be used if space allows} 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow ali directions and precautions on this product 

labe/. 

[To apply the RF2164 AfT COMBO treatment with the [Brand Name] applicator. use one 

disposable liquid cartridge [tube][vialj[for each application] with the applicator device.] 

[Remove one refill tube [cartridgeJ[vial] from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device.] If you need directions for application, please call 1-800-XXX-XXXX. 

[However, if you choose to apply directly to dog without using the applicator device, read and 

follow the Directions for Use For Direct Application to Dog on this package.] 

(DIRECTIONS FOR USE FOR DIRECT APPLICATION TO DOG) 

[USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 Aff COMBO works by application directly to the dog's skin, not to the hair. When 

applying, manually push aside dog's hair to allow direct application to the skin. Do not get this 

product in dog's eyes or mouth. 

16 

47
[(Note: Application now assur., .,j one applicator per animal per applicc.. (1)] 

[Note: Each package contains sufficient tubes/applicators for [X] applications] 

FOR [TOy][SMALL][MEDlUM] SIZE DOGS 

1. Bend at perforation and tear off first applicator [tube]. [ 

2. Hold applicator [tube][and bend area of plastic at perforation, tear off and discard.] 

Hold applicator [tube] upright and snap tip back, away from face and body. 

3. The dog should be standing for easy application. Apply RF2164 AIT COMBO evenly 

to [two spots](toy dogs)[three spots](small or medium dogs) on the top of the back from 

the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. 

Place the tip of the tube on the skin and gently squeeze to expel a portion of the 

solution on the skin. Do not apply an excessive amount of the solution at anyone spot 

that could cause some of the solution to run off the side of the dog. 

4. Do not spread RF2164 AIT COMBO by hand over the dog. Although the dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube][applicator1 as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment. Do not retreat more than once per month. 

{Note: Each package contains sufficient tubes/applicators for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1. Bend at perforation and tear off first applicator [tube]. 

2. Hold applicator [tube][and bend area of plastiC at perforation, tear off and discard.] 

Hold applicator [tube] upright and snap tip back, away from face and body 

3. The dog should be standing for easy application. Apply RF2164 AIT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At 

each spot, part the hair until the skin is visible. Place the tip of the tube on the skin and 

gently squeeze to expel a portion of the solution on the skin. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solurlon 

to run off the side of the dog. 

4. Do not spread RF2164 AIT COMBO by hand over the dog. Although the dog's skin 

and hair oils will naturally distribute the application over the entire dog, brushing the 

dog 12-24 hours after application will help to distribute the material over the skin .. 

5. Discard empty [tube1[applicator1 as described in Storage and Disposal 

6. Do not reapply product for 30 days unless re-treatment is required, but not sooner than 

8 days after the initial treatment Do not retreat more than once per month. 

RF2164 AIT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AIT COMBO rapidly 

kills fleas and may reduce the incldence of this condition.] [RF2164 AIT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

17 

48
[TREATMENT SCHEDULE 

Dosaae: 1 rcartridaelrtubelrviall every 30 davs erdoQ 

Pet's Name First Treatment Date Second T reatment ~~te Third Treatment D~~e 

(30 Davs From 1st (30 Davs From 2

nd 

Remrnder. I purchased RF2164 AfT COMBO from. _______ _ 

NOTES: 

Treatme"n"tt=a"bl::e-:c"a=-n"b"e-:e"xp"a=n'"ded based on package size. (6 months)]] 

(Precautionary/First Aid and StoragelDisposal) text included) 

WARRANTY AND CONDITIONS OF SALE: 

SeUer warrants that this product conforms to the chemica! specifications expressed on the label. To 

the extent consistent with applicable law, SeUer makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-BOO-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

18 

49
Wellmark" 

June 14,2011 

Richard Gebken, PM 13 

Registration Division (AMEND) 

Office of Pesticide Programs (7505P) 

U.S. Environmental Protection Agency 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington V A 22202 

James McFadden, Ph.D. 

Wettmark International 

Subject: Submission of Label Amendment for a Product Containing Etofenprox: 

EPA Reg. No. 2724·811; RF2164 AIT COMBO 

Dear Mr. Gebken: 

Enclosed with this letter please find material to support a label amendment for Wellmark 

International's product RF2164 AfT COMBO (EPA Reg. No. 2724-811). The purpose of this 

amendment is to add uses on puppies to the existing label. We are also making a minor revision to the 

statement regarding potential adverse effects. 

The basis for this amendment, however, is discussed at length in a concurrently submitted label 

amendment for a related product, Well mark EPA Reg. No. 2724-796, the RF2042 [COSO]. That 

submission includes an additional report for review, revised data matrix, etc. 

The label amendment for the 2724-811, RF2164 AfT COMBO depends entirely on the data submitted 

with that application. Therefore, as far as we understand, this application (for 2724-811) should be 

classified as a secondary submission under PRIA category R340.1, since we expect the other 

submission to be R340, and is the primary submission. A check in the amount of $904.25 (1I4th of the 

PRIA R340 fee) has been submitted to the government lockbox in S1. Louis, and a copy is enclosed 

with this submission. 

Because supporting material was included with the submission for 2724--796, this application for a 

label amendment contains only: 

Form 8570-1, Application for label amendment 

Revised label (5 copies) 

Please let me know if you have questions or need more infonnation regarding this submission. 

Regards, 

:Gmes 

~~ McFadden, Ph.D 

Sr. Regulatory Project Manager 

Page 1 of 1 

50
REGULATORY LABEL DATA SHEET 

File Name: 

Product: 

Approved: 

OVERVIEW: 

Page # 

1·2 

1·9 

Epa amend add puppies 

611 

RF2164 AfT COMBO 

Data Sheet Date: 

EPA Reg #: 

Supercedes: 

June 2011 

2724·811 

3/9/11 

Label amendment to add puppies 10 weeks of age or older 10 label 

Description of Major Changes 

Marketing claims: Added general claims regarding use in households with cats 

Added efficacy claim: "Controls fleas, ticks, and mosquitoes for up to one 

month][Monthly treatment for control of fleas, ticks and mosquitoes] 

Added "pod" as additional optional term for tube/vial in thermoform claims 

Added refill claims 

Added use on puppies 10 weeks of age or older 

Directions for Use: incorporated 3 sets of alternate directions into one set for 

toy/small/medium and large/extra large dogs/puppies 

1 

51
HF2164 AfT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Panel- For Use Only on Toy (6-12 Ibs.). Small (13-31 Ibs.), Medium (32-55Ibs.), Large (56 -80 

Ibs.), and Extra Large (81Ibs. and over) Dogs/Puppies 10 Weeks of age or older 

Front Panel- For Use Only on DogS/Puppies 10 Weeks 6 months of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks of age or older 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide [smaller] weight ranges to improve [maintain][deliver] efficacy 

[performance][flea and tickj[control][protection[ on [for] your dog/puppy 

Effective on indoor and outdoor dogs/puppies 

([1][3[4[[6] monthly treatments) [t [3[4[6] Months Supply [24][48] doses 

Spreads naturally with dog's/puppy's movement (skin and hair oils) 

[Formula][Contains lanolin for coat conditioning[ 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

[Fast Acting][Long Lasting][Kills Fleas and Ticks by Contact] 

[Fresh][Clean][[Scent][Smell] 

[Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

[Incidental exposure of cats to this product is not likely to cause harmful effects] 

[Can be used in households with dogs and cats] 

[Based on testing, accidental exposure to cats from this product is not likely to cause serious harmful 

effects.] 

Efficacy Claims: 

Each tube [cartridge][vial] [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4[ Weeks[One month][Four/4 Week [Flea][Tick[[Mosquito] Treatment] 

[Controls fleas, ticks and mosquitoes for up to one monlh[ [Monthly treatment for control of fleas, ticks 

and mosquitoes[ 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hours[[Kilis more than 50% of fleas in 2 hours[ 

[Dual Action kills adult fleas and prevents flea development[ 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae[ [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm-) 

Monthly application for mosl effective protection 

IGR Claims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea developm,:,'nt '~6r 

[more than 10 weeks] up to [75 days][2.5 months[[ 

[Breaks Flea Life Cycle for [more than 10 weeks[ up to [75 days][2.5 months[ 

[Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR[ to Break Flea Life Cycle] 

1 

52
Applicator Claims 

]New] [applicator] 

[New] contemporary design 

[brand name] [Applicator] helps to prevent getting liquid on ]your] hands 

[brand name] [Applicator] tip parts hair to help [liquid][application] get down to [the][your[[dog's/puppy's] skin 

Ergonomically contoured ]ergonomic][shape][design] for easy handling [ease of use] [easy use] 

For use with [only][brand namelldisposable][liquid dispensing] tubes ]pods] [vials] [cartridges] 

]brand name]]applicator][has]]providesllallows for]]delivers] better grip 

[brand name][provides] re-closable [re-sealable] packaging for] easy] storage 

Closing [the][brand name][applicator] door automatically opens the [disposable][liquid dispensing] tube 

[podllviamcartridge] 

]brand name]]Applicator]]will not drip after opening] 

]brand name] [Applicator] Won't drip when set down as you go fetch the ]your] dog/puppy 

Includes unique [brand] applicator 

Puts the liquid on your dog/puppy - not your hands 

Directs the liquid onto your dog[/puppy] - not your hands 

Directs the liquid onto your dog]/puppy]- away from your hands 

Applies liquid to your dog's]/puppy's] skin - not yours 

Helps prevent applying the wrong spot-on ]dose] [product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs/puppys 

Thermoform claims 

New 

New ]disposablellliquid dispensing] tube [cartridge][vial][pod] 

(Note tube/vial/cartridge/pod used interchangeably) 

]New]]brand namelldisposablellliquid dispensing] [tube][viaillpod] tip ]helpsllto] spread out liquid Jon 

yourlldog/puppy] 

Unique [cartridge] [tube][vial][pod] with flow control 

[no drip]]no mess]]application][tube][cartridge][vial][pod] 

Promotional Package Copy 

One month [dose] free 

One free month supply ]dose] included 

Bonus pack 

Free] applicato rll tube] [vial] cartrid ge II podlll i nsid e] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator]device] not included 

]brand] Refill Pack]brandj[applicator]device] not included] 

Refill Claims 

For use [only] with ]brand name][Applicator] 

([1113114[[6] monthly treatments) [1][3114116] Months Supply [241148] doses 

Easy to use ]convenient] refills 

[brand name [e.g., Adams or 8io Spot)] [brand name [e.g., Smart Shield)] [applicator] 

[tube][cartridge][vial][pod]refill pack [refills] 

Refill pack 

New [refililltubellcartridgellviaillpod] design 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

53
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etolenprox (CAS # 80844-07-1 ) .................................................................... 30.0% 

S-Methoprene (CAS # 65733- t6-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*(butyl earbilyl) (6-propylpiperony! elher) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fl oz (1.5 ee) [vial][tube][eartridge] {Toy Dogs)/{and Puppies] 

0.1011 OZ (3.0 ee) [vial] [tube][eartridge] (Small Dogs)l[and Puppies] 

0.15 fl oz (4.5 ee) [vial][tube][eartridge] (Medium Dogs)/{and Puppies[ 

0.20 fl OZ (6.0 ee) [vial][tube]leartridge] (Large Dogs)/[and Puppies] 

0.30 II oz (9.0 ee) Iviallilube][eartridge] (EXira Large Dogs)[and Puppies] 

[ICON - DO NOT USE ON CATS[ 

3 

54
RF2164 AIT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES. DO 

NOT USE ON OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2t64 Aff COMBO] prevents flea eggs from developing into adult fleas [more than to 

weeks] for up to [75 days1l2.5 months]. RF2t64 Aff COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog/puppy_ 

[brand] provides flea and tick protection for dogs/puppies for up to 3~-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier, more 

precise -- and neater - than ever before. You simply insert the appropriate [brand] tube 

[vial][cartridge] for your dog/puppy into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design] makes it easy to grip and a built-in fin [tip] [comb] helps to 

spread [part] the [your] dog's/puppy's hair to allow the liquid to more readily [better] reach [apply] the 

[to] [your dog's/puppy's] skin. The tube [vial][cartridge] is sealed inside, so you can be confident that 

the liquid goes onto your dog[/puppy] - and not your hand. Plus, if the applicator is laid down on a 

table, counter or other flat surtace, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make, the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 Aff COMBO works by application directly to the dog's[/puppy's] skin, not to the,l)",ir, ' 

When applying, use applicator device tip to push aside dog's[/puppy's] hair tv-ali")",J dire(;t 

application to the skin. Do not get this product in dog's[/puppy's] eyes or mouth.' , 

[(Note: Application now assumes one tube[vial][cartridge] per dog[/puppy] per~pplication)] 

The RF2 t64 AfT COMBO provides a unique applicator device that allows dog/puppy owhe-rs ' 

to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubesj[vials]w;Vl 

less mess. 

4 

55
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[Note: This label contains alternate. independent sets of Directions For Use. which are 

provided to allow for flexibility in device manufacturing. Each set of DrU has the same 

6 steps: Open. Load, Close, Apply, Dispose, Use Restrictions, so the minor differences 

relate to device features. Potential icon designs are on the last pages of this document. 

Text appearing on icon pages is for illustrative purposes only and does not represent 

full text as indicated in DFU • .... hich '.:'.'iII appear on labeL1 

[DFU Set No.1] 

FOR [TOYJ[SMALL][MEDlUM] SIZE DOGS/PUPPIES 

To apply the [RF2164 AfT COMBO] treatment. use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Holding tho applisator devise in ono hand, push the side [buttons] to open the devise. 

1. OPEN Qcon] 

With green door fasing downward, push side [buttons] to open applicator. 

1. OPEN [icon] 

Use finger scoop to lift open [color, e.g. green] door. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicater device, ensuring that the 

sartridge [vial][tube] fits sesurely in the slots inside the applisator devise. 

2. LOAD liGon] (a alternate statementG) 

[To Load. insert tube [Gartridge]p/ial] [color cide downjfwhite side up]. Press down on tube 

[cartridgejf¥ialjf until [two greon] tabs click in place]. 

[To Load, place tube[cartridgejf'lial]undor the [color, e.g. green] tabs] [in the applicator] 

[To Load, place tube[cartridge][vialj-white side up into the applicator] 

[Ensure that tube [sartridge][vial] fits sesurely in the applicator.] 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]white side up into open applicator with front of tube placed under 

tab on door. 

-[To Load, place tube [cartridgeJ[vial] white side up into the [open] applicator with tip end of tube 

placed under the [color][U-shaped] tab on door] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Point the applicator devise tip up'Nard and close the lid. The disposable [Iiqujd] r-artrid§C' ' ' 

[vial][tubeJ will automatisa!!y be clipped open and is now ready to be applied to Y3:.H 

doglpuppy. 

3. CLOSE [icon] 

Point tip up and close the [color, e.g. green] door. Tho tube £cartridge)tvial) will snap OPO/l d'110 is now 

ready to apply. 

3. CLOSE [icon] 

Gently close the [color, e.g. green] door [and] the tube will snap open. 

5 

56
4. APPLY liGon] 

The dog/puppy should be Gtanding for easy appliGation. Apply RF2164 NT COMSO ovenly to 

[two spotsj(toy dogslpuppies)[three GPots](small dogs/puppios)(medium dogslpuppies) on the 

top of the baal", from the shoulder to the base of the tail. At each spot, use the tip of the 

appliaator device to part the hair until the skin is visible. Then push down on tho round 

[circle][button][thumb pad] to dispense a portion of the solution on the sl<in. Do not apply an 

mmessivQ amount of the solution at anyone spot that Gould Gause some of the solution to run 

off the sido of the dog/puppy. Do not sproad RF2164 AfT COMSO by hand over the 

doglpuppy. Although the dog's sl(in and hair oils will naturally distribute tho applioation over 

tho entire Elog,lpuppy, brushing tho doglpuppy 12 24 hours after treatment ' .... il! help to distribute 

the material over the sl(in. 

4. APPLY liGon] 

Tho doglpuppy should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's/puppy's skin. [Press circle on green door] [Press round thumb pad] onee at each of [two] (Toy 

DogS/Puppies) [three] (Small DogS/Puppies)(Medium Dogs/Puppies) evenly plaGod spots between tho 

shoulder and the base of the tail. 

Do not apply an Q)(cessive amount of the solution at any ene spot that could cause seme ef the 

solution to run off the side ef the deg/puppy. Do not spread Rf-2164 NT COMBO by hand over the 

dog/puppy. Although tho dog's/puppy's sl<in and hair oils '.vill naturally distribute the application over 

the entire dog/puppy, brushing the dog 12 24 hours after treatment will help to distribute tho material 

over the s!{in. 

4. APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicatorHtip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on [color -green] door 

[number -once] at each of [two] (Toy Dogs/Puppies) [three] (Small Dogs/Puppies) (Medium 

DogS/Puppies) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 AfT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5. DISPOSE liGon] 

VI/hen finished, held applicator device ever trash. Push side [buttons together] to open 

applicator device door and discard empty cartridge [tube][vial] into trash or o,ifcr fN recycling if 

available. [Close applicator device dear and store [applicator device] in original paclmg'G.~ , 

5. DISPOSE liGon] . . .• . . 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into tFQsh"cr offer fer' rssycling if 

available. [Close applicator device door and store in original package.] 

5. DISPOSE [icon] 

[When finished, hold applicator device over trash.] To dispose of empty tube, open [color, e.g. green] 

door and drop empty tube into trash or offer for recycling if available. [Close applicator ~<}\/;G& door 

and store in original package.] 

6. USE RESTRICTIONS: (2 alt. statements) 

-Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days after the 

initial treatment. Do not retreat more than once per month. 

6 

57
- If necessary, product can be reapplied, but not sooner than 8 days after the initial treatment. Do 

not retreat more than once per month. 

§., 

[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications] 

FOR [LARGE][EXTRA LARGE] DOGS/PUPPIES 

1 

2 

3 

4 APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator[[tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door 

[number~once] at each of four or five evenly placed spots between the shoulder to the base of the taU. 

Do not apply an excessive amount of the solution at anyone spot that CQuid cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2t64 AfT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy t2-24 hours after treatment will help to distribute the 

material over the skin. 

4 

5 

6 

[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications] 

RF2t64 NT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skir. 

disorder known as flea allergy dermatitis (FAD). Treatment of dogs/puppies with RF216;l,Lv T 

COMBO rapidly kills fleas and may reduce the incidence of this condition.] [RF2164 AI': ' , 

COMBO is water resistant and remains efficacious following exposure to rajn~~11 ()r swimmi)1g.] 

TREATMENT SCHEDULE . 

Dosage: 1 [cartridge tubeJ[vialJ every 30 days per dog[/puppYI 

Pet's Name First Treatment Date Second Treatment Date ThirdTr'33~ment Date 

(30 Days From t

st) (30 0"10 From 2"") . 

Reminder: I purchased RF2164 AfT COMBO from: 

NOTES:"C":'7C_~ __ _ 

Treatment table can be expanded based on package size. (6 months) 

7 

58
STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tubej Disposal: If empty: Do not reuse cartridge [vial[ 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS/PUPPIES LESS THAN 10 WEEKS6 MONTHS OLD. For external use only. 

Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and 

water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. 

Repeated exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this 

product on debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur 

after using ANY pesticide product for pets. If signs of sensitivity occur, bathe your-!'**dog with mild 

soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some ~dogs may experience hair loss or temporary skin irritation at the application site. If signs 

persist or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

8 

59
TEXT FOR LIQUID TUBElCARTRIDGEIVIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12Ibs.), Small (13-31 Ibs.), Medium (32-55Ibs.), large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs/Puppies 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

'"(butyl carbilyl) (6-propylpiperonyl ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a mannerinconsistent with its labeling. Read and follow all directions and precautions on this procli.Jc~ 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid cC'rtt'ic1ge 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube [cartridge][vial] from the package and insert into openeU [orand n,amel 

applicator device. Make appiicaflon according to label directions supplied with the [bran(\" 

name] applicator device. If you need directions for application, please call 1 ·800"XXX"XXXX. ", ' 

(Precautionary and Storage/Disposal) text included) 

Well mark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

9 

60
Icon Set for the RF2164 AfT COMBO 

[ICON SET 1] 

Directions for Use 

For MB:Ilrn CqJs (32 -55 Ibs) 

To apply the treatment, use applicator device with ONLY 

ONE liquid tube per application f per dog 

Use finger to lift OPEN green door "" ... 

To LOAD place tube WHITE side UP 

into applicator with tip end of tube 

placed under on door 

Gently CLOSE the door 

and the tube will snap open. 

To APPLY Use tip to part fur 

and get next to dog's skin. 

Press circle on green door 

at 3 spots between 

shoulders and tail 

("#Spots" is a variable dependent on size of dog) 

10 

61
AcHon Code History 

Secondary Decision 

62

PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPNOPP Use Only) 

3/23/09 

21 Day Screen Start Date: ((, - I 7 - II 

Experts In-Processing Signature: nr I~A;f.IN6;o"" Date G-Z/- 1/ Fee Paid: Yes ~ Division management contacted on issues No Yes Date ______ _ 

EPA Reg. Number: 2. 7 L '-I _ £ { I EPA Receipt Date: c, - /7- / 

Items for Review Yes No N/A* 

1 

2 

3 

Application Form (EPA Form 8570-1)(1ink to form) signed & complete 

including package type 

Confidential Statement of Formula all boxes completed, fonn signed, mld 

dated Fonn to 

a) All inerts (link to http://www.epa.gov/opprdOOllincrts/), 

including fragrances, approved for the proposed uses (see 

Footnote 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to 

form) completed and signed (N/A if 100% repack) 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

yes no 

I ~~-t~~~~~~;:~~~O~f~~~ 4 completed and (N/A if somce is umegistered or applicant owns the 

5 

6 

Data Matrix (EPA Form 8570-35) (Link to form) both internal and external 

copies (PR 98-5) (Link to PR 98-5) completed and signed (NI A if 100% 

Selective Method 

b) Cite-All (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

5 Copies of Label (link to http://www.epa.gov/oppfeadl/1abelinglIrml) 

(Electronic labels on CD are encouraged and guidance is available)( link to \..-

http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#lab els /\ 

1 

x 

64
7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) -,( 

Notice of Filing (link to 

8 htt~://www.eQa.gov/l!esticides/regulating/tolerance Qetitions.htm) included 

with petitions (liuk to )( htlp:!lwww.epa.gov!pesticidesJregulating/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOllworkpian/reducedrisk.html) \ 

Required Data Clink to 

h ttl! ://www .eRa.gov 'I!esti ci des/reguiatin eI data reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

10 

2 

65
Comments: 

\0 e..r r ov\..rL~_,- 'A7 c\ ... ; M-ir..-5 

C\"FA 0 J;- ~~f, d'~\;d\'\I' 

(A",\ -,,)L"\- CV{("-L'\\,,,,-) 

5-\K)1 

1"1(",,--1'1 ID CJ) c,~ I, J"\"\;j \'r "' '"FP"',,"J~l 

""'- n.:J"\~'A\- w "5 ('A\"hi GO-"II\ 

-\0 (-\\0" c ~ \ --' SL1Z ~ 

s-\ Kj,L> t"55cJ. 

:J~(,k'C+ "sSeJ, 

* N(A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all illerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the CSF, etc. or 2) provide the data to support opp approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All information, forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise. the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even ira product is currently registered by consulting the inert Web 

3 

66
site [link to http://www.epa.gov/opprdOOllincrts/list.s.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (IlAB) at illertsbranch@epa.govandresolvetheissue. Copies of the 

correspondence with IIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by lIAB. The lIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm ]. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional infonnation such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

to enable the Agency to detennine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must anange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21 ~day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the infonnation and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

67
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 2l-day 

contenHeview period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

68
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R30I or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

69
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

June 21, 2011 

OPP Decision Number: D-450780 

EPA File Symbol or Registration Number: 2724-811 

Product Name: RF2164 NT COMBO 

EPA Receipt Date: 17-Jun-2011 

EPA Company Number: 2724 

Company Name: WELLMARK INTERNATIONAL 

JAMES MCFADDEN, PH.D. 

WELLMARK INTERNATIONAL 

1501 E. WOODFIELD ROAD, SUITE 200 WEST 

SCHAUMBURG, IL 60173 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Amendment Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your amendment and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has detennined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R340.0 

NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTIONARY LABEL 

STATEMENTS;NO FEE: LINKED TO A PRIA APPLICATION; 

The fee for this action is $0. You have paid $904.25 towards this action (Check No. 

l068403). This amount will be refunded to you when the action is completed. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Front 

Sincerely, 

~ 

End Processing ~ Staff 

Infonnation Technology & Resources Management Division 

70
IFee for Servicel 

("1 

{898013Er-------------------------------------------------------------------------------

This package includes the following 

o New Registration 

@Amendment 

for Division 

OAD 

oBPPD 

@RD 

I'ii Studies? D Fee Waiver? 

Risk Mgr. DIJ . Dvolpay % Reduction: __ 

c---- ------ ----- -- - --------------- - -- ------------ ----- ---------- ----- -- ------------------------------------- ----

Receipt No. s-I 898013 

EPA File Symbol/Reg. No. 1 2724-811 

Pin-Punch Date: 1 6/17/2011 _____________________ _ __________________________________________________________________ _ "'_n_" ______ " __ __ __ _________ __ __ ___________ ________________________________________________________ _ ____________________ , 

,-----' This item is NOT subject to FFS action. 

--Actiun-Cude: 

Requested: I~ 3 L\ 0. \ I 

Granted: f§'--\.o ,0 I 

Amount Due: $ ~ 

Parent/Child Decisions: 

. \? c-./<"'-"-\- "21 'Z. ~I. - "I '. '= 

L~~~ ::<'12'-l- i:5-l \ 

D .Inert ClearEJff~~-=se B Uncleared Inert in Product 

ReViewer: ;f-~q ~ Date: b --:L , - L\ 

Remarks: 

71
72
Please read instructions on reverse before completing form Form Approved OMS No 2070 -0060 Approval expires 2 -28 -95 

§ , OPP Idenlifler Number United States Registration n EPA ~, Environmental Protection Agency Amendment , Washington, DC 20460 Other 

ApPlication for Pesticide ~ Section I 

1. CompanyrProduct Number ; 2. EPA ProduCI Manager I 3. Proposed Classificalion 

Wellmark International12724-811 Richard Gebken ! 

, - , 

4. CompanylProduct o None (Name) PM' I D Reslricted 

Wellmark International/RF2164 AfT Combo 13 i ~~~-----~-~-~--~- i 

5. Name and Address of Applicant I Registrant (Include ZIP COlle) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3) 

Wellmark International (b)(i), my product is similar or identical in composition and labeling to: 

1501 East Woodfield Road, Suite 200W EPA Reg. No 

Schaumburg, Illinois 60173 ~~- ._---_ .... _------. 0 .•. ' __ '''' 

Product Name ._-- -~~~--

---- D Check if rhis is a new address , 

Section - II 

D Amendment - Explain below. ~ Final printed labels in response '0 

Agency M?rch 9, 2['11 letter daled D Resubmission in response to Agency letter dated D "Me Too" Application 

~~~--.-- --------

._----- ........... _--_.--

D Nolif,cation - Explain below. D Olher - Explain below. 

.-'-_._. ----_._--- --.-..!--~~~ 

Explanation: Use addi~onal pagels) il necessary. (For section I and section II.) " 

Enclosed please find materials to support a label amendment intended to add puppies to the label for this product. One study has b"en submitted with a 

concurrently submitted amendment for 2724-796 that is also intended to support this applicaton. Since this application is related to ~f]e, ~n:,~ndment for 

2724-796 and is supported by the same data, we expect this actIon to be assigned to PRIA Category R340.1. A check for $904.25 (tf4th of the R340 

Fee) has been sent to the appropriate government lockbox in St. louis. For questions, contact: James McFadden; Tel: (847) 330-5369, Fax: (847) 330-

5369; E-Mail: jmcfadden@centraJ.com 

Section - III 

1. Material This Produc1 Will be Packaged In: - _._-_._---_. __ --0 __ • 

Child-Resislant Packaging Unil Packaging Water Soluble Packaging 2. Type of Container 

@y" By" @Y" X No ~~lli' X Plastic No 

X "' -------- '''--''-'----_ ... - -------- --------i Glass .. --~~--.. ----~~--

If "Yes Unit No. per i If '"Yes Unit No. per X Paper 

* Certmcation must be Packaging wgl. conlainer . Packaging wgl. conlainer Other (Specify) -0------. --- - -- ... _- .. _---_ .. -

s/1bmftted • , . ______ . ___ .. ___ L --- ----- ... _ ... _---.. - ---------- ... ----~~~.---~~~ ------ ------ - --~ 

3. Localion of Nel Contents Intormalion 4. Size(s) Retail Conlainer 5. Location of Label Direclions 

o Label o Container 

, 8 On Label 0.05 - 0.30 fl 02 (1.5 - 9 ee) tubes .. ____ On Label Accompanying Produci -- __ ~ _____ .o .--... , . __ ._-- ... _--_._. ._._--

6. Manner in Which Label is Affixed 10 Product § lIlhograph '''~'---~-~~~-r prinled on cardboard 

Paper glued ~----~~--

Slenciled 

Section -IV 

1. Contact Point IComplete items directly be/ow for i~!!.nrificati0r:. of individual to be contacted, if necessary, to process this application.) ~ 

Name : Title Telephone No. (Include Area Codel 

James McFadden Sr. Regulatory Project Manager 847-330-5376 

~--~~--~.--. -----.---~~~-." .. . __ . __ ._ .. - ---~~--~~---- - - ----~------ - ---.. ~-.---- .. .. _--- ._._.-

Certification 6. DaleApplicalion 

I certify that the slatemenls I haue made on this form and all attachments Iherelo are true, accurate and complete. , Recei~ed 

acknowledge that any knowingly false or misleading stalements my be punishable by fine or imprisonment or both (Stamped) under applicable law. 

--~-----~~--------~--- ------- -~-~ --_. --.. --~------- __ .... o_" .. ~~ ... ." .. "--... ----~.--"-.------

2. Signature ~ 3. Tille 

Sr. Regulatory Project Manager 

--~~ .. ~---- --------~ -- --- -- ....... ---~~- _ .. _----- -- -~~. 

.... -- -- .... - ... ------~-- --_._ .. _---

4. Typed Name 5. Dale 

James Mcfadden June t4, 2011 ; 

i 

EPA -- Form 8570-1 (Rev. 3.94) PrevIous ed,tions are obsolete. - " While , EPA File Copy (0 g nal) Yellow . Appllcantcopy 

73
Wellmark" 

June 14, 2011 

Richard Gebken, PM 13 

Registration Division (AlvlEND) 

Office of Pesticide Programs (7505P) 

U.S. Environmental Protection Agency 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington VA 22202 

NR 486117-00 

James McFadden, Ph.D. 

S; R~gulalor:v PrOlect Manager 

Wellmark International 

150~ E. Woodfield Rd 

Svite 200W 

Schaumburg,IL 6017.3 

347·330·5369 prlcHce 

347·330·53£'1 ;ax 

:rnc;adden@central,com 

;Nww.cer"raIHfesciencss.com 

Subject: Submission of Label Amendment for a Product Containing Etofenprox: 

EPA Reg. No. 2724·811; RF2164 AIT COMBO 

Dear Mr. Gebken: 

Enclosed with this letter please fmd material to support a label amendment for Well mark 

International's product RF2164 Aff COMBO (EPA Reg. No. 2724-811). ~he purpose of this 

amendment is to add uses on puppies to the existing labeL We are also making a minor revision to the 

statement regarding potential adverse effects. 

The basis for this amendment, however, is discussed at length in a concurrently submitted label 

amendment for a related product, Wellmark EPA Reg. No. 2724-796, the RF2042 [CDSO]. That 

submission includes an additional report for review, revised data matrix, etc. 

The label amendment for the 2724~811, RF2164 Aff COMBO depends entirely on the data submitted 

with that application. Therefore. as far as we understand. this application (for 2724-811) should be 

classified as a secondary submission under PRLA category R340.1, since we expect the other 

submission to be R340, and is the primary submission. A check in the amount of $904.25 (l/4th of the 

PRLA R340 fee) has been submitted to the government lockbox in St. Louis, and a copy is enclosed 

with this submission. 

Because supporting material was included with the submission for 2724-796, this application for a 

label amendment contains only: 

Form 8570-1, Application for label amendment 

Revised label (5 copies) 

Please let me know if you have questions or need more infonnation regarding this submission. 

Regards, 

~~~'McFadden, L~ Ph.D 

Sr. Regulatory Project Manager 

74
Wellmark" 

June14,201l 

Richard Gebken, PM 13 

Registration Division 

Document Processing Desk 

Office of Pesticide Programs (7505P) 

U.S. Environmental Protection Agency 

Room S4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington V A 22202 

James McFadden, Ph.D. 

We!lmark International 

1501 E. VVoOd~'2id 8d 

Sliit" 200W 

Schau;nburg, il 5C173 

Subject: Submission of Label Amendment for a Product Containing 1i:tofenprqx: 

EPA Reg. No. 2724-796; RF2042 (CDSO) 

Contains Confidential Business Information (Discussion of Inert Ingredients) 

Dear Mr. Gebken: 

Enclosed with this letter please find material to support a label amendment for Wellmark 

International's product RF2042 (CDSO) (EPA Reg. No. 2724-796). The purpose of this amendment 

is to add uses on puppies back to the existing label. After the RF2042 (CDSO) was registered, 

(3/10/2009) the companion animal safety study for puppies was rejected, (MRID 47622203, DP 

Barcode DP 360171) forcing us to delete that use from the product label. 

Since the initial rejection of that study, Wellmark has made several attempts to get puppies added back 

to the label. Wellmark submitted a report amendment (MRID 4783530 1, 8/24109) that addresses 

issues identified by the Technical Review Branch (TRB) in the review for the original puppy 

companion animal safety study; the issue has also been discussed in other letters and in a meeting with 

EPA in January of 2010. 

This submission collects the arguments submitted previously, provides an additional report as 

supporting data, and ties all of this to a request to approve specific label language submitted with this 

label amendment. 

Because this submission will not require review outside of RD, we expect the submission will be 

classified as PRIA category R340, and will have a 4-month review time. PRIA category R340 has a 

PRIA fee of $3617, and a check for that amount (copy enclosed) has been submitted to the designated 

government lockbox in St. Louis. 

Page I of5 

75
Label Amendment, 2724-796 

The application for label amendment includes the following components: 

Form 8570-1, Application for label amendment 

Revised label (5 copies) 

Form 8570-34, Certification with Respect to Citations of Data 

Form 8570-35, Revised Data Matrix 

Transmittal Document for one study submitted with this application 

The following paragraphs discuss this submission in more detail: 

Background for the Amendment 

In order to understand the background for this amendment, we first provide a summary of recent 

regulatory actions related to this product. Essentially, the reviews that EPA has provided for previous 

actions constitute the background for evaluation of this amendment. 

Date Action/Issue Data 

3/10/2009 Notice of Registration OriO'inal submission -- 6/04/2009 Amend to Remove Puppies, CAS Study rejected MRID 47622203, DP 360171 

(study oriO'. submitted with 2724-797) (dated 5/2212009) 

8/24/2009 CAS Report Amendment, DER Rebuttal submitted, MRID 47835301 

non-PRIA -- 8/3112009 Label Amendment for safety to cats and changes in Reference to rviRID b651:~d09, 

dose groups (4 - 5) (CAS in cat~)~ HRID ~~84~Q.Q..L 

111912010 Amendment to change dose groups approved, DP 369326, 12109/2009 

safety to cats not approved 

112812010 Meeting with EPA to discuss pet issues and MRID 

47835301, EPA recommended submission of a 

PRIA action. 

2124/2010 Amendment to add puppies and kittens to pet spray DP376421, 6/23/2010 (review 

submitted, also requested review for 2724-796 did not consider 2724-796) 

CAS = Compamon Anlmal Safety 

From DP 360171. 5/2212009, where EPA rejected the puppy companion animal safety study: 

TRB's primary concern is that adverse effects - even though they could be considered as minor (loose 

feces and vomiting) - occurred following IX exposure (use application rate) to the test material. 

Considering that only 12 puppies were tested at 1 X, the occurrence of effects in two indicates a high 

potential for adverse incidents - including some of greater severity - if the formulation is registered for 

use as a spot-on for puppies. Even if nothing abnonnal had been observed at IX, the occurrence of 

adverse effects at 3X (one male had a bloody fecal discharge and vomiting on Day 1, and loose stools 

on Days 2 and 3; another male had vomiting on Day 1) would indicate a less than 3X margin of safety 

for this use on puppies. Since there is an inadequate margin of safety, the study is classified as 

unacceptable and cannot be used to support the use of this formulation as a spot-on for puppies. 

From DP 369326. 12/09/2009, where EPA raised additional concerns about the dog topical: 

2. Although the material in MRID 478440QI references studies on cats and kittens conducted 

With etofenprox -containing formulations in which no significant adverse effects were observed, the 

Agency has received incident reports for both the primary registration (2724-504) and distributor 

products (2724-504-270 and 2724-504-2S96) of a 40% Etofenprox and 3.6% S-methoprene 

containing formulation. These incidents include a total (for 2008) of 82 deaths (by all exposure routes) 

in cats or kittens. In addition, the presence oflanolin in 2724-796 creates a potential problem, as some 

cats (particularly Siamese) may be attracted to lanolin (see http://www.messybeastcomipica.htm). and 

may go out of their way to lick lanolin-treated items. It is also noted that 2724-504 does not contain 

Page20f5 

76
Label Amendment, 2724-796 

piperonyl butoxide, which is present in 2724-796 and which could enhance the toxicity of the 

etofenprox to the cat. Based on these considerations TRB recommends against any statement 

indicating that accidental exposure to cats from treated dogs will not cause serious harmful effects. 

3. Based on the incident reports for EPA Reg. No. 2724-504 and the attractiveness of lanolin to some 

cats, TRB strongly recommends that lanolin be removed from 2724-796. Otherwise some cats in 

multiple-pet households will ingest this product by licking or grooming the dog's treated coat. 

From: DP376421. 6123/2010, where EPA accepted adding puppies to the spray. but did not address the 

spot on: 

Based on the low number and transient nature of effects observed at IX in the spot-on puppy study 

(one incident ofloose stools on Day 3 and one incident of vomiting after the second dose) in 

conjunction with the reduced exposure to actives, TRB concludes that this study is acceptable to 

support a spray-on use of 2724-797 at an application rate of 8 glkg or lower to puppies of 10 weeks of 

age and older. 

In these reviews, even the most recent, the EPA has not directly addressed the statistical argUTJlfflts 

that were presented in the 8/2412009 rebuttal to the DER (MRID 47835301). Wellmark believ~'3 that 

this is a key issue ~ the basic argument is that the observed "effects" were determined to be n,)~ 

statistically significant in the IX and 3X dose groups (Hansen, 2009). Observations in the 5X group 

occurred at rates similar to adverse events in IX applications of registered prodl,c:ts 1'1 addition', 

potential concerns related to attractiveness to cats appear to be anecdotal, and not legitimate. 

Review of the clinical observations show that in Group A only two females had <;;lil1ir.al signs. {J~c 

with loose stools several days after the first dose, an observation also noted a fe\'/ c<:.ys before 

initiation of test material administration for this animal. And, a single observation of vomit W'l<; 

recorded in one female Day 9. Since both loose stools and vomit are common clinical observations in 

laboratory puppies, the significance of these observations was further investigated. APSS sc:u,t;:,t" 

reviewed the clinical observations reported in the study. The evaluation included statistical analysis of 

the gastrointestinal signs in this study and a review of the incidence of gastrointestinal signs in the 

APSS public adverse reaction database. The statistical evaluation showed that the increase in 

gastrointestinal signs was statistically different from the controls only at the 5X dose and that the 

occurrence of these signs at the 5X dose were similar to what is reported to ASPCA leading to the 

conclusion that (Hansen 2009) "The occurrence of mild gastrointestinal signs following high dose 

(5X) exposure to JM982 spot-on in puppies is similar to reported signs following appropriate use (IX) 

of EPA registered and currently marketed spot-on formulations containing active ingredients other 

than etofenprox". 

Based on analysis of the adverse reaction type and frequency reported to the ASPCA, occasional 

gastrointestinal signs are a common complaint (19.1 % of total) in currently registered products. Since 

statistically significant effects compared to controls occurred only at the 5X level and not at IX or 3X, 

and the effects seen at 5X are similar to current products, it is expected that the product(s) supported 

by this study do have an acceptable margin of safety. 

In summary, in 2009 Wellmark provided (DER) rebuttal arguments to EPA that have not been 

thoroughly evaluated (as far as we understand). In addition, reviews provided by EPA contain 

material (suggestions of potential risk due to lanolinl

) do not appear to be adequately supported. This 

current submission for a label amendment requests re-evaluation of previously submitted data, as well 

as evaluation of a new study which reaches similar conclusions. 

1 In addition, the properties ofraw !anolin may be very different from the properties of the materia! used as an 

inert ingredient in the formula for 2724-796. 

Page 3 of 5 

77
Label Amendment, 2724-796 

Content of This Submission: 

With this proposed label amendment, Wellmark is submitting a review of adverse incident data (Petree 

and McFadden, 2011) for the 2724-796 product; including adverse events due to misapplication to 

puppies. If the EPA's conclusions in DP 360171 (5/22/2009) are correct, adverse events in puppies 

should show an increased rate of incidents with gastrointestinal signs. 

Instead, the review of Adverse Effect Incidents provided with this submission finds that: 

• The distribution of severity of adverse events in puppies (due to misapplication) for the 

etofenprox product was better than for a permethrin product that allows applications to 

puppies. 

• No elevation of digestive system events in puppies was found for the etofenprox product when 

compared to two permethrin dog topicals. 

• Instead, the distribution of mild clinical signs for puppies for the etofenprox product was 

found to be similar (not statistically different from) the distribution of mild clinical signs in 

adult dogs. 

The review of adverse effect incident data shows conclusively that there is no safety hazard assudated 

with the use of the etofenprox topical product on puppies. Even though the current label does not 

permit application to puppies, events due to misapplication provide a more than sufficient foundation 

for analysis. 

Overall, the incident data available to Wellmark International and reviewed in this rcport are t:l~ 

equivalent of a very large scale performance monitoring study. Millions of prodJ.~~ J0ses were sold, 

and even though the total number of applications to puppies is unknown, this analysis represents a 

much larger sample than one could obtain even in any clinical study. 

Notably, the summary conclusion of this analysis of incident data is similar to that reached if! the 

Hansen (2009) report (in MRID 47835301): (1) there is no evidence of a higher frequency of adverse 

events with gastrointestinal signs and (2) the etofenprox product appears to have an acceptable margin 

of safety. In addition, this new analysis documents that the etofenprox spot on has at least three 

significant benefits for the etofenprox spot on product compared to the permethrin product: 

The total rate of adverse incidents was lower 

The rate of incidents in cats was much lower 

The rate of incidents in small dogs « 151bs.) was lower, suggesting that small dogs that were 

particularly sensitive to pennethrin were less sensitive to etofenprox. 

Thus, in addition to documenting that there is an acceptable margin of safety in puppies, the analysis 

of incident data documents that the etofenprox product has an improved safety profile compared to 

permethrin products. Because of this improved safety profile, Wellmark believes that some form of 

label language reflecting these facts should be permitted by EPA, since it is in the best interests of the 

EPA to allow consumers to make an educated choice. (Previous attempts to address this issue have 

been rejected by EPA) 

Specific Changes Proposed in the Label Amendment 

To highlight specific changes proposed in the revised label and provide additional explanation, we 

wanted to note the following specific points in addition to the addition of puppies to the label: 

• Text to comply with Topical Risk Mitigation requirements (as far as we understand) is 

implemented in the revised label. (Age AND weight limitations, for use ONLY on 

Dogs/Puppies, Do not use on cats, etc.) We also include reference to the most prominent 

adverse effect (which is deonal irritation) in the precautionary statements. 

Page 4 of 5 

78
Label Amendment, 2724-796 

• A section on "Use Restrictions" as per the PBO RED DCI has been added, as well as 

modification of reference to PBO in the Ingredient statement. 

• A section of text was added for the text to be included on the individual applicator. 

• One efficacy-related claim was added: "Controls fleas ticks and mosquitoes for up to one 

month". Even though efficacy data does not support a "kills" claim with 90% efficacy for one 

month, the overall effect in some animals in efficacy tests did support control up to one 

month, so, in our view, this claim (while less strong) is supported by the existing efficacy data. 

• Well mark believes the safety of this product for cats is documented in the analysis of adverse 

effect incident data that was included with this submission, and believes that some statement 

acknowledging that record is appropriate for addition to the label, in order to allow customers 

to make an informed choice. While the exact nature of that statement may need to be 

negotiated with the EPA, we are proposing several statements that could reflect the safety 

record that has been documented: 

- Incidental exposure of cats to this product is not likely to cause harmful effects 

- Can be used in households with dogs and cats 

- Based on testing, accidental exposure to cats from this product is not likely to caUSe :,clinus 

harmful effects. 

Please let me know if additional information is needed or there are questions ab,mt lhj~ subMissi('n. 

Regards, 

~~ Sr. Regulatory Project Manager 

Page 5 of 5 

79
TRANSMITTAL DOCUMENT 

1. NAME AND ADDRESS OF SUBMITTER 

Wellrnark International 

1501 E. Woodfield Road 

Suite 200 West 

Schaumburg, IL 60173 

2. REGULATORY ACTION SUPPORTED BY THIS SUBMISSION 

Report Submission to Support Label Amendment to add Use on Puppies to Label 

Product Name, RF2042 [CDSO]; EPA Reg. No. 2724-796 

3. TRANSMITTAL DATE 

June 14,2011 

4. LIST OF DOCUMENTS SUBMITTED 

48511701 1. Petree, L. and McFadden, J. (2011) Analysis of Adverse Effect Incident Data ;or RF204'2 

[CDSO], EPA Reg. No. 2724-796, unpublished, Wellmark International St>ldy No. 4043, 22 pp. 

5. COMPANY NAME 

Wellmark Intemational 

6. COMPANY AGENT 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

1501 E. Woodfield Rd., Suite 200West 

Schaumburg, IL 60173 

7. AGENT SIGNATURE 

? 

~~ DATE, June 14,2011 

8. COMPANY CONTACT: James McFadden PHONE: 847-330-5369 

Page 1 of 1 

80
INVOICE NUMBER INVOICE SAP DOCUMENT NUMBER 

DATE 

PRIA FEE 2724-81~ 04/11/2011 1900138056 

, 

, 

, 

U.S. ENVIRONMENTAL PROTECTIONIOO5118 TOTALS - - -:> 

AGENCY 

Wollmark Inti & Farnam Co's, Inc. 

Contrai Lifo Sciences 

1501 E. Woodfield Rd Suite #200W 

Schaumburg, IL 60173 

PAY *** NINE HUNDRED FOUR USD and 25/100 *** 

TO THE 

ORDER 

OF 

U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

WASHINGTON FINANCE CENTER 

FIFRA SERVICE FEES 

P.O. BOX 979074 

.ST. __ .LOJUS. __ MQ .'_ 6.USn.:".90.0Q._ 

1068403 

GROSS AMOUNT DISCOUNT NET AMOUNT 

904.25 

I 

904.25 

Check Number 

Bank of America 

0.00 904.25 

, 

" . { , 

0.00 904.25 

719 

Bank of America Illinois 

Chicago, Illinois 60697 

CHECK DATE 

04/14/2011 

CHECK AMOUNT

904.25

VOID AFTER 

BY 

". ,nrnl n:::l". 

81 *Commercial/financial information may be entitled to confidential treatment*
",f2164 AfT COMBO 

[Text for "009" must be same size as Brand Name] 

Front Panel ~ For Use Only on Toy [6~12 Ibs.), Small [13-31 Ibs.), Medium [32-55 Ibs.), Large [56 ·80 

Ibs.), and Extra Large [81Ibs. and over) Dogs/Puppies 10 Weeks of age or older 

Front Panel- For Use Only on Dogs/Puppies 10 Weeks of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks of age or older 

General Claims: [Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide jsmailerj weight ranges to improve [maintain][deliver] efficacy 

[performance][fJea and tickllcontroll]protectionj on [for] your dog/puppy 

Effective on indoor and outdoor dogs/puppies 

([1]]3114[[6] monthly treatments) [1113[4116] Months Supply [241148] doses 

Spreads naturally with dog's/puppy's movement (skin and hair oils) 

[Formula][Contains lanolin for coat conditioning] 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

[Fast Acting][Long LastingllKilis Fleas and Ticks by Contact] 

[Fresh][Clean][[ScentIiSmell] 

[Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

[Incidental exposure of cats to this product is not likely to cause harmful effects] 

[Can be used in households with dogs and cats] 

[Based on testing, accidental exposure to cats from this product is not likely to cause serious harmful 

effects.] 

Efficacy Claims: 

Each tube [cartridge][vial]]application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month]]Fourf4 Week [Flea]rrick][Mosquito] Treatment] 

[Controls fleas, ticks and mosquitoes for up to one month] [Monthly treatment for control of fleas, ticks 

and mosquitoes] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hours][Kills more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection [against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes [the major carrier of canine heartworm) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator [IGR) to kill flea eggs and prevent flea developMent for 

[more than 10 weeks] up to [75 days][2.S months]] 

[Breaks Flea Ufe Cycle for [more than 10 weeks] up to [75 days][2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to [75 daYS][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

1 

82
Applicator Claims 

[New] [applicator] 

[New] conlemporary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [liquid][application] get down to [the][your][dog's/puppy's] skin 

ErgonomicalJy contoured [ergonomic][shape][design] for easy handling [ease of use] [easy use] 

For use with [only][brand name][disposable][liquid dispensing] tubes [pods] [vials] [cartridges] 

[brand name] [applicator][has][provides][alJows for][delivers] better grip 

[brand name][provides] re-closable [re-sealable] packaging for [easy] storage 

Closing [the][brand name][applicator] door automatically opens the [disposable][liquid dispensing] tube 

[pod][vial][cartridge] 

[brand name] [Applicator] [will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the [your] dog/puppy 

Includes unique [brand] applicator 

Puts the liquid on your dog/puppy - not your hands 

Directs the liquid onto your dog[lpuppy]- not your hands 

Directs the liquid onto your dog[/puppy]- away from your hands 

Applies liquid to your dog's[/puppy's] skin - not yours 

Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

]Easy to use] Longer applicator tip for easy application to long-haired dogs/puppys 

Thermoform claims 

New 

New ]disposable]Jiquid dispensing] tube [cartridge]]vial][pod] 

(Note tube/vial/cartridge/pod used interchangeably) 

[New] [brand name][disposable][liquid dispensing] [tube][vial][pod] tip [helps][to] spread out liquid [on 

your][dog/puppy] 

Unique [cartridge] [tube][vial][pod] with flow control 

[no drip][no mess][appJication][tube][cartridge]vial][pod] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator][tube][vial[cartridge][pod]][inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with ]brand] applicator 

Applicator [device] not included 

]brand] Refill Pack [brand][applicator [device] not included] 

Refill Claims 

For use [only] with [brand name][Applicator] 

([1][3][4[[6] monthly treatments) [1][3][4][6] Months Supply [24][48] doses 

Easy to use [convenient] refills 

[brand name [e.g., Adams or Bio Spot)] [brand name [e.g., Smart Shield]] [applicator] 

[tube][cartridge][vial][pod]refill pack [refills] 

Refill pack 

New [refill][tube][cartridge][viaJ][pod] design 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

83
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)" ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

"(butyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: One: 0.05 fI oz (1.5 ee) [vial][tube][cartridge] [Toy Dogs]fland Puppies1 

0.10 fl OZ (3.0 ee) [vial1 [tube][eartridge1 (Small Dogs)f[and Puppies] 

0.15 fI oz [4.5 ee) [vial](tube][eartlidge] (Medium Dogs)f[and Puppies] 

0.20 fI oz [6.0 ee) [vial][tube][eartridge] (Large Dogs)f[and Puppies] 

EPA Reg. No. 2724-811 

EPA Est. No. 

0.30 fI oz (9.0 ee) [vial][tube][eartridge] (Extra Large Dogs)[and Puppies] 

[ICON - DO NOT USE ON CATS] 

3 

84
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES. DO 

NOT USE ON OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 NT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog/puppy. 

[brand] provides flea and tick protection for dogs/puppies for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] App!icator is speciaHy designed to make applying flea and tick control easier, more 

precise ~- and neater- than ever before. You simply insert the appropriate [brand] tube 

[via!][cartridge] for your dog/puppy into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design] makes it easy to grip and a built-in fin [tip] [comb] helps to 

spread [part] the [your] dog's/puppy's hair to allow the liquid to more readily [better] reach [apply] the 

[to] [your dog's/puppy's] skin. The tube [via!][cartridge] is sealed inside, so you can be confident that 

the liquid goes onto your dog[/puppy] - and not your hand. Plus, if the applicator is laid down on a 

table, counter or other flat surface, it won't run out or drip. 

DlRECT!ONS FOR USE: !t is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

App!y this product once every 30 days unless a retreatment is necessary. Do not make tnt;; 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 NT COMBO works by application directly to the dog's[/puppy's] skin, no't t(l'the hnir 

When applying, use applicator device tip to push aside dog's[/puppy's] hair to cP-::-VJ direct 

application to the skin. Do not get this product in dog's[lpuppy's] eyes or moutr.. ' , 

[(Note: Application now assumes one tube[vial][cartridge] per dog[/puppy] per application)] 

The RF2164 NT COMBO provides a unique applicator device that allows dog/puppy owner:;; 

to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubes][vials]with 

less mess. 

4 

85
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[DFU Set No. 1J 

FOR [TOy][SMALL][MEDIUMJ SIZE DOGS/PUPPIES 

To apply the [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open [color, e.g. green] door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]white side up into open applicator with front of tube placed under 

tab on door. 

-[To Load, place tube [cartridge][vial] white side up into the[open] applicator with tip end of tube 

placed under the [color][U-shaped] tab on door] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Gently close the [color, e.g. green] door [and] the tube will snap open. 

4. APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on [color-green] door 

[number-once] at each of [two] (Toy Dogs/Puppies) [three] (Small Dogs/Puppies) (Medium 

Dogs/Puppies) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 AfT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5. DISPOSE [icon] 

[When finished, hold applicator device over trash.] To dispose of empty tube, open [color, e.g. green] 

door and drop empty tube into trash or offer for recycling if available. [Close applicator device door 

and store in original package.] 

6. USE RESTRICTIONS: (2 alt. statements) 

- Do not reapply product for 30 days unless re-treatment is required, but not sooner than ts'days after 

the initial treatment. Do not retreat more than once per month. 

- If necessary, product can be reapplied, but not sooner than 8 days after the initial;treatr'lcrit. Do not 

retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applicatioi13J 

5 

86
FOR [LARGE][EXTRA LARl j DOGS/PUPPIES 

1 

2 

3 

4 APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door 

[number-once] at each of four or five evenly placed spots between the shoulder to the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that CQuid cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 AfT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5 

6 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

RF2164 NT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skin 

disorder known as flea allergy dermatitis (FAD). Treatment of dogs/puppies with RF2164 NT 

COMBO rapidly kills fleas and may reduce the incidence of this condition.] [RF2164 AfT 

COMBO is water resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosaqe: 1 icartridQe (ube]ivia!] every 30 days per dog!!puppy] 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 1 ") (30 Days From 2"') 

Reminder: I purchased RF2164 AIT COMBO from: 

NOTES_==:-====::o Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children' 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse cartridge {viaf] 

{tube]. Place in trash or offer for recycling if available. If partially filled: cal: yo';Jr'local ,'5olid 

waste agency for disposal instructions. Never place unused product down any, jrvj00r or 

outdoor drain. 

6 

87
PRECAUTIONARY STATEM. ,TS 

HAZAROS TO HUMANS ANO OOMESTIC ANIMALS - CAUTION 

00 NOT USE ON DOGS/PUPPIES lESS THAN 10 WEEKS OLD. For external use only. Causes 

moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your dog with mild soap and rinse 

with large amounts afwater. If signs continue, consult a veterinarian immediately. 

Some dogs may experience hair loss or temporary skin irritation at the application site. If signs 

persist or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present. after first 5 minutes, then continue rinsing 

• Call a Doison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

infonnation. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, sellers liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

fURL] 

Made in USA 

7 

88
TEXT FOR LIQUID TUBE/C, fRlDGEIVIAL 

Product name 

Etofenprox 30%, (S}~Methoprene 3.6%, Piperonyf Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS) 

For Use Only on Toy (6~12 Ibs.), Small (13~31 Ibs.), Medium (32·S5Ibs.), Large (56 ·80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot·On Flea & Tick Control for Dogs/Puppies 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)" ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

"(butyl carbityl) (6·propylpiperonyl ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows} 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this produ,::.t 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid c::trtrid;je 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube fcartridgeJ[vial] from the package and insert into opene::l rt.land name}' 

applicator device. Make application according to label directions supplied with thE: -ibrand 

name] applicator device. If you need directions for application, please call1-BOO-XXX-XXX)<. 

(Precautionary and Storage/Disposal) text included) 

Wellrnark International 

1501 East Woodfield Road 200W 

Schaumburg, illinois 60173 

8 

89
Icon Set for the RF2164 AfT COMBO 

[ICON SET 1] 

Directions for Use 

For Moxilnl D:gs (32 -55 Ibs) 

To apply the treatment, use applicator device with ONLY 

ONE liquid tube per application / per dog 

Use scoop to lift: OPEN green door 

.' , ' 

To LOAD place tube WHITE side UP 

into applicator with tip end of tube 

placed under tab on door 

Gently CLOSE the door 

and the tube will snap open. 

To APPLY Use tip to part fur 

and get next to dog's skin. 

-Press circle on green door 

at 3 spots between 

-=~~~ders and tail 

("#Spots" is a variable dependent on size of dog) 

9 

90
KF2164 AIT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Pane! - For Use Only on Toy (6-12 Ibs.), Small (13-31Ibs.), Medium [32-55Ibs.), Large [56 -80 

Ibs.), and Extra Large (81 lbs. and over) Dogs/Puppies 10 Weeks of age or older 

Front Panel- For Use Only on Dogs/Puppies 10 Weeks of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks of age or older 

General Claims: [Note that claims previously approved for RF2042 COSO, 2724-796, are in black text} 

5 size categories provide [smaller] weight ranges to improve [maintain][deliver] efficacy 

[performance][flea and tick][control][protection] on [for] your dog/puppy 

Effective on indoor and outdoor dogs/puppies 

([1][3][4[[6J monthly treatments) [1J[3][4][6] Months Supply [24J[48J doses 

Spreads naturally with dog's/puppy's movement (skin and hair oils) 

[Formula][Contains lanolin for coat conditioning] 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

[Fast Acting][Long Lasting][Kilis Fleas and Ticks by Contact] 

[Fresh][Clean]OScent][Smell] 

[Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

[Incidental exposure of cats to this product is not likely to cause harmful effects] 

[Can be used in households with dogs and cats] 

[Based on testing, accidental exposure to cats from this product is not likely to cause serious harmful 

effects.] 

Efficacy Claims: 

Each tube [cartridge][vial] [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month][Four/4 Week [Flea][Tick]]Mosquito] Treatment] 

[Controls fleas, ticks and mosquitoes for up to one month] [Monthly treatment for control of fleas, ticks 

and mosquitoes] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hours][Kills more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease ' " , 

Kills and Repels mosquitoes (the major carrier of canine heartworm) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to ]75 days][2.5 months]] 

[Breaks Flea Life Cycle for [more than 10 weeks] up to [75 days][2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

1 

91
Applicator Claims 

[New] [applicator] 

[New] contem porary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [liquid][application] get down to [the]]your][dog's/puppy's] skin 

Ergonomically contoured [ergonomic[[shape][design] for easy handling [ease of use] ]easy use] 

For use with [only][brand name][disposable][liquid dispensing] tubes [pods] [vials] ]cartridges] 

[brand name] [applicator][has][provides][allows for][delivers] better grip 

[brand name][provides] re-closable [re-sealable] packaging for ]easy] storage 

Closing [the][brand name][applicator] door automatically opens the [disposable]]liquid dispensing] tube 

[pod][vial][cartridge] 

[brand name] [Applicator] [will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the ]your] dog/puppy 

Includes unique [brand] applicator 

Puts the liquid on your dog/puppy- not your hands 

Directs the liquid onto your dog[/puppy] - not your hands 

Directs the liquid onto your dog[lpuppy]- away from your hands 

Applies liquid to your dog's[/puppy's] skin - not yours 

Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs/puppys 

Thermoform claims 

New 

New [disposable][liquid dispensing] tube [cartridge][vial][pod] 

(Note tube/vialicartridge/pod used interchangeably) 

[New] [brand name]]disposable]liquid dispensing] ]tube][vial][pod] tip [helps][to] spread out liquid [on 

your][dog/puppy] 

Unique [cartridge] [tube]]vial][pod] with flow control 

[no drip][no mess][application][tube][cartridge][vial][pod] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator]]tube][vial[cartridge][pod]]inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

[brand] Refill Pack [brand][applicator [device] not included] 

Refill Claims 

For use [only] with [brand name[[Applicator] 

([1 [[3][4][6] monthly treatments) [1]]3]4]]6] Months Supply [24][48] doses 

Easy to use [convenient] refills 

[brand name (e.g., Adams or 8io Spot)] [brand name (e.g., Smart Shield)] [applicator] 

[tube] [cartridge] [vial] [pod] refill pack [refills] 

Refill pack 

New [refill][tube][cartridge][vialJ]pod] design 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

92
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Sutoxide (CAS # 51-03-6), ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*(buty! earbity!) (S-propy!piperony! ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: One: 0.05 fI oz (1.5 ee) [viaij[tubelleartridge] [Toy Dogs)f[and Puppies] 

0.10 fl OZ (3.0 ee) [via!] [tube][eartridge] [Sma!! Dogs)~and Puppies] 

0.15 fI oz (4.5 ee) [via!][tube][eartridge] (Medium Dogs)/[and Puppies] 

0.20 fI oz (S.O ee) ]via!][tubelleartridge] {Large Dogs)~and Puppies] 

EPA Reg. No. 2724-811 

EPA Est. No. 

0.30 fI oz (9.0 ee) [via!][tube][eartridge] (Extra Large Dogs)]and Puppies] 

[ICON - DO NOT USE ON CATS] 

3 

93
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES. DO 

NOT USE ON OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AfT COMBO] prevenls flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog/puppy. 

[brand] provides flea and tick protection for dogs/puppies for up to 30~days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that CQuid hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier, more 

precise ~- and neater- than ever before. You simply insert the appropriate [brand] tube 

[vial][cartridge] for your dog/puppy into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design] makes it easy to grip and a built~in fin [tip] [comb] helps to 

spread [part] the [your] dog·s/puppy's hair to allow the liquid to more readily [better] reach [apply] the 

[to] [your dog's/puppy's] skin. The tube [vial][cartridge] is sealed inside, so you can be confident that 

the liquid goes onto your dog[/puppy] - and not your hand. Plus, if the applicator is laid down on a 

table, counter or other flat surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this prodJ'ct 

label. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make:!h-; 

retreatment sooner than 8 days after the initial treatment. Do not retreat more !Ii~m once per 

month. 

RF2164 AfT COMBO works by application directly to the dog's[/puppy's] skin, not to the i)air .. 

When applying, use applicator device tip to push aside dog's[!puppy's] hair to allow direGt 

application to the skin. Do not get this product in dog's[/puppy's] eyes or mouth. 

[(Note: Application now assumes one tube[vial][cartridge] per dog[/puppy] per application)] 

The RF2164 AIT COMBO provides a unique applicator device that allows dog/puppy owners 

to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubes][vials]with 

less mess. 

4 

94
[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications[ 

[DFU Set No.1] 

FOR [TOy][SMALL][MEDIUM] SIZE DOGS/PUPPIES 

To apply the [RF2164 AfT COMB01 treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open [color, e.g. green] door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vialjwhite side up into open applicator with front of tube placed under 

tab on door. 

-[To Load, place tube [cartridge][vial] white side up into the[open] applicator with tip end of tube 

placed under the [color][U-shaped] tab on door] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Gently close the [color, e.g. green] door [and] the tube will snap open. 

4. APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on [color-green] door 

[number-once] at each of [two] (Toy Dogs/Puppies) [three] (Small Dogs/Puppies) (Medium 

Dogs/Puppies) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 NT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy. brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5. DISPOSE [icon] 

[When finished, hold applicator device over trash.] To dispose of empty tube, open [color', 'e.g'. green] 

door and drop empty tube into trash or offer for recycling if available. [Close applicator ~evice door 

and store in original package.] 

6. USE RESTRICTIONS: (2 alt. statements) 

- Do not reapply product for 30 days unless re-treatment is required, but not '$(iOrler than 8 days after 

the initial treatment. Do not retreat more than once per month. 

- If necessary, product can be reapplied, but not sooner than 8 days after the initial treatment. Do not 

retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

5 

95
FOR [LARGE][EXTRA LARG ,DOGS/PUPPIES 

1 

2 

3 

4 APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door 

[number-once] at each of four or five evenly placed spots between the shoulder to the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 AIT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

S 

6 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

RF2164 AIT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skin 

disorder known as flea anergy dermatitis (FAD). Treatment of dogs/puppies with RF2164 AIT 

COMBO rapidly kills fleas and may reduce the incidence of this condition.] [RF2164 A.IT 

COMBO is water resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosaqe: 1 rcartridGe tub·~ilvi~·11 every 30 davs oer doqrlouoovl 

Pet's Name First Treatment Date se~ond Treatment ~~te T(~ird Treatment Dn~~e 30 Davs From 1 st 30 Davs From 2nd 

Reminder. I purchased RF2164 AfT COMBO from: _______ _ 

NOTES: 

Treatme:cn"Ct "ta"b"leccc"a"n-;:bC"eCCe"x"C:pa=-n"'ded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse car'ti-id~e; [via~ 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call you!'" h'\{,:al soad 

waste agency for disposal instructions. Never place unused product down any indc:r or 

outdoor drain. 

6 

96
PRECAUTIONARY STATEMc . rs 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS/PUPPIES LESS THAN 10 WEEKS OLD. For external use only. Causes 

moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your dog with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some dogs may experience hair loss or temporary skin irritation at the application site. If signs 

persist or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Cal! a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark Intemational 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URLJ 

Made in USA 

7 

97
TEXT FOR LIQUID TUBE/C, ,HIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6~12Ibs,), Small (13-31 Ibs.), Medium (32-55 Ibs.). Large (56 -80 Ibs.), and 

Extra Large (81Ibs. and over) Dogs 6 months of age or older 

[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs/Puppies 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

~(buty! carbityl) (6-propylpiperonyl elher) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid cartr;n!J~ 

[tube][vial][for each application1 with the applicator device. 

Remove one refill tube [cartridgeJ[vial} from the package and insert into opened [brand name} 

applicator device. Make application according to label directions supplied with the [brand 

name} applicator device. If you need directions for application, please call1-BOO-XXX-XXXX. 

(Precautionary and Storage/Disposal) text included) 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

8 

98
Icon Set for the RF2164 AlT COMBO 

[ICON SET 1J 

Directions for Use 

For Maim D::gs (32 -55 Ibs) 

To apply the treatment, use applicator device with ONLY 

ONE liquid tube per application I per dog 

Use . scoop to lift OPEN green door 

To LOAD place tube WHITE side UP 

into applicator with tip end of tube 

placed under on door 

Gently CLOSE the door 

and the tube will snap open. 

To APPLY Use tip to part fur 

and get next to dog's skin. 

Press circle on green door 

at 3 spots between 

~!lS~ldE'rs and tail 

("#Spots" is a variable dependent on size of dog) 

9 

99
r<F2164 AlT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Pane! ~ For Use Only on Toy (6-12 !bs.), Small ]13-31Ibs.), Medium ]32-55Ibs.), Large ]56 -80 

Ibs.), and Extra Large ]81Ibs. and over) Dogs/Puppies 10 Weeks of age or older 

Front Panel. For Use Only on Dogs/Puppies 10 Weeks of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks of age or older 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide ]smaller] weight ranges to improve ]maintainlldeliver] efficacy 

[performance]]f1ea and tickllcontrol][protection] on lfor] your dog/puppy 

Effective on indoor and outdoor dogs/puppies 

01J[3][406J monthly treatments) J1J[3Jl4][6J Months Supply [24]]48J doses 

Spreads naturally with dog's/puppy's movement (skin and hair oils) 

]FormulallContains lanolin for coat conditioning] 

[Water Resistant] [to keep kiUing fleas and ticks in humid and wet conditions] 

[Fast Acting][Long Lasting][Kills Fleas and Ticks by Contact] 

[FreshllClean]]]Scent][SmeU] 

]Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

]Patent Pending] 

]Incidental exposure of cats to this product is not likely to cause harmful effects] 

[Can be used in households with dogs and cats] 

[Based on testing, accidental exposure to cats from this product is not likely to cause serious harmful 

effects.] 

Efficacy Claims: 

Each tube ]cartridgellvial] [application] [kiUs fleas & ticks for 3 weeks] and ]kiUs and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month][Four/4 Week [Flea][Tick][Mosquilo] Treatmenij 

]Controls fleas, ticks and mosquitoes for up to one month] ]Monthly treatment for control of fleas, ticks 

and mosquitoes] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[KiUs 85% of ticks within 48 hours][Kills more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] ]Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes ]the major carrier of canine heartworm) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development -!'or 

[more than 10 weeks] up to]75 daYS]]2.5 months]] - -

[Breaks Flea Life Cycle for]more than 10 weeks] up to [75 days][2.5 months] 

]Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

1 

100
Applicator Claims 

[New] [applicator] 

[New] contemporary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [Iiquid][application] get down to [the][your][dog's/puppy's] skin 

Ergonomically contoured [ergonomic][shape][design] for easy handling [ease of use] [easy use] 

For use with [only][brand nameEdisposableEliquid dispensing] tubes [pods] [vials] [cartridges] 

[brand name] [applicator][has][providesEaliows for][delivers] better grip 

[brand name][provides] re-closable ]re-sealable] packaging for [easy] storage 

Closing [the][brand name][applicator] door automatically opens the [disposable][liquid dispensing] tube 

[podll vialll ca rtridge] 

[brand name] [Applicator] [will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the [your] dog/puppy 

Includes unique [brand] applicator 

Puts the liquid on your dog/puppy - not your hands 

Directs the liquid onto your dog[/puppy] - not your hands 

Directs the liquid onto your dog[/puppy] - away from your hands 

Applies liquid to your dog's[/puppy's] skin - not yours 

Helps prevent applying the wrong spot-on [dose] [product] on ]to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs/puppys 

Thermoform claims 

New 

New [disposable][liquid dispensing] tube [cartridge][vial][pod] 

(Note tube!vial/cartridge/pod used interchangeably) 

[New] [brand name][disposableEliquid dispensing] [tube][vial][pod] tip [helps][to] spread out liquid [on 

yourlldog/puppy] 

Unique [cartridge] [tube][vial][pod] with flow control 

] no drip][no mess][ application][tube][cartridge][vial][pod] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicatorEtube][vial[cartridge][pod]][inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

[brand] Refill Pack [brand][applicator [device] not included] 

Refill Claims 

For use [only] with [brand name][Applicator] 

([1113114[[6] monthly treatments) [1113114][6] Months Supply [241148] doses 

Easy to use [convenient] refills 

[brand name (e.g., Adams or Bio Spot)] [brand name [e.g., Smart Shield]] [applicator] 

[tube] [cartridge] [via I]] pod]refill pack [refills] 

Refill pack 

New [refill][tube][cartridge][vial][pod] design 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

101
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)< ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*(butyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fl 02 11.5 ce) Ivialijtubel(eartridgej (Toy Dogs)/Iand Puppiesl 

0.10 fI OZ (3.0 ee) (viall (tubeijcartridgel (Small Dogs)/[and Puppiesl 

0.15 fl 02 (4.5 ee) Iviailltubeijcartridgej (Medium Dogs)/(and Puppiesl 

0.20 fI 02 (6.0 ee) Ivialijtubeijeartridgel (large Dogs)/(and Puppiesl 

0.30 fI 02 (9.0 ee) Ivialijtube![eartridgellExtra large Dogs)land Puppiesl 

[ICON - DO NOT USE ON CATS] 

3 

102
RF2164 AiT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES. DO 

NOT USE ON OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 NT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 NT COMBO also kills fieas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog/puppy. 

[brand] provides flea and tick protection for dogs/puppies for up to 30~days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier, more 

precise -- and neater - than ever before. You simply insert the appropriate [brand] tube 

[vial][cartridge] for your dog/puppy into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design] makes it easy to grip and a built-in fin [tip] [comb] helps to 

spread [part] the [your] dog's/puppy's hair to allow the liquid to more readily [better] reach (apply] the 

[to] [your dog's/puppys] skin. The tube [vial][cartridge] is sealed inside, so you can be confident that 

the liquid goes onto your dog[lpuppy] - and not your hand. Plus, if the applicator is laid down on a 

table, counter or other flat surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. .. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Dc ,~:t r.1ake the 

retreatment sooner than 8 days after the initial treatment. Do not retreat mor.J thar, onc~ t>er 

month. 

RF2164 NT COMBO works by application directly to the dog's~puppy's] skin. n.0t to the hair. 

When applying, use applicator device tip to push aside dog's[/puppys] hair to allow direct 

application to the skin. Do not get this product in dog's[lpuppy's] eyes or mouth. 

[(Note: Application now assumes one tube[vial][cartridge] per dog[/puppy] per applicatior·)J 

The RF2164 AfT COMBO provides a unique applicator device that allows dog/puppy owners 

to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubes][vials]with 

less mess. 

4 

103
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[DFU Set NO.1] 

FOR [TOY)[SMALL)[MEDIUM] SIZE DOGS/PUPPIES 

To apply the [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open [color, e.g. green] door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]white side up into open applicator with front of tube placed under 

tab on door. 

-[To Load, place tube [cartridge][vial] white side up into the[open] applicator with tip end of tube 

placed under the [color][U-shaped] tab on door] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Gently close the [color, e.g. green] door [and] the tube will snap open. 

4. APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on [color -green] door 

[number -once] at each of [two] (Toy Dogs/Puppies) [three] (Small Dogs/Puppies) (Medium 

Dogs/Puppies) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 NT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5. DISPOSE [icon] 

[When finished, hold applicator device over trash.] To dispose of empty tube, open [color, E::.':;j., green] 

door and drop empty tube into trash or offer for recycling if available. [Close applicator device door 

and store in original package.] , 

6. USE RESTRICTIONS: (2 alt. statements) 

- Do not reapply product for 30 days unless re-treatment is required, but not s,).:.rl€,r than 8 daiS after 

the initial treatment. Do not retreat more than once per month. 

- If necessary, product can be reapplied, but not sooner than 8 days after the initial treatmo;,~.· Do not 

retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

5 

104
FOR [LARGE][EXTRA LARL _1 DOGS/PUPPIES 

1 

2 

3 

4 APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door 

[number~once] at each of four or five evenly placed spots between the shoulder to the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 Aff COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5 

6 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

RF2164 AJT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skin 

disorder known as flea allergy dennatitis (FAD). Treatment of dogs/puppies with RF2164 AJT 

COMBO rapidly kills fleas and may reduce the incidence of this condition.] [RF2164 AfT 

COMBO is water resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosage: 1 [cartridge lubelfvial1 eve", 30 davs Der doar/DUDDvl 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 151) (30 Davs From 2nd

) 

Reminder. I purchased RF2164 AiT COMBO from. _______ _ 

NOTES.:_~~ __ ~ __ ~ 

Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from child(l~q 

and animals. Uquid Cartridge [vial][tube] Disposal: If empty: Do not reuse c<?rtri':ige [vial] 

[tube]. Place in trash or offer for recycling if available. If partially fiJled: Ca:1 your locat ~oli{L 

waste agency for disposal instructions. Never place unused product down arlY ;rlui lor or 

outdoor drain. 

6 

105
PRECAUTIONARY STATE~ .. iTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS/PUPPIES LESS THAN 10 WEEKS OLD. For external use only. Causes 

moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your dog with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some dogs may experience hair loss or temporary skin irritation at the application site. If signs 

persist or become more severe, contact veterinarian immediately and report incident to company at 

1-800-)()(X-XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark Intemational 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URLJ 

Made in USA 

7 

106
TEXT FOR LIQUID TUBE/C, . TRIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12 Ibs.). Small (13-31 Ibs.), Medium (32-55Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquitolrrreatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs/Puppies 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)* ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*{butyl carbityJ} (6-propylpiperonyJ ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid cart'ricge 

[tube][viaIUfor each application1 with the applicator device. 

Remove one refill tube [cartridge][vial] from the package and insert into opene~:Hbrdnd namA] 

applicator device. Make application according to label directions supplied with the [branc 

name] applicator device. If you need directions for application, please call1-BOD-XXX-.>e6o<: 

(Precautionary and StoragelDisposal) text included) 

Wellmark Intemational 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

8 

107
Icon Set for the RF2164 AfT COMBO 

[ICON SET 1] 

Directions for Use 

For MEditm D:gs (32 -55 Ibs) 

To apply the treatment, use applicator device with ONLY 

ONE liquid tube per application I per dog 

Use ,scoop to lift OPEN green door 

To LOAD place tube WHITE side UP 

into applicator with tip end of tube 

placed under tab on door 

Gently CLOSE the door 

and the tube will snap open, 

To APPLY Use tip to part fur 

and get next to dog's skin, 

Press circle on green door 

at 3 spots between 

~~~IdE>rS and tail 

("#5pots" is a variable dependent on size of dog) 

9 

108
KF2164 AIT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Panel- For Use Only on Toy (6-12 lbs.], Small (13-311bs.], Medium (32-551bs.], Large (56 -80 

Ibs.], and Extra Large (81 Ibs. and over] Dogs/Puppies 10 Weeks of age or older 

Front Pane! - For Use Only on DogslPuppies 10 Weeks of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control1 

Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks of age or older 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide [smaller] weight ranges to improve [maintain][deliver] efficacy 

[performance][f1ea and tick]control][protectionj on ]for] your doglpuppy 

Effective on indoor and outdoor dogs/puppies 

([1113114116] monthly treatments] [1113114][6] Months Supply [24][48] doses 

Spreads naturally with dog's/puppy's movement (skin and hair oils] 

[Formula][Contains lanolin for coat conditioning] 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions] 

]Fast Acting][Long Lasting][Kilis Fleas and Ticks by Contact] 

] Fres h lIelea n ][[Scen tl Smell] 

[Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

[Incidental exposure of cats to this product is not likely to cause harmful effects] 

[Can be used in households with dogs and cats] 

[Based on testing, accidental exposure to cats from this product is not likely to cause serious harmful 

effects.] 

Efficacy Claims: 

Each tube ]cartridge][viaG [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month]]Four/4 Week [Flea][Tick]]Mosquito] Treatment] 

[Controls fleas, ticks and mosquitoes for up to one month] [Monthly treatment for control of fleas, ticks 

and mosquitoes] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hours][Kilis more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] ]Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm] 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR] to kill flea eggs and prevent flea developrnert for 

[more than 10 weeks] up to [75 days][2.5 months]] 

[Breaks Flea Life Cycle for [more than 10 weeks] up to [75 days][2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

1 

109
Applicator Claims 

[New] [applicator] 

] New] contemporary design 

]brand name] [Applicator] helps to prevent getting liquid on ]your] hands 

]brand name] [Applicator] tip parts hair to help [liquid]] application] get down to lthe][your][dog's/puppy's] skin 

Ergonomically contoured [ergonomicllshape]]design] for easy handling lease of use] [easy use] 

For use with ]only]]brand name][disposable][liquid dispensing] tubes [pods] [vials] [cartridges] 

[brand name] [applicator][has][provides][allows for][delivers] better grip 

]brand name][provides] re-closable ]re-sealable] packaging for ]easy] storage 

Closing [the]]brand name][applicator] door automatically opens the ]disposable][liquid dispensing] tube 

[pod][vi al][ cartridge] 

[brand name]]Applicator] [will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the ]your] dog/puppy 

Includes unique [brand] applicator 

Puts the liquid on your dogJpuppy- not your hands 

Directs the liquid onto your dog]/puppy]- not your hands 

Directs the liquid onto your dog]/puppy]- away from your hands 

Applies liquid to your dog's[/puppy's] skin - not yours 

Helps prevent applying the wrong spot-on [dose] ]product] on [to] the wrong pet 

Convenient, easy to use ACCU-TIP ]Applicator] ]DISPENSER] 

[Easy to use] Longer applicator tip for easy application to long-haired dogs/puppys 

Thennoform claims 

New 

New [disposable]]liquid dispensing] tube [cartridgej[vial]]pod] 

(Note tube/vial/cartridge/pod used interchangeably) 

]New]]brand name][disposable][liquid dispensing]]tube]]vial]]pod] tip [helps][to] spread out liquid Jon 

your][dog/puppy] 

Unique [cartridge] [tube]]vial][pod] with flow control 

[no drip][no mess]] application]]tube][cartridge][vial][pod] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free ]applicator][tube][vial[cartridge][pod]][inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

[brand] Refill Pack] brandj[applicator [device] not included] 

Refill Claims 

For use [only] with [brand name]Applicator] 

a 1]]3][4][6] monthly treatments) [113]]4]]6] Months Supply [24][48] doses 

Easy to use [convenient] refills 

[brand name (e.g., Adams or 8io Spotll] brand name ]e.g., Smart Shield)] [applicator] 

[tubell cartridge] [viall] pod]refill pack] refills] 

Refill pack 

New ]refill][tube][cartridgellvial][pod] design 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

110
Thermoform name options {tube. cartridge and vial are used in the text} 

Ampoule 

Cartridge 

Packet 

Pod 

Refi!! 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)" ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

~(butyl earbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fI oz (1.5 ee) Iviailltubej[eariridge[ {Toy Dogs)f[and Puppies[ 

0.10 fI OZ (3.0 ee) [viall [tube[eartridge[ {Small Dogs)f[and Puppies[ 

0.15 fI oz (4.5 ee) IviaIUtube[eartridge[ {Medium Dogs)f[and Puppiesl 

0.20 fI oz (6.0 ee) [vial[tube][eartridge] (Large Dogs)f[and Puppies[ 

0.30 fI oz (g.O ee) [vial[tube][eartridge] {Extra large Dogs)[and Puppies[ 

[ICON - DO NOT USE ON CATS] 

3 

111
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES. DO 

NOT USE ON OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AIT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AIT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.} 

Effective flea & tick control for your dog/puppy. 

[brand} provides flea and tick protection for dogs/puppies for up to 30-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand} Applicator is specially designed to make applying flea and tick control easier, more 

precise ~- and neater- than ever before. You simply insert the appropriate [brand} tube 

[viaIHcartridge} for your dog/puppy into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design} makes it easy to grip and a built~in fin [tip} [comb} helps to 

spread [part] the [your] dog's/puppy's hair to allow the liquid to more readily [better] reach [apply] the 

[to} [your dog's/puppy's} skin. The tube [viaIHcartridge} is sealed inside, so you can be confident that 

the liquid goes onto your dog[/puppy}- and not your hand. Plus, if the applicator is laid down on a 

table, counter or other flat surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do ricA !nake the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more ,th~~ onc~, rN 

month. 

RF2164 AIT COMBO works by application directly to the dog's[/puppy's] skin. cet to the hai,. 

When applying, use applicator device tip to push aside dog's[lpuppy's} hair to allow direct 

application to the skin. Do not get this product in dog's[/puppy's} eyes or mouth. 

[(Note: Application now assumes one tube[viaIHcartridge} per doge/puppy} per application)} 

The RF2164 AfT COMBO provides a unique applicator device that allows dog/puppy owners 

to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubes}[vials}with 

less mess. 

4 

112
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[DFU Set No.1] 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS/PUPPIES 

To apply the [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge 

[tubeHvial][for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open [color, e.g. green] door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]white side up into open applicator with front of tube placed under 

tab on door. 

-[To Load, place tube [cartridge][vial] white side up into the [open] applicator with tip end of tube 

placed under the [color][U-shaped] tab on door] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Gently close the [color, e.g. green] door [and] the tube will snap open. 

4. APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicator][tip] to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on [color-green] door 

[number-once] at each of [two] (Toy Dogs/Puppies) [three] (Small Dogs/Puppies) (Medium 

Dogs/Puppies) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 NT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

5. DISPOSE [icon] 

[When finished, hold applicator device over trash.] To dispose of empty tube, open [colo:-, e.g.: green] 

door and drop empty tube into trash or offer for recycling if available. [Close ,aqplicator device door 

and store in original package.] 

6. USE RESTRICTIONS: (2 alt. statements) 

- Do not reapply product for 30 days unless re-treatment is required, but not sohns" than 8 days after 

the initial treatment. Do not retreat more than once per month. 

- If necessary, product can be reapplied, but not sooner than 8 days after the initial treat/Cierlt. Do not 

retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

5 

113
FOR [LARGE][EXTRA LARL -J DOGS/PUPPIES 

1 

2 

3 

4 APPLY [icon] 

The dog/puppy should be standing for easy application. To apply, use [front edge of applicatorJ[tipl to 

part hair and get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door 

[number-oncel at each of four or five evenly placed spots between the shoulder to the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that CQuid cause some of the 

solution to run off the side of the dog/puppy. Do not spread RF2164 AJT COMBO by hand over the 

dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distribute the application over 

the entire dog/puppy, brushing the dog/puppy 12-24 hours after treatment will help to distribute the 

material over the skin. 

S 

6 

[Note: Each package contains sufficient cartridges/tubes/vials for [X1 applications] 

RF2164 AfT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name 1 products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skin 

disorder known as flea allergy dennatitis (FAD). Treatment of dogs/puppies with RF2164 AfT 

COMBO rapidly kills fleas and may reduce the incidence of this condition.1 [RF2164 AfT 

COMBO is water resistant and remains efficacious following exposure to rainfall or swimming.1 

TREATMENT SCHEDULE 

Dosaae: 1 rcartrldae tUbeifviaJl everv 30 davs per dool/puppvi 

Pet's Name First Treatment Date se~ond Treatment Date Tnird Treatment Dn~~e 

30 Davs From 1 SI) 30 Davs From 2nd 

Reminder: I purchased RF2164 AfT COMBO from: .. 

NOTES. 

Treatme·c

n

7

t "ta"b"le-c"a"n-cb-=e-:::eCCx"paCCn:Cded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from child:-o~ 

and animals. Liquid Cartridge [vial][tube1 Disposal: If empty: Do not reuse cartridge [vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solie 

waste agency for disposal instructions. Never place unused product down ar:y :r:coor or 

outdoor drain. 

6 

114
PRECAUTIONARY STATE~ .. lIS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS· CAUTION 

DO NOT USE ON DOGS/PUPPIES LESS THAN 10 WEEKS OLD. For external use only. Causes 

moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your dog with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some dogs may experience hair loss or temporary skin irritation at the application site. If signs 

persist or become more severe, contact veterinarian immediately and report incident to company at 

1·S00·XXX·XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1·S00·)()()(·XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product infonnation, cal! 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Well mark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URLJ 

Made in USA 

7 

115
TEXT FOR LIQUID TUBE/C .. TRIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12 Ibs.), Small (13-31 Ibs.), Medium (32-55 Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control} 

Spot-On Flea & Tick Control for Dogs/Puppies 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1 ) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6,. ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

"'(butyl carbityl) (6-propylpiperonyl ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions :::. tl":i3 produc~ 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube [cartridge][vial] from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device. If you need directions for application, please call1-BOO-XXX-XXXX. 

(Precautionary and Storage/Disposal) text included) 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

8 

116
Icon Set for the RF2164 AfT COMBO 

[ICON SET 1] 

Directions for Use 

For ~ D:gs (32 -55 Ibs) 

To apply the treatment, use applicator device with ONLY 

ONE liquid tube per application I per dog 

Use to lift OPEN green door 

", ' 

To LOAD place tube WHITE side UP 

into applicator with tip end of tube 

placed under on door 

Gently CLOSE the door 

and the tube will snap open. 

To APPLY Use tip to part fUr 

and get next to dog's skin. 

Press circle on green door 

at 3 spots between 

"'::~~IdE'rs and tail 

("#Spots" is a variable dependent on size of dog) 

9 

117
Wellmark 

April 11, 2011 

W(!llmgrk', rngtiongl 

1501 East Woadlleld Road, SU1te 200 West 

Schaumburg, Illinois 60173 

8473305300 

Www,vlellmarkintmnatlonal cam 

Document Processing Desk (FPL) 

Office of Pesticide Programs 7504P 

U.S. Environmental Protection Agency 

Room S-4900 One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202-4501 

ATTENTION: Richard Gebken, PM 10 

SUBJECT: SUBMISSION OF FINAL PRINTED LABELING FOR RF2164 AfT COMBO 

EPA REG. NO. 2724-811 

PER MARCH 9, 2011 EPA STAMPED APPROVED LABEL COMMENTS 

Dear Mr. Gebken: 

Enclosed is a completed EPA Form 8570-1 and 2 copies of final printed labeling incorporating the 

comment changes noted in the 3/9/11 EPA label approvalleUer. Additionally, enclosed is one 

highlighted label with a cover sheet indicating the revisions that were made (red is added text, blue 

strikethrough is deleted text). 

Please call me at 847-330-5376 if you have any questions regarding this submission. Thank you for 

your assistance on this action. 

Yours sincerely, 

WELLMARK INTERNATIONAL 

'1.cvn~ J4huUJ.!. 

Nancy Huebl 

Senior Registration Specialist 

enclosure 

118
--, H nsttuctlons on reverse recomp '''''' " ' .~. F 0= • _rov eel OMS N o. 2O'1O-oOOGO Appr ,,... ova exp res " 

';n~ed statoo 

~ . legist ration cpp ldenlifier Number 

ft EPA Environmental Protection Agency Amendment 'C"", Wuhington, DC 20460 other 

A lication for Pesticide - Section I 

1. CompanyJProduct Number 2. EPA Product Mlnager 3. Pm\>OII$d ClassiflCiIlion 

Wellmark Inlernatiooa!J2724-811 Richard Gebken 

4.ComponylProduct (Name) PM' ~None o Roolficted 

Wellmark IntemationallRF2164 AfT Combo 10 

5. Name and Address of Applicant f Regi&trani (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3) 

Wellmark International (b)(~, my product is similar or identical in composition and labeling to: 

1501 East Woodfield Road, Stlite 200W EPA Reg. No. 

Schaumburg, Illinois 60173 

Product Name 

D Chtx:k if this Is a new at:1I:1root; 

Section -II 

D Amondment - Explain below. o Final printod Iabols in response 10 

Agency leltor dated March9,2011 

o RasubmiSliion in responoo 10 Agoncy lollordalod D "Me Too· Application 

o NotifiC3tlon· Explain below. D Otlw· Explain below. 

Explanation: Use oddiliOflill page(s) If necoIRl3/y. (For oocIion I and MClion n.) 

Section - III 

1. Material This Product Will be PacXaged In: 

Child·Rooislanl Packaging Unit Packaging Water Soluble Packagin 2. Type of Container 

B: ~YOO ~YOO X No ~~" X Plastic 

X No Glass 

"'00 Unit No. per '",00 Unil No."" X Papcr 

• Cflrlification must be Packaging wgl. cootainw- Packaging wgt . cootainer Other (Specify) 

submlUod , 3.localion of Net Conlen!; Information 4. Size(s) Retail Conlairmr 1-'1S/PAcK: 5. Location of Label Directions 

0 ... "", o Conlainor 0.05 _ 0.30 n OZ (1.5 - 9 ee) tubes, ~OnLabel On Label Accompanying Product 

6. Manner in Which label is Affl)((tlj to Product § I./fuoomph ~ othor printed on cardboard .... Paper gll.lOd 

StencikKI . Section -IV 

1. contact Palm (Complete ftotM dfrecUy below for fdontiflcation of fndfvfduaf to be contDckld, ff necausry, 10 proc(J$$ thfs C.;)pff'~'ti"n.) 

... ~ T., T~k:p.lI?np No. (Inr-lupeAnm Code) 

Nancy Huebt Senior Registration Specialist 847 -33il-5376 

Certification 6. Dale Applicalion 

I certify lhallhe stDlemonts: I have made on this form and all atlachmonts tharetp are 1rue, accurate and complele. I 

. Received 

acknowledge Ihal any knowingtv false or mililoading slillements my be punishable by fine or imprisonment or both • (;;t'\amped) undorapplicable law. 

'SYL~c;t!~ 3.TrlIe 

Senior Registration Specialist 

4. Typed Name 5. Dale 

Nancy Huebt l1-Apr-11 

EPA Form 8570-1 (Rev. 3-84) PreVIOUS ethtlOIl$ are obsolete. While _ EPA File Copy (ortglnal) Yellow- Applicant copy 

119
REGULATORY LABEL DATA SHEET 

File Name: 

Product: 

Approved: 

OVERVIEW: 

Page # 

1-2 

3 

4-8 

9-10 

RF2164 AIT COMBO 

RF2164 AIT COMBO 

Data Sheet Date: 

EPA Reg #: 

Supercedes: 

FPL per comments in EPA 3/9/11 approval letter 

Description of Major Changes 

March 2011 

2724-811 

3/9/11 

Marketing claims: General: Per 3/9/11 EPA le1ter, 4.a. - revise claim to delete 

''tighter'' and "and to help reduce the risk of adverse reactions" 

Efficacy claims: per 3/9/11 EPA Letter, 4.b. - Delete "Starts working in 15 mintutes 

[lasts up to 30 days] 

Per 3/9/11 EPA letter, 4.8. - deleted "disease" from mosquito claim 

Applicator claims: per 3/9/11 EPA letter, 4.c. - deleted "creates a barrier to" 

Per 3/9/11 EPA letter, 4.d. - deleted "Innovative flea and tick .. ," 

Net Contents: Per 3/9/11 EPA letter, 4.L - Added US measures 

EPA Reg No. - per 3/9/1 t EPA letter, 4.g - Revised to 2724-811 

Directions for Use: Per 3/9/11 EPA letter, 4.h.L - revised Use Restrictions per letter 

text 

Per 3/9/11 EPA letter, 4.h.ii - changed headings from "Retreat if 

Necessary" to "Use Restrictions" 

Per 3/9/11 EPA letter, 4.h.iii - changed from "Retreat if Necessary" to "Use 

Restrictions" (pg 5) 

EPA Reg No. - per 3/9/t 1 EPA letter, 4.g - Revised to 2724-811 

" _.- . •• -- --

1 

120
RF2164 AIT COMBO 

[Text for "Dog" must be same size as Brand Name) 

Front Panel- For Use Only on Toy (6-12 Ibs.), Small (13-31 Ibs.), Medium (32-55Ibs.), Large (56 -80 

!bs.), and Extra Large (81 Ibs. and over) Dogs 

Front Panel- For Use Only on Dogs 6 months of age or older 

[Flea & Tick [& Mosquito][TreatmentJ [and) Control] 

Spot-On Flea & Tick Control for Dogs 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide ti§Rtef [smaller] weight ranges to improve [maintain][deliverj efficacy 

]performance][flea and tick][control][protoction) and to help roduco the risk of adverse reactions on [for[ 

your dog 

Effective on indoor and outdoor dogs 

([1][3][4[[6] monthly t,ea1menlS) (1][3][4][6] Months Supply [24][4S[ doses 

Spreads naturally with dog's movement (skin and hair oi!s) 

[FormulaJ[Contains lanolin for coat conditioning] 

[Water Resistant] [to keep killing fleas and ticks in humid and wet conditions) 

[Fast Acting][Long Lasting[Kilis Fleas and Ticks by Contact] 

[Fresh][Clean[[Scent][Smell] 

[Reapply monthly] [Suitable for year-round use][Month) sticker for home calendar 

[Satisfaction guaranteed or your money back) 

[Patent Pending] 

Efficacy Claims: 

Each tube [cartridge][vial] [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

] Protects for up to (Four/4) Weeks)[One monthj[Four/4 Week [Flea][Tick[Mosquito[ Treatment] 

[Aids in Control of Ticks for up to 30 days) 

[Starts Killing Reas and Ticks within 15 minutes] 

[Starts worl,ing in 15 minutes [lasts up to ao days] 

[Kills 85% of ticks within 48 hours][Kills more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development) 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae[ [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm disease) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to [75 days)[2.5 months]] 

[Breaks Flea Life Cycle for [more than 10 weeks] up to [75 days][2.5 months] 

[Controls flea reinfestation for (more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle[ 

1 

121
Applicator Claims 

[New] [applicatorJ 

[NewJ contemporary design 

[brand name] [ApplicatorJ creates a barrier to [helps toj- prevent getting liquid on [yourJ hands 

[brand name] [ApplicatorJ tip parts hair to help [liquid][applicationJ get down to [the][your][dog's] skin 

Ergonomically contoured [ergonomic][shape][design[ for easy handling [ease of use] [easy useJ 

For use with [only][brand nameJ[disposable][liquid dispensingJ tubes [vialsJ [cartridgesJ 

[brand nameJ [applicator][hasJ[provides][aliows for][deliversJ better grip 

[brand nameJ[provides] re-closable [re-sealableJ packaging for [easyJ storage 

Closing [the][brand name][applicator] door automatically opens the [dlsposable][liquid dispensingJ tube 

[vial][cartridge] 

Innovative flea and ticl( application system [applicator] 

[brand nameJ [Applicator] [will not drip after openingJ 

[brand nameJ [Applicator] Won't drip when set down as you go fetch the [your] dog 

Includes unique [brandJ applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot-on [doseJ [product] on [toJ the wrong pet 

Convenient, easy to use ACCU-TIP [ApplicatorJ [DISPENSER[ 

[Easy to useJ Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New [disposable][liquid dispensing] tube [cartridgeJ[vialJ 

[NewJ [brand name][disposable][liquid dispensing] [tubeJ[vialJ tip [helps][to] spread out liquid [on your][dog] 

Unique [cartridge] [tube][vialJ with flow control 

[no drip][no mess][application][tube][cartridgeJ[viaIJ 

Promotional Package Copy 

One month [dose] free 

One free month supply [doseJ included 

Bonus pack 

Free [applicator][tubeJ[vial[cartridge]][insideJ 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [deviceJ not included 

[brandJ Refill Pack [brand][applicator [device] not included] 

Refill Claims 

For use [only] with [brand name][Applicator] 

([1][3][4[[6J monthly treatments) [1][3J[4][6J Months Supply [24][48J doses 

Easy to use [convenientJ refills 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

122
Thermoform name options <tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Elofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Melhoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Buloxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

'(bulyl earbilyl) (6-propylpiperonyl elher) and relaled compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients andJ Additional Precautionary Statements 

NET CONTENTS: One: 0.05 II oz (1.5 ce) [vialj[lubej[eartridgej (Toy Dogs)1 

0.10 fl OZ (3.0 ee) (vial) (Iubej(eartridge) (Small Dogs)/ 

0.15 II oz (4.5 ee) [vialj[lubej(eartridgej (Medium Dogs)1 

0.20 fl oz (6.0 ee) Iviallllubej(eartridgej (Large Dogs) 

0.30 fl oz (9.0 ee) [vialj(lubej[eartridgej (EXIra Large Dogs) 

EPA Reg. No. 2724~81 txxx 

EPA Est. No. 

[ICON - DO NOT USE ON CATS] 

3 

123
RF2164 AIT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 NT COMBO] prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for up to 30w days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier, more 

precise ww and neater - than ever before. You simply insert the appropriate [brand] tube 

[vial][cartridge[ for your dog into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design[ makes it easy to grip and a builtwin fin [tip[ [comb [ helps to 

spread [part] the [your] dog's hair to allow the liquid to more readily [better] reach [apply] the [to] [your 

dog's] skin. The tube [vial][cartridge[ is sealed inside, so you can be confident that the liquid goes 

onto your dog - and not your hand. Plus, if the applicator is laid down on a table, counter or other flat 

surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

The maximum application rate for this product is twice per month, and the second application 

must be made more than g days after the initial application. 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more 1han once p~~ , 

month. 

RF2164 NT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct appl,;c&t;oll to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube[via~[cartridge] per dog per applicatlC>tl)] 

The RF2164 NT COMBO provides a unique applicator device that allows dog: o\Jhers to treat 

their dogs more securely, and dispose of liquid cartridges [tubes][vials]with less mess. 

4 

124
[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Retreat If NecessaryUse Restrictions, so 

the minor differences relate to device features. Potential icon designs are on the last 

pages of this document. Text appearing on icon pages is for illustrative purposes only 

and does not represent full text as indicated in DFU which will appear on labeL] 

[DFU Set No.1] 

FOR [TOYJ[SMALLJ[MEDIUM] SIZE DOGS 

To apply the [RF2164 AIT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicator device, ensuring that the 

cartridge [vial]]tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [Nquid] cartridge 

[vial][tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 Aff COMBO evenly to [two 

spots](toy dogs)[three spots]{small dogs){medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][button]]thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 Aff COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side ]buttons together] to open 

applicator device door and discard empty cartridge ]tube][vial] into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in original package.]. 

6. RETREAT IF ~IECESSAR¥USE RESTRICTIONS: Do not reapply product for 30 days 

unless re-treatment is required, but not sooner than 8 days after the initial treatment. Qo,' 

not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubeslvials for]X] applicafronsl' 

FOR [LARGEJ[EXTRA LARGE] DOGS 

1 

2 

3 

4 The dog should be standing for easy application. Apply RF2164 AIT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

5 

125
5 

6 

down on the round [circle][button[[thumb pad] to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. Do not spread RF2164 AJT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

tOFU Set No.2] 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AJT COMBO] treatment, use one disposable liquid cartridge [tube[[vial] 

[for each application] with the applicator device. 

t. OPEN [icon] 

With green door facing downward, push side [buttons] to open applicator. 

2. LOAD [icon[ (3 alternate statements) 

-[To Load, insert tube [cartridge][vial] [color side down][white side up]. Press down on tube 

[cartridge][vial][ until [two green] tabs click in place]. 

-[To Load, place tube[cartridge][vial]under the [color, e.g. green] tabs] [in the applicator] 

-[To Load, place tube[cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [ioon] 

Point tip up and close the [color, e.g. green] door. The tube [cartridge][vlal] will snap open and is now 

ready to apply. 

4. APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green door] [Press round thumb pad] once at each of [two[ (Toy dogs) [three] 

(Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 AJT COMBO by hand over the dog. 

Although the dog's skin and hair oils will naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. RETREAT IF NEGESSAR¥USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not soonf!r than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains suffident cartridges/tubes/vials for [X] applications), 

6 

126
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 ... 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green door][Press round thumb pad] once at each of four or five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 AIT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 

6 ... 

[DFU Set No.3] 

FOR [TOY][SMALL][MEDIUM]DOGS 

To apply the [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

[for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]under the [color, e.g. green] tabs ][in the applicator] 

-[To Load, place tube [cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green door once at each of [two] (Toy dogs) [three[ (Small 

Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that could cause some of the solution to run off 

the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

To dispose of empty tube, open [color, e.g. green] door and drop empty tube !Ilto,tr?sh or off!3r for 

recycling if available. [Close applicator device door and store in original packe:..ge:] 

6. RETREAT I>' NECESSlIRYUSE RESTRICTIONS . 

Do not reapply product for 30 days unless re-treatment is required, but not SOUIlp.'f'(han 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications] 

7 

127
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 .. . 

3 .. . 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green door once at each of four or five evenly placed spots 

between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any 

one spot that could cause some of the solution to run off the side of the dog. Do not spread RF2164 

AfT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to distribute the 

material over the skin. 

S 

6 ... 

RF2164 AfT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AfT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AfT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosane: 1 rcartridael rtubelfvia! everv 30 days er doa 

Pet's Name First Treatment Date se~ond Treatment Date T~ird Treatment D~~e 30 Davs From 1 st) 30 Davs From 2 

Reminder: ! purchased RF2164 Aff COMBO from: 

NOTES:_~_~ __ _ 

Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse cartridge [vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For external use on':y. C&uses'mop,orate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap Cl.!IU water after 

handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Re:?'ea!eii 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before 'U3lrlg this p'n:,duct on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may o'ccur after u~ing 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet with mild soap al1iJ rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the application site. If sidns persist 

or become more severe, contact veterinarian immediately and report incident to company at 

1 -800-XXX-XXXX. 

8 

128
FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15~20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1 ~800·xxx~xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBEICARTRIDGEiVlAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811)()()( 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12 Ibs.), Small (13--31 Ibs.), Medium (32~55Ibs.), Large (56 ~80 Ibs.), aCld ' 

Extra large (81 Ibs. and over) Dogs 6 months of age or older 

9 

129
[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot~On Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

PiperonylButoxide (CAS # 51~03~6)* ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

'(butyl carbityl) (6-propylpiperonyl elher) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

EPA Reg. No. 2724-JGG(S11 

EPA Est No. 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AIT COMBO treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube [cartridge][vial] from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device. If you need directions for application, please can1~800~XXX~XXXX. 

(Precautionary and Storage/Disposal) text included) 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

10 

130
Alternate Sets of ICONS for the RF2164 AfT COMBO 

[ICON SET 1] 

[OPEN] 

[LOAD] 

[CLOSE] 

[APPLy] 

[DISPOSE] 

11 

131
[ICON SET 2] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

two side 

UP 

Close 1f1e green door and 

the tube will snap open. 

To APPLY Use Tip to parttur 

and get nextto dOg'sskfn. 

Press circle on green door 

once at each of # s!X)ts 

between shoUlders 

and tail 

DISPOSE of ""l'iy tube 

PUGh tvvo side buttons to 

open green door and 

drop 

("#Spots" is a variable dependent on size) 

Alternate LOAD icon 

To LOAD place tube WHITE Side UP 

~ooerthe 

CLOSE the green door 

and !he tube will snap opert 

1:1-

132
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific 10 dog's size) 

Use finger sooop to lit! OPEN door 

To LOAD place tube WHITE side UP 

~rthegreentabs 

To APPLY Use Tip to part fur , next to dog's skin. 

on green door 

once al each 01 # spots 

between shoulders 

and tail 

("#Spots" is a variable dependent on size) 

12 /3 

133
NOT REVIEWED 

In Ac( lance with PR Notice 82.2 

Based vd Draft LabeliM Dated 

RF2164 AIT COMBO-__ ~-",,=-'l.L--,!~~II~ __ 

[Text for "Dog" must be same size as Brand Name] 

Front Panel ~ For Use Only on Toy (6 R 12Ibs.), Small (13 R 31 Ibs.), Medium (32-55 Ibs.), Large (56 -80 

Ibs.), and Extra Large (81Ibs. and over) Dogs 

Front Panel - For Use Only on Dogs 6 months of age or older 

[Flea & TIck [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs 

Genera! Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide ]smaller] weight ranges to improve [maintain]deliver] efficacy 

]performance]f1ea and tick]]controJ]protection] on ]for] your dog 

Effective on indoor and outdoor dogs 

([1][3]4]6] monthly treatments) [1]3]4]6] Months Supply [24]48] doses 

Spreads naturally with dog's movement (skin and hair oils) 

]FormuJaDContains lanolin for coat conditioning] 

]Water Resistant] ]to keep killing fleas and ticks in humid and wet conditions] 

]Fast Acting] Long Lasting]KiIIs Fleas and Ticks by Contact] 

] Fresh][CleanlOScent]Smell] 

]Reapply monthly] [Suitable for year-round use [Month] sticker for home calendar 

]Satisfaction guaranteed or your money back] 

] Patent Pending] 

Efficacy Claims: 

Each tube [cartridge][vial] ]application] ]kills fleas & ticks for 3 weeks] and ] kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to ] Four/4] Weeks][One month][Four/4 Week ]Flea][fick]Mosquito] Treatment] 

]Aids in Control of Ticks for up to 30 days] 

]Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hoursllKilis more than 50% of fleas in 2 hours] 

]Dual Action kills adult fleas and prevents flea development] 

]Kills fleas, ticks, mosquitoes, flea eggs and flea larvae) [Dual protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm-) 

Monthly application for most effective protection 

IGRClaims: 

[Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to]75 days][2.5 months)] 

]Breaks Flea Life Cycle for]more than 10 weeks] up to]75 days[2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months) 

[With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

1 

134
Applicator Claims 

[New[ [applicator] 

[New] contemporary design 

[brand name] [Applicator] helps to prevent getting liquid on [your] hands 

[brand name] [Applicator] tip parts hair to help [liquid][application] get down to [the][your][dog's] skin 

Ergonomically contoured [ergonomic][shapeITdesign] for easy handling [ease of use] [easy user 

For use with [only[brand name][disposable[liquid dispensing] tubes [vials] [cartridges] 

[brand name] [applicator][has][provides][allows for][delivers] better grip 

[brand name[provides] re-closable [re-sealable] packaging for [easy] storage 

Closing [the][brand name][applicator] door automatically opens the [disposable[liquid dispensing] tube 

[viaIJlcartridge] 

[brand name[ [Applicator] [will not drip after opening] 

[brand name] [Applicator] Won't drip when set down as you go fetch the [your] dog 

Includes unique [brand] applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot-on [dose] [product] on [tor the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER[ 

[Easy to use] Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New [disposable][liquid dispensing[ tube [cartridge][vial] 

[New] [brand name][disposable][liquid dispensing] [tube][vial] tip [helps[to] spread out liquid [on your][dog] 

Unique [cartridge[ [tube][vial] with flow control 

[no drip][no mess][applicationJ[tube[cartridgeJ[vial] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator][tube][vial[cartridge]][inside] 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand[ applicator 

Applicator [device] not included 

[brand] Refill Pack [brand[applicator [device] not included] 

Refill Claims 

For use [only] with [brand name][Applicator] 

([1J13J14[[6[ monthly trearnents) [1][3][4J16] Months Supply [24J148] doses 

Easy to use [convenient[ refills 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

135
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*(butyJ carbityJ) (6-propyJpiperonyJ ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: 

EPA Reg. No. 2724-811 

EPA Est. No. 

One: 0.05 fI oz (1.5 cc) [vial[fJube[fcartridge] (Toy oogs)/ 

0.10 fl oz (3.0 cc) [viaJlltubellcartridge] (SmaH oogs)/ 

0.15 fI oz (4.5 cc) [viall[tubel[cartridge] (Medium oogs)/ 

0.20 fI oz (6.0 cc) IviaJ[ftube[fcartridge[ (Large Dogs) 

0.30 fI oz (9.0 cc) [vial][tube][cartridgel (Extra Large Dogs) 

[ICON - DO NOT USE ON CATS] 

3 

136
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[RF2164 AlTCOMBO[ prevents flea eggs from developing into adult fleas [more than 10 

weeks] for up to [75 days][2.5 months]. RF2164 AIT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier, more 

precise -- and neater - than ever before. You simply insert the appropriate [brand[ tube 

[vial][cartridge] for your dog into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [design] makes it easy to grip and a built-in fin [tip[ [comb] helps to 

spread [part[ the [your] dog's hair to allow the liquid to more readily [better] reach [apply] the [tor [your 

dog's] skin. The tube [vial][cartridge] is sealed inside, so you can be confident that the liquid goes 

onto your dog - and not your hand. Plus, if the applicator is laid down on a table, counter or other flat 

surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 AfT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube[vial][cartridge] per dog per application)] 

The RF2164 AfT COMBO provides a unique applicator device that allows dog owners to treat 

their dogs more securely, and dispose of liquid cartridges [tubes][vials]with less mess. 

4 

137
[Note: Each package contains sufficient cartridges/tubes/vials lor [X] applications] 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minor differences 

relate to device features. Potential icon designs are on the last pages of this document. 

Text appearing on icon pages is for illustrative purposes only and does not represent 

lull text as indicaled in DFU which will appear on label.] 

[DFU Set No.1] 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][lor each application] with the applicator device. 

1. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicator device, ensuring that the 

cartridge [vial][tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid] cartridge 

[vial][tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 AfT COMBO evenly to [two 

spots](toy dogs)[three spots](small dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][button][thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 AfT COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side [buttons together] to open 

applicator device door and discard empty cartridge [tube][vial[ into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in original package.] 

6. USE RESTRICTIONS: Do not reapply product for 30 days unless re-treatment is required, 

but not sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

[Note: Each package contains sufficient cartridgesltubes/vials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 The dog should be standing for easy application. Apply RF2164 AfT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

5 

138
5 

6 

down on the round [circie][button][thumb pad] to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run all the side of the dog. Do not spread RF2164 AIT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

[DFU Set No.2) 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AIT COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

[for each application] with the applicator device. 

1. OPEN [icon] 

With green door facing downward, push side [buttons] to open applicator. 

2. LOAD [icon] (3 alternate statements) 

-[To Load, insert tube [cartridge][vial] [color side down][white side up]. Press down on tube 

[cartridge][vial][ until [two green] tabs click in place]. 

-[To Load, place tube[cartridge][vial]underthe [color, e.g. green] tabs] [in the applicator] 

-[To Load, place tube[cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE ]icon] 

Point tip up and close the leolor, e.g. green] door. The tube [cartridge][vialj will snap open and is now 

ready to apply. 

4. APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green door] [Press round thumb pad] once at each of [two] (Toy dogs) [three] 

(Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 AfT COMBO by hand over the dog. 

Although the dog's skin and hair oils will naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

6 

139
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green door]IPress round thumb pad] once at each of four or five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 NT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 

6 ... 

[DFU Set No.3] 

FOR [TOy][SMALL][MEDIUM]DOGS 

To apply the [RF2164 NT COMBO] treatment, use one disposable liquid cartridge [tube][via~ 

[for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]under the [color, e.g. green] tabs ]]in the applicator] 

-[To Load, place tube [cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge][vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green door once at each of [two] (Toy dogs) [three] (Small 

Dogs) (Medium dogs) evenly placed spots between the shOUlder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that could cause some of the solution to run off 

the side of the dog. Do not spread RF2164 NT COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12~24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

To dispose of empty tube, open [color, e.g. green[ door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

] Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

7 

140
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 .. . 

3 .. . 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green door once at each of four or five evenly placed spots 

between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any 

one spot that could cause some of the solution to run off the side of the dog. Do not spread RF2164 

AJr COMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to distribute the 

material over the skin. 

S 

6 ... 

RF2 t64 AfT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AJr COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AfT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosaoe: 1 Icartridoelltub~ilvi;li everv 30 davs erdoa 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Dl~~e 

(30 Davs From 1st) (30 Davs From 2nd 

Remmder. t purchased RF2164 AfT COMBO from. ______ _ 

NOTES: 

Treatme'cn'Ct t"a"b"le-'cC:a"n-cb-::e-=e'Cx"-pa:::n:-:ded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial[[tube] Disposal: If empty: Do not reuse cartridge [vial[ 

[tube]. Place in trash or offer for recycling if available. If partIally filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For external use only. Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the application site. If signs persist 

or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

8 

141
FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15~20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calHng a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Selier makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with appticable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1 ~800~xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBE/CARTRIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS) 

For Use Only on Toy (6~12Ibs.), Small (13-31 Ibs.), Medium (32~55 Ibs.), Large (56 ~80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

9 

142
[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

SpotROn Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 5 t-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*{bUlyl carbityl} (6-propylpiperonyl ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AlT COMBO treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube ]cartridge][vial] from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device. If you need directions for application, please call1-800-XXX-XXXX. 

(Precautionary and StoragelDisposal) text included) 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

10 

143
Alternate Sets of ICONS for the RF2164 AIT COMBO 

[ICON SET 1) 

[OPEN) 

[LOAD) 

[CLOSE) 

[APPLy] 

[DISPOSE) 

11 

144
[ICON SET 2] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

green door facing down 

Push two side bullooS 

To LOAD Place tube with 

Close the green doer and 

the tube will snap open 

To APPLY Use l1pto parttur 

and get next to dog's skill 

Press circle on green door 

once at each of # spots 

between shoulders 

and tall 

DISPOSE of empty tube 

\:INO side buttons to 

and 

("#Spots" is a variable dependent on size) 

Alternate LOAD icon} 

To LOAD place tube WHITE skie UP 

~ 

CLOSE the green door 

and the tube will snap open. 

12-

145
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

sooop 10 \ill OPEN door 

To LOAD place tube WHITE_ UP 

~r1hegreentabs 

CLOSE Hle green door 

and the tube will 

To APPLY Use Tip to partfur 

and get next to dog's skin. 

~ ro~ cirde on greendoor 

once at each of # spots 

between shoulders 

andlall 

C'#Spots" is a variable dependent on size) 

213 

146
RF2164 AlT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Panel M For Use Only on Toy (6-12Ibs.), Small (13-.31 Jbs.), Medium (32-55 Jbs.), Large (56 -80 

Jbs.), and Extra large (81 !bs. and over) Dogs 

Front Panel - For Use Only on Dogs 6 months of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs 

Genera! Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide IsmaUer[ weight ranges to improve [maintainITdeJiverI efficacy 

IperformanceITfJea and tickf[controJITprotection[ on [for] your dog 

Effective on indoor and outdoor dogs 

([1J[3ll4J[6[ monthly treatments) [1 [3[4[6[ Months Supply [24[48[ doses 

Spreads naturally with dog's movement (skin and hair oils) 

IFormulaITContains lanolin for coat conditioning [ 

[Water Resistant{ {to keep killing fleas and ticks in humid and wet conditions{ 

[Fast Acting[Long LastingITKills Fleas and Ticks by Contact{ 

[Fresh [Clean [[ScentllSmell [ 

[Reapply monthly[ {Suitable for year-round use][Month{ sticker for home calendar 

{Satisfaction guaranteed or your money back{ 

{Patent Pending[ 

Efficacy Claims: 

Each tube [cartridge][vial{ [appJication[ {kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks{ 

{Protects for up to {Four/4{ Weeks[One month [Four/4 Week [Flea[fTick][Mosquito] Treatment] 

{Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

[Kills 85% of ticks within 48 hoursf[Kills more than 50% of fleas in 2 hours{ 

{Dual Action kills adult fleas and prevents flea development[ 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae]]Dual protection (against fleas and ticks){ 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repels mosquitoes (the major carrier of canine heartworm-) 

Monthly application for most effective protection 

IGRClaims: 

]Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks{ up to ]75 days[2.5 months[[ 

[Breaks Flea Life Cycle for {more than 10 weeks] up to [75 days[2.5 months[ 

[Controls flea reinfestation for [more than 10 weeks] up to [75 daysf[2.5 months[ 

[With {S-Methoprene{ Insect Growth Regulator [IGR[ to Break Flea Life Cycle[ 

1 

147
Appncator Claims 

[New] [applicator] 

[New] contemporary design 

]brand name] ]Applicator] helps to prevent getting liquid on ]your] hands 

]brand name] ]AppJicator] tip parts hair to help ]JiquidllappJication] get down to [thellyour]]dog's] skin 

Ergonomically contoured [ergonomicIIshapeIIdesign] for easy handling lease of use] [easy use] 

For use with [onlyllbrand namelldisposableIIliquid dispensing] tubes ]vials] [cartridges[ 

]brand name] [appJicator1[hasIIprovidesIIaJlows forlldelivers] better grip 

]brand name[provides] re-closable [re-sealable] packaging for ]easy] storage 

Closing ]the[brand namellapplicator] door automaticaJly opens the ]disposableIIliquid dispensing] tube 

]viaillcartridge] 

]brand name] ]Applicator] ]will not drip after opening] 

]brand name] ]Applicator] Won't drip when set down as you go fetch the [your] dog 

Includes unique ]brand] applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot-on Idose] ] product] on Ito] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER] 

]Easy to use] Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New ]disposableJ[Jiquid dispensing] tube [cartridge][vial] 

]New] ]brand nameIIdisposable[liquid dispensing] [tubellvial] tip [helps[to] spread out liquid [on your][dog] 

Unique ]cartridge] ]tubeJ[vial] with flow control 

]no dripllno mess][applicationIItubeJ[cartridge][vial] 

Promotional Package Copy 

One month Idose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator][tubeJ[vial[cartridge]][inside] 

Des'lgned not to drip when set on top of the counter, or table, or other flat surface, 

For use with [brand] applicator 

Applicator ]device] not included 

]brand] RefiJl Pack [brandJ[applicator [device] not included] 

Refill Claims 

For use ]only] with [brand name][AppJicator] 

([1]J3TI4]]6] monthly treatments)]1 [3]]4]]6] Months Supply ]24]]48] doses 

Easy to use [convenient] refills 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

148
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

*(butyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: One: 0.05 fI 02 (1.5 ee) [vialJ[tube]feartridge] (roy Dogs)1 

0.10 fl OZ (3.0 ee) [vial] [tubeJ[cartridge] (Small Oogs)1 

0.15 fI 02 (4.5 ee) fvialJftubeJfcartridge] (Medium Dogs)1 

0.20 fI oz (6.0 ee) [viaIUtube][cartridgej (large Dogs) 

EPA Reg. No. 2724~811 

EPA Est. No. 

0.30 fI oz (9.0 ee) fvialJ[tubeJfeartridge[ (Extra large Dogs) 

[ICON - DO NOT USE ON CATS] 

3 

149
RF2164 AIT COMBO 

IMPORTANTI DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS I 

[RF2164 NT COMBO) prevents flea eggs from developing into adult fteas [more than 10 

weeks) for upto [75 days)[2.5 months). RF2164 NT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.J 

Effective flea & tick control for your dog. 

[brandJ provides flea and tick protection fOf dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kW adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brandJ Applicator is specially designed to make applying flea and tick control eaSIer, more 

precise -- and neater - than ever before. You simply insert the appropriate [brandJ tube 

[vialJ[cartridgeJ for your dog into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [designJ makes it easy to grip and a built-in fin [tipJ [combJ helps to 

spread [part) the [your) dog's hair to allow the liquid to more readily [better) reach [apply) the [to) [your 

dog'sJ skin, The tube [vialJ[cartridgeJ is sealed inside, so you can be confident that the liquid goes 

onto your dog - and not your hand. Plus, if the applicator is laid down on a table, counter or other flat 

surface, it won't run out or drip, 

DIRECTIONS FOR USE: It is a violation of Federal Law to use th'ls product in a manner 

inconsistent with its labeling, Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

Apply this product once every 30 days unless a retreatment is necessary. Do not make the 

retreatment sooner than 8 days after the initial treatment. Do not retreat more than once per 

month. 

RF2164 AfT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube[vialJ[cartridgeJ per dog per application)J 

The RF2164 AfT COMBO provides a unique applicator device that allows dog owners to treat 

their dogs more securely, and dispose of liquid cartridges [tubesJ[vialsJwith less mess. 

4 

150
[Note: Each package contains sufficient cartridgesltubes/vJals for [X] applicationsJ 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minor differences 

relate to device features. Potential icon designs are on the last pages of this document. 

Text appearing on icon pages is for illustrative purposes only and does not represent 

full text as indicated in DFU which will appear on labeL] 

[DFU Set No.1] 

FOR [TOy][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

1. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vial][tube] in the applicator device, ensuring that the 

cartridge [vial][tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid] cartridge 

[vial][tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 AfT COMBO evenly to [two 

spots](toy dogs)[three spots](small dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][button][thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 AlT COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push s·rde [buttons together] to open 

applicator device door and discard empty cartridge [tube][vial] into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in Original package.] 

5. USE RESTRICTIONS: Do not reapply product for 30 days unless re-treatment is required, 

but not sooner than 8 days after the init"ral treatment. Do not retreat more than once per 

month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 The dog should be standing for easy application. Apply RF2154 AfT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

5 

151
5 

6 

down on the round [circleJ[buttonJ[thumb padJ to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spat that could cause 

some of the solution to run off the side of the dog. Do not spread RF2164 AfT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

[DFU Set No. 2J 

FOR [TOYJ[SMALLJ[MEDIUMJ SIZE DOGS 

To apply the [RF2164 AfT COMBOJ treatment, use one disposable liquid cartridge [tubeJ[vialj 

[for each application] with the applicator device. 

1. OPEN [iconJ 

With green door facing downward, push side [buttons] to open applicator. 

2. LOAD [iconJ (3 alternate statements) 

-[To Load, insert tube [cartridge][vial] [color side down][white side up]. Press down on tube 

[cartridgeJ[viaIJ[ until [two greenJ tabs click in placeJ. 

-[To Load, place tube[cartridgeJ[viaIJunderthe [color, e.g. greenJ tabsJ [in the applicatorJ 

-[To Load, place tube[cartridgeJ[viaIJ white side up into the applicatorJ 

[Ensure that tube [cartridgeJ[vialj fits securely in the applicator.J 

3. CLOSE [iconJ 

Point tip up and close the [color, e.g. green] door. The tube [cartridge}[viaG wiJ/ snap open and is now 

ready to apply. 

4. APPLY pconJ 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green door] [Press round thumb pad] once at each of [two] (Toy dogs) [three] 

(Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 AJT COMBO by hand over the dog. 

Although the dog's skin and hair oils wiJ/ naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [iconJ 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

6 

152
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green door}[Press round thumb pad] once at each of four Of five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that CQuid cause some of the so/utlon to run 

off the side of the dog. Do not spread RF2164 AIr COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 

6 ... 

[DFU Set No.3] 

FOR [TOy][SMALL][MEDIUM)DOGS 

To apply the [RF2164 AIr COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

[for each application] with the applicator device. 

1. OPEN [icon] 

Use finger scoop to lift open door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]under the [color, e.g. green] tabs ][in the applicator] 

-[To Load, place tube [cartridge][viaJ] white side up into the applicator] 

[Ensure that tube [cartridgeJ[vial] fits securely in the applicator.] 

3. CLOSE [icon] 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb pad] on green door once at each of [two] (Toy dogs) [three] (Small 

Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that could cause some of the solution to run off 

the side of the dog. Do not spread RF2164 AIr COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

To dispose of empty tube, open [color, e.g. green] door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. USE RESTRICTIONS 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

7 

153
FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 .. . 

3 .. . 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[roundJ thumb pad] on green door once at each of four or five evenly placed spots 

between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any 

one spot that CQuid cause some of the solution to run off the side of the dog. Do not spread RF2164 

NT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to distribute the 

material over the skin. 

S 

6 ... 

RF2164 AfT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name J products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 NT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 Aff COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.J 

TREATMENT SCHEDULE 

Dosage: 1 Icartridge] [tubel[vial] every 30 days erdo!=) 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 1") (30 Days From 2"') 

Reminder: I purchased RF2164 AIT COMBO from: 

NOTES:.~--,-,_-c_-c_. 

Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [viaIJ[tubeJ Disposal: If empty: Do not reuse cartridge [vialJ 

[tubeJ. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For external use only. Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handnng and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the application site, If signs persist 

or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

8 

154
FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label With you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-800-xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

WeI/mark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URLj 

Made in USA 

TEXT FOR LIQUID TUBEICARTRIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-811 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12Ibs.), Small (13-31 Ibs.), Medium (32-55Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

9 

155
[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

Spot-On Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS; 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS; ................................................................................ 61.4% 

TOTAL 100.0% 

~(butyt carbityt) (6-propylpiperonyt ether) and related compounds 

EPA Reg. No. 2724-811 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used if space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AfT COMBO treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device. 

Remove one refill tube [cartridgeHvialj from the package and insert into opened [brand name] 

applicator device. Make application according to label directions supplied with the [brand 

name} applicator device. If you need directions for application, please call1-800-XXX-XXXX. 

(Precautionary and Storage/Disposal) text included) 

Wellmark Intemational 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

10 

156
Alternate Sets of ICONS for the RF2164 AfT COMBO 

[ICON SET 1] 

[OPEN] 

[LOAD] 

[CLOSE] 

[APPL YJ 

[DISPOSE] 

11 

157
VCON SET 2) ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

green door facing 

Push two side 1lu11oos 

To LOAD Place tube with 

Close the green door and 

the tube wm snap open. 

To APPLY Use l1pto partfur 

and get next to dog's skin_ 

Press cirde on green:door 

once at each of it spots 

bet\¥een shoulders 

and tal 

DISPOSE of empty tube 

1vIo skJe buttons to 

green door and 

drop 

(U#Spots" is a variable dependent on size) 

(Alternate LOAD icon 

- UP 

CLOSE1he green door 

and the lube will snap open. 

1"-

158
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

Use linger sooop 10 ill OPEN door 

To LOAD place tube WHITE side UP 

~ 

CLOSE the green door 

and the tube will snap open 

To APPLY Use Trp10 parttur 

and gel next 10 dog's skin. ,~r , __ circle 00 green door 

once at each of # spots 

between shoulders 

and tail 

("#Spots" is a variable dependent on size) 

159
Material to be added to an e-Jacket/Jacket 

Reg. No. 2724-811 

Description: New Registration 

1. Placement within the e-Jacket/jacket: 

X Default: (chronological, top = newest) 

o File Location: (PDF page number, i.e., "before page 

45") 

2. X Send to Data Extraction contractors this material: 

X Newly stamped accepted label 

o Notification 

X NewCSF 

X Other: Correspondence 

3. Attach this coversheet to the top of the material or jacket. It 

must be well organized and clipped together, NOT STAPLED. 

Then give the material with this coversheet to staff in the 

Information Services Center (Room S-4900). 

Reviewer's Name: Kevin Sweeney 

Phone: ~3"",O"",5"----",5-",O-",6,,,,-3 ____ D ivi s ion: --!.R..!-"D"--__ 

Date: ~3~/1~4~/~20~1~1~ __________________ __ 

Created March 14, 2011 

160
~\i\Oosr",~ U.S. ENVIRONMENTAL PROTECTION EPA RegiSlralion No. Dalc of Issuance: 

. • ft • . AGENCY ~ U Office of Pesticide Programs 2724-811 MAR -9 2011 ~S!fZ~ Registration Division (7505P) - \, ~...; 1200 Pennsylvania Ave., N.W. 

'%0)": ",<,0 Washington, D.C. 20460 "It PRO""\"~ 

Term oflssuancc: 

NOTICE OF PESTICIDE, Conditional Registration 

0" Registration Expires March 10,2013 

o Reregistration 

(under the Federal Insecticide, Fungicide, Name of Pesticide Product: 

RF2164 AIT COMBO 

and Rodenticide Act, as amended) 

Name and Address of Registrant (include ZIP Code): 

Wellmark International 

1501 E. Woodfield Road 

Suite 200W 

Schaumberg, Illinois 60173 

Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and 

accepted by the Registration Division prior to use of the label in commerce. In any correspondence on this product always refer 

to the above EPA registration number. 

On the basis of infonnation furnished by the registrant, the above named pesticide is hereby registered under the 

Federal Insecticide, Fungicide and Rodenticide Act. 

Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In 

order to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel the 

registration of a pesticide in accordance with the Act. The acceptance of any name in connection with the 

registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive use of the 

name or to its use if it has been covered by others. 

This product is conditionally registered in accordance with FIFRA sec. 3{c)(7)(a) provided that: 

I. This registration is time-limited and expires two years from the date this product is first released 

for shipment. 

You must provide the Agency with a projected release for shipment date within 30 days of the date 

of this Notice of Registration. The Agency will calculate the expiration date based on the 

projected release for shipment date until an actual release for shipment date is provided in writing. 

2. Only one confidential statement of formula (CSF) (basic) will be filed for this product; no alternate 

formulation or minor formulation statements may be submitted or approved for this product. 

3. The basic CSF dated November 19, 2010 is acceptable and becomes the CSF of record. The 

alternate formulation CSF # I dated November 19,2010 is not acceptable. 

4. Make the following changes to the label: 

a. Change: 

"5 size categories provide tighter (smaller] weight ranges to improve [maintain][deliver] 

efficacy[p~rfonnance ][flea and tick][control][protection] and to help reduce the risk of adverse 

161
reactions on [for] your dog." to "5 size categories provide [smaller] weight ranges to improve 

[maintain][ deliver] efficacy [performance][flea and tick][control][protection] on [for] your 

dog." 

b. Remove: "Starts working in 15 minutes [lasts up to 30 days]." 

c. Change: 

"[brand name] [applicator] creates a barrier to [help] prevent getting liquid on [your] hands." 

to "[brand name] [applicator]helps to prevent getting liquid on your hands." 

d. Remove: "Innovative flea and tick application system [applicator]". 

e. Change: "Kills and repels mosquitoes (the major carner of canine heartworm disease)" to 

"Kills and repels mosquitoes (the major carrier of can me heartworm)" 

f. The claim "New [formula]" and other claims employing the word 'New' may appear on 

product produced for 6 months from the date of first distribution only. 

g. Revise the EPA Registration Number to read: "EPA Registration No. 2724-811. 

h. Based on comments made in the Companion Animal Safety Data Evaluation Report dated 

February 5, 2009: 

i. Change: 'USE RESTRICTIONS' to read: "Apply this product once every 30 days unless a retreatment is necessary. Do not make the re-treatment sooner than 8 days after the initial 

treatment. Do not retreat more than once per month." 

ii. Change the heading: 'Retreat if Necessary' to 'Use Restrictions' on all labeling. 

iii. At the bottom of page 4 change" 'Reapply if Necessary' to 'Use Restrictions' 

i. Include American units of volumetric measure on your label. This includes the volume of the 

vials, which are currently only expressed in milliliters. Add the equivalent American liquid 

measure expressed in ounces (oz.). 

5. You must submit enhanced incident reports for this product on a quarterly basis beginning April 1 , 

2011. Please flag any Confidential Business Information as such. Enhanced incident reporting 

should be submitted to the Product Manager. Quarterly sales information should be submitted to 

the Registration Division (7505P), Insecticides Branch (ATTN: Richard Gebken). 

The following is a list of information needed by EPA to better characterize these incidents: 

EPA Registration Number 

Product name (brand name) 

Lot # 

Where purchased: internet, store, veterinarian 

Active Ingredient(s) 

Weight range for product 

Date on which incident occurred. (mmJdd/yyyy) 

State in which the incident occurred. (standard 2 letter abbreviation) 

Registrant case # 

Species: dog, cat, other (specity) 

Breed: (as reported by pet owner) 

162
Age: months or years 

Sex: M, F, or neutered 

Weight: pounds 

Primary Route of Exposure: dennal, oral, other animal, inhalation, other 

Body System: neurological, dennatologicaI, GI, respiratory, ocular, other 

Major signs noted with separate column for each sign, using standard tenninology 

Time to Onset: (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) 

Any known precondition 

EPA Severity Code: death, major, moderate, minor 

Outcome: died, recovered, still treated, unknown 

6. Along with the enhanced incident reporting, you must submit an analysis of the incidents seen, to 

include the following details: 

All incidents should be reported including all minor dermal and ocular irritation reports. 

Summary table for dogs showing number of incidents of each severity code for each route 

of exposure. Each incident should only be reported once. If one incident has several 

routes of exposure, the order should be ocular> oral> dennal. In other words, an incident 

with both oral and dennal exposure would be reported as oral exposure, and an incident 

with both ocular and oral exposure would be reported as ocular exposure. 

A similar swnmary table for cats (misuse or secondary exposure) showing number of 

incidents of each severity code for each route of exposure. 

Summary table for dogs and table for cats showing number of incidents that are believed 

due to secondary exposure (e.g., multi~pet households). 

A summary table for dogs showing number of incidents for each severity code for these 

age ranges: <3 months, 3~6 months, 6~9 months, 9~ 12 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 

yr, 7 yr, 8 yr, 9 yr, 10 yr, 11 yr, 12 yr, 13 yr, 14 yr, 15 yr, > 15 yr. 

A summary table showing the number of dog incidents for each severity code for each pet 

weight range on the product label. 

A summary table for dog weight showing number of incidents for each product weight 

range. This table should show number of incidents in dogs weighing less than that product 

weight range, number of incidents in dogs in lower half of weight range, number of 

incidents in dogs in upper half of weight range, and dogs weighing more than the product 

weight range. 

Table showing number of incidents for each dog breed. 

Table showing number of incidents in dogs for each clinical sign. 

Table showing number ofincidents in dogs for each organ system. 

Report aggregate incidents, but do not combine moderate and minor incidents. 

163
7. You must submit and/or cite all data required for registration of your product under FIFRA Section 

3(c)(5) when the Agency requires all registrants of similar products to submit such data, and 

submit acceptable responses required for reregistration of your product under FIFRA section 4. 

8. The acute toxicity profile for this product is as follows: 

Route of Exposure 

Acute oral toxicity 

Acute dennal toxicity 

Acute inhalation toxicity 

Primary eye irritation 

Primary skin irritation 

Dennal sensitization 

Toxicity Category 

IV 

IV 

IV 

III 

IV 

Negative 

A stamped copy of the label is included for your file. Two copies of the finished labeling must be 

submitted prior to releasing the product for shipment. If these conditions are not complied with, the 

registration will be subject to cancellation in accordance with FIFRA sec. 6(e). Your release for shipment 

of the product constitutes acceptance ofthese conditions. 

If EPA determines that future mitigation measures are necessary for all pet spot-ons, the Agency will 

inform registrants. Ifmitigation measures are necessary, EPA may take regulatory action. If you have any 

questions concerning this registration, please contact Kevin Sweeney at (703) 305-5063. 

, / 

Sigll";ir~f APP,\\,g :da10 I Ri.a,~\:..w'~ Pnj t Manage; (10) 

Registration Division tsecticide Branch 

EPA Form 8570>6 

Date: 

MAR 9 2011 

164
RF2164 AfT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Pane! R For Use Only on Toy (6 R 12 Ibs.), Small (13 R 31 Ibs.), Medium (32R55Ibs.), Large (56 R80 

Ibs.), and Extra large (81 lbs. and over) Dogs 

Front Panel R For Use Only on Dogs 6 months of age or older 

[Flea & Tick [& Mosquito][Treatment] [and] Control] 

SpotROn Flea & Tick Control for Dogs 

Genera! Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide tighter [smaller]weight ranges to improve [maintain][deliver[ efficacy 

[performanceUfiea and tick[[controIUprotection] and to help reduce the rjsk of adverse reactions on ]for] 

your dog 

Effective on indoor and outdoor dogs 

([1 [3][4[[6J monthly treatments) [1][3J14J16J Months Supply [24[48J doses 

Spreads naturally with dog's movement (skin and hair oils) 

[Formula][Contains lanolin for coat conditioning] 

]Water Resistant] [to keep killing fleas and ticks in humid and wet conditions[ 

[Fast Acting][Long Lasting][Kilis Fleas and T'lcks by Contact] 

[Fresh [Clea n [[Scent JlSmellJ 

[Reapply monthly] [Suitable for yeaHound use [Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent Pending] 

Efficacy Claims: 

Each tube [cartridge][vial] [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeks][One month][Four/4 Week 1 Flea][Tick][Mosquito] Treatment] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within 15 minutes] 

] Starts working in 15 minutes [lasts up to 30 days] 

[Kills 85% of ticks within 48 hours][Kilis more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

[Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dua! protection (against fleas and ticks)] 

Kills the Deer Tick, which may transmit Lyme Disease 

Kills and Repe!s mosquitoes (the major carrier of canine heartworm disease) 

Monthly application for most effective protection 

!GRC!aims: 

[Contains an Insect Growth Regulator (lGR) to kill flea eggs and prevent flea development for 

[more than 10 weeks] up to [75 days][2.5 months]] 

[Breaks Flea Life Cycle for [more than 10 weeks] up to [75 days][2.5 months] 

[Controls flea reinfestation for [more than 10 weeks] up to [75 days[[2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [!GR] to Break Flea Life Cycle] 

ACCEi?TED 

with COMlllElIlTS 

In I\~ ~"'2di¥'ted Under the Fedi!ml iruJectjclde, 

F'ungtc1de. and Rodentlctde Act. as amended. for the peaUclde 

registered.J¥lder EPA Re~ No. 

2/;;1.4--51;1 

1 

165
App!icator Claims 

[NewJ [applicatorJ 

[NewJ contemporary design 

[brand name] [ApplicatorJ creates a barrier to [help] prevent getting liquid on [your] hands 

[brand nameJ [ApplicatorJ tip parts hair to help [!iquid][applicationJ get down to [the][your][dog's[ skin 

Ergonomically contoured [ergonomic[shape][designJ for easy handling [ease of use] [easy useJ 

For use with [onlyJ[brand name[[disposable][liquid dispensingJ tubes [vials] [cartridges] 

[brand name] [applicator]]hasJ[providesJ[allows forJ[deliversJ better grip 

[brand name]provides] re*closab!e [re*sealab!e] packaging for [easyJ storage 

Closing [the][brand name][applicatorJ door automatically opens the [disposable][liquid dispensing] tube 

[vial[cartridgeJ 

Innovative flea and tick application system [applicatorJ 

[brand name[ [ApplicatorJ [will not drip after opening] 

[brand nameJ [Applicalor[ Won't drip when set down as you go fetch the [your[ dog 

Includes unique [brand] applicator 

Puts the liquid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yours 

Helps prevent applying the wrong spot*on [doseJ [productJ on [toJ the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator[ [DISPENSERJ 

[Easy to useJ Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New [disposable][liquid dispensing[ tube Jcartridge][vial[ 

[New] Jbrand namelldisposable][liquid dispensingJ JtubeJ[vialJ tip [helps][to] spread out liquid [on your][dogJ 

Unique [cartridge] [tube][viaIJ with flow control 

Jno drip][no messJ[application][tubeJ[cartridgeJ[vial] 

Promotional Package Copy 

One month [dose] free 

One free month supply [dose] included 

Bonus pack 

Free [applicator][tube][vial[cartridgeJJ[inside[ 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with JbrandJ applicator 

Applicator [deviceJ not included 

[brandJ Refill Pack [brand][applicatorJdevice] not included] 

Refill Claims 

For use [only] with [brand name][ApplicatorJ 

([1TI314[[6] monthly treatments] [1][314][6] Months Supply [24][48] doses 

Easy to use [convenientJ refills 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Applicator Device 

Application Tool 

2 

166
Thermoform name options (tube, cartridge and via] are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6), ............................................................... 5.0% 

OTHER INGREDIENTS: .................................................... .. ..................... 61.4% 

TOTAL 100.0% 

*[bulyl carbityl) (6-propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: One: 1.5 cc [vial][lube)[cartridge] (Toy Dogs)/ 

3.0 cc [vial] [tube)[cartridge] (Small Dogs)! 

4.5 cc [vlal)[tube)[cartridge](Medium Dogs)! 

6.0 cc [vial)[lube)[cartridge] (Large Dogs) 

9.0 cc [vial)[lube][cartridge] (Extra Large Dogs) 

EPA Reg. No. 2724~XXX 

EPA Est. No. 

[ICON - DO NOT USE ON CATS] 

3 

167
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your 

veterinarian immediately. 

[RF2164 AIT COMBO) prevents flea eggs from developing into adult fleas [more than 10 

weeks) for up to [75 daysJ[2.5 months). RF2164 AIT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.} 

Effective flea & tick control for your dog. 

[brand} provides flea and tick protection for dogs for up to 3D-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks, it also prevents 

reinfestation by knocking out flea eggs and larvae that CQuld hatch later on. Plus, it kills and repels 

mosquitoes. 

A unique, convenient applicator for you .... 

The new [brand} Applicator is specially designed to make applying flea and tick control easier, more 

precise -- and neater - than ever before. You simply insert the appropriate [brand] tube 

[vialJ[cartridge] for your dog into the applicator, close it and squeeze to apply. The applicator's 

ergonomic, contoured shape [designJ makes it easy to grip and a built-in fin [tipJ [comb] helps to 

spread [part) the [your) dog's hair to allow the liquid to more readily [better) reach [apply) the [to) [your 

dog's] skin. The tube [vialJ[cartridgeJ is sealed inside, so you can be confident that the liquid goes 

onto your dog - and not your hand. Plus, if the applicator is laid down on a table, counter or other flat 

surface, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

USE RESTRICTIONS: 

The maximum application rate for this product is twice per month, and the second application 

must be made more than 8 days after the initial application. 

RF2164 AIT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube]vial][cartridge] per dog per application)] 

The RF2164 A/T COMBO provides a unique applicator device that allows dog owners to treat 

their dogs more securely, and dispose of nquid cartridges [tubes]]vials]with less mess. 

[Note: Each package contains sufficient cartridges/tubes/vials for [XJ applications] 

[Note: This label contains alternate, independent sets of Directions For Use, which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open, Load, Close, Apply, Dispose, Retreat If Necessary, so the minor 

differences relate to device features. Potential icon designs are on the last pages of 

this document. Text appearing on icon pages is for illustrative purposes only and does 

not represent full text as indicated in DFU which will appear on labeJ.] 

4 

168
[DFU Set No.1] 

FOR [TOy][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge 

[tube][via~[for each application] with the applicator device. 

t. OPEN [icon] 

Holding the applicator device in one hand, push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [vialJ[tube] in the applicator device, ensuring that the 

cartridge [vial]]tube] fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid] cartridge 

[viaIJ[tube] will automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 AlT COMBO evenly to [two 

spots](toy dogs)[three spots](small dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot, use the tip of the applicator device to part the 

hair until the skin is visible. Then push down on the round [circle][button][thumb pad] to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2 t64 AIT COMBO by hand over the dog. Although the dog's skin and hair 

oils will naturally distribute the application over the entire dog, brushing the dog t2-24 hours 

after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side [buttons together] to open 

applicator device door and discard empty cartridge jtube][vial] into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in original package.] 

6. RETREAT IF NECESSARY. Do not reapply product for 30 days unless re-treatment is 

required, but not sooner than 8 days after the initial treatment. Do not retreat more than 

once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1 

2 

3 

4 The dog should be standing for easy application. Apply RF2 t64 AIT COMBO evenly to 

four or five spots on the top of the back from the shoulder to the base of the tail. At each 

spot, use the tip of the applicator device to part the hair until the skin is visible. Then push 

down on the round jcircle][button][thumb pad] to dispense a portion of the solution on the 

skin. Do not apply an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. Do not spread RF2 t64 AIT COMBO by 

hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to 

distribute the material over the skin. 

5 

6 

5 

169
[DFU Set No.2] 

FOR [TOY][SMALL][MEDIUM] SIZE DOGS 

To apply the [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

[for each application] with the applicator device. 

1. OPEN [icon] 

With green door facing downward, push side [buttons] to open applicator. 

2. LOAD [icon] (3 alternate statements) 

-[To Load, insert tube [cartridgeJ[viaIJ [color side downJ[white side up]. Press down on tube 

[cartridge][vial][ until [two green] tabs click in place]. 

-[To Load, place tube[cartridgeJ[vial]under the [color, e.g. green] tabs] [in the applicator] 

-[To Load, place tube[cartridgeJ[vial] white side up into the applicator] 

[Ensure that tube [cartridgeJ[viaIJ fits securely in the applicator.] 

3. CLOSE [icon] 

Point tip up and close the [color, e.g. green] door. The tube [cartridge][viaIJ will snap open and is now 

ready to apply. 

4. APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green door] [Press round thumb pad] once at each of [two] (Toy dogs) [three] 

(Small Dogs)(Medium dogs) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 AlT COMBO by hand over the dog. 

Although the dog's skin and hair oils will naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment w'lll help to distribute the material over the skin. 

5. DISPOSE [icon] 

Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. RETREAT IF NECESSARY 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1 .. . 

2 .. . 

3 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green doorJ[Press round thumb pad] once at each of four or five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 AlT COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5 ... 

6 

6 

170
[DFU Set No.3] 

FOR [TOy][SMALLllMEDIUM]DOGS 

To apply the [RF2 t64 AfT COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

[for each application] with the applicator device. 

1. OPEN ]icon] 

Use finger scoop to lift open door. 

2. LOAD [icon] (2 alternate statements) 

-[To Load, place tube [cartridge][vial]under the [color, e.g. green] tabs ][in the applicator] 

-]To Load, place tube [cartridge][vial] white side up into the applicator] 

[Ensure that tube [cartridge[[vial] frts securely in the applicator.] 

3. CLOSE [icon] 

Close the [color, e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circie] [[round] thumb pad] on green door once at each of [two] (Toy dogs) [three] (Small 

Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that CQuid cause some of the solution to run off 

the side of the dog. Do not spread RF2 t64 AfT COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12~24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

To dispose of empty tube, open [color, e.g. green[ door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. RETREAT IF NECESSARY 

Do not reapply product for 30 days unless re-treatment is required, but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] 

FOR [LARGEllEXTRA LARGE] DOGS 

t 

2 .. . 

3 .. . 

4 APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press ]circle] ][round] thumb pad] on green door once at each of four or five evenly placed spots 

between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any 

one spot that could cause some of the solution to run off the side of the dog. Do not spread RF2164 

AlT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

application over the entire dog, brushing the dog 12-24 hours after treatment will help to distribute the 

material over the skin. 

5 .. . 

6 .. . 

7 

171
RF2164 Aff COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2 t64 NT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2 t64 AIT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosaae: 1 rcartrida~·l·riub~ir~i,;ji everv 30 davs erdoo 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From 1") (30 Days From 2nd) 

Reminder. I purchased RF2164 AJT COMBO from. _______ _ 

NOTES:~~_~ __ _ 

Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial][tube] Disposal: If empty: Do not reuse cartridge [vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For external use only. Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the application site. If signs persist 

or become more severe, contact veterinarian immediately and report incident to company at 

1-800-XXX-XXXX. 

FIRST AID 

If in eyes • Hold eye open and rinse slowly and gently Vllith water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

8 

172
WARRANTY AND CONDITIONS OF SALE: 

Seller warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable law, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantabiHty and fitness for 

the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seller shall have no liability for consequential damages. 

In case of emergency or for product information, call 1-800-xxx-xxxx or contact your 

veterinarian jf your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, "'inois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBE/CARTRIDGENIAL 

Product name 

Etofenprox 30%, (S)-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-XXX 

Net Contents 

[ICON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12 Ibs.), Small (13-31 Ibs.), Medium (32-55 Ibs.), Large (56 -80 Ibs.), and 

Extra Large (81 Ibs. and over) Dogs 6 months of age or older 

9 

173
[SUB-LABEL FOR REFILL CARTRIDGES] 

[Product Name] 

[Flea & Tick [& Mosquito][Treatment] [and] Contral[ 

Spot~On Flea & Tick Control for Dogs 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)" ............................................................... 5.0% 

OTHER INGREDIENTS: .............................................................................. 61.4% 

TOTAL 100.0% 

*(bulyl carbityl) (6-propylpiperonyl ether) and related compounds 

EPA Reg. No. 2724-XXX 

EPA Est No. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

[Note: full directions for use to be used jf space allows] 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this product 

label. 

To apply the RF2164 AIT COMBO treatment, use one disposable liquid cartridge 

[tube][vial][for each application] with the applicator device, 

Remove one refill tube [cartridge][vial] from the package and insert into opened [brand name[ 

applicator device. Make application according to label directions supplied with the [brand 

name] applicator device. If you need directions for application, please call 1-800-XXX-XXXX. 

(Precautionary and Storage/Disposal) text included) 

Wellmark International 

1501 East Woodfield Road 200W 

Schaumburg, Illinois 60173 

10 

174
Alternate Sets of ICONS for the RF2164 AlT COMBO 

[ICON SET 1] 

[OPEN] 

[LOAD] 

'" [CLOSE] 

[APPLy] 

[DISPOSE] 

11 

175
[ICON SET 2) ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

To LOAD Place tube with 

WI-lrrE side UP inte) applicator I 

Close the green door and 

the tube 1/,1111 snap open. 

To APPLY Use TIp to parttur 

and get next to dog's skin. 

Press drde on green door 

once at each of -# spots 

between shoulders 

and tal! 

DISPOSE of empty tube 

two side buttons to 

and 

tube 

("#Spots" is a variable dependent on size) 

(Alternate LOAD icon) 

To LOAD place tube WHITE skle UP 

~erthe_:~7n tatB 

·.~I! / 

c::' 

CLOSE the green door 

and the tube will snap open. 

1 

176
[ICON SET 3) ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

Use linger scoop to lift OPEN door 

I 

CLOSE ltle green door 

and the tube WIll snap open. 

once at # spoIs 

between shoulders 

aM tail 

("#Spots" Is a variable dependent on size) 

2 

177
Well mark Pet Topical Device 

Wade Britton to: Kevin Sweeney, Kimberly Nesci 

Cc: Alexandra laMay 

From: Wade Britton/DC/USEPAIUS 

To: Kevin Sweeney/DC/USEPAlUS@EPA, Kimberly Nesci/DC/USEPAlUS@EPA 

Cc: Alexandra LaMay/DC/USEPAlUS@EPA 

Wade Britton Wellmark Pet Topical Device 

10/281201010:20 AM 

Kevin! Kimberly ~ I wanted to touch base with you guys and offer HED's thoughts on the new pet topical 

device that was presented to us by Wellmark. Allie Lamay and I took the topic to our Exposure SAC and 

we directed an open discussion regarding the device. The ExpoSAC concurred that there is not a need 

for an additional qualitative human health risk assessment for the currently registered product due to the 

proposed change. They agreed that the device does not reduce exposure potential for the applicator; at a 

minimum it is equivalent to the current method and may have the potential to increase risk. Many thought 

that the new device could create a new exposure scenario because of the potential for ai to accumulate 

with each application, in effect, becoming a sink for pesticide residue. However, there is no data or 

means by which to quantitatively assess this new exposure scenario. Likewise, any assessment of risk 

potential from the new device would be qualitative and speculative at best. In sum, most who attended 

ExpoSAC viewed the device not a means to reduce human health exposure potential and instead as a 

marketing tool which could have the unintended effect of increased risk. A few questioned how the new 

device differed from other currently marketed application methods (e.g., pump spray, backpack) which 

would be reused by homeowners. 

What is RO's take? 

Wade 

Wade Britton, MPH 

Industrial Hygienist Health Effects Division 

Office of Pesticide Programs, US EPA 

(703)308-0139 

ills CC (l:,D lV~J- ~ 

K6()'O 

178
Re: Spot On Applicator Question [j 

Wade Britton to: Kevin Sweeney 09/22f2010 10:45 AM 

Cc: Kimberly Nesci, Alexandra LaMay 

From: Wade BrittonlDCfUSEPAlUS 

To: Kevin Sweeney/DCfUSEPAfUS@EPA 

Cc: Kimberly NescifDC/USEPAlUS@EPA, Alexandra LaMayfDClUSEPAlUS@EPA 

Wade Britton Spot On Applicator Question I 

Kevin Sweeney 2724~796 Kevin J. Sweeney, Senior Entom%gist u.s. Environmenta/l 

I 

J Original etofenprox risk assessment for pets was done by Jack Arlhur.1 i 

l~ 

Kevin Sweeney 

Wade Britton 

, 

Thanks Kevin. Ilooked over Jack's risk assessment and it is apt 

Thanks Kevin. I looked over Jack's risk assessment and it is appropriate based upon current standards. 

So, no new RA required. Allie and I will direct discussion of the new application device to the ESac and 

keep you guys posted on what comes out of the mix. 

Wade 

Kevin Sweeney Odginai etofenprox risk assessment' for pfifs wa ... 

From: 

To: 

Cc: 

Date: 

Subject: 

Kevin SweeneyfDCfUSEPAlUS 

Wade BrittonfDCfUSEPAlUS@EPA 

Kimberly NescifDCfUSEPAlUS@EPA 

09f22J20 to to:37 AM 

Re: Spot On Applicator Question 

091221201010:37:44 AM 

Original etofenprox risk assessment for pets was done by Jack Arthur. You may wish to discuss with Jack, 

He did the one for Pet Logic. I think it may have been used for Well mark products but I can't remember 

off~hand. 

Kevin J. Sweeney, Senior Entomologist 

U.S. Environmental Protection Agency 

Office of Chemical Safety and Pollution Prevention 

Office of Pesticide Programs 

Registration Division (7505P) 

1200 Pennsylvania Avenue, NW 

Washington, D.C. 20460~0001 

+1 703305 5063 

Wade Britton Kevi'n ~ "We' in HED would like to know to what p ... 09/221201010:19:32 AM 

179
From: 

To: 

Cc: 

History: 

I 

Spot On Applicator Question 

Wade Britton to: Kevin Sweeney 

Cc: Kimberly Nesci 

Wade Britton/DC/USEPAIUS 

Kevin Sweeney/DC/USEPNUS@EPA 

Kimberly Nesci/DC/USEPAlUS@EPA 

This message has been replied to. 

Wade Britton Spot On Applicator Question 

09/22/201010:19 AM 

Kevin Sweeney 

I 

2724-796 Kevin J. Sweeney, Senior Entomologist u.s. Environmental I 

Kevin Sweeney 

Wade Britton 

Original etofenprox risk assessment for pets was done by Jack ArthUr.J' 

Thanks Kevin. I looked over Jack's risk assessment and It Is a~1 

Kevin - We in HED would like to know to what products (names, reg no., active) the new external 

applicator device would apply, We intend to generate discussion within our Exposure Science Advisory 

Council regarding how to assess risk from the applicator. On a separate note, we wanted to look back at 

the risk assessments conducted for the registered product to which this would apply and make sure they 

are up to date. 

Thanks, Wade 

Wade Britton, MPH 

Industrial Hygienist Health Effects Division 

Office of Pesticide Programs, US EPA 

(703)308-0139 

180
FW: September 15 Meeting Notes 

James McFadden 

to: 

Kevin Sweeney 

10105/201001:04 PM 

Cc: 

Steve Spaulding 

Show Details 

Kevin -

As far as I can tell, we have not received any notes from you on: 

• whether this product will need HED review and 

Page 1 of2 

• what you think the PRIA category will be (assuming we only confirm that the delivered dose is the same 

as the existing product, as suggested by Kimberly). 

Is there any additional feedback that you can share with us? 

Thanks, 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

From: James Mcfadden 

sent: Monday, September 20, 2010 4:23 PM 

To: 'Sweeney.Kevin@epamail.epa.goy'; Gebken.Riclwrd@epamail.epa·,9,o.v 

~J:;: Steve Spaulding 

Subject: September 15 Meeting Notes 

Richard, Kevin: 

The following represents our notes from the EPA Meeting with Wellmark International of September 15, 2010 to 

discuss a new Applicator Concept. 

Attendees: 

EPA: 

Kevin Sweeney 

Wade Britton 

Alexandra LeMay 

Kit FalWell 

Richard Gebken 

Kimberly Nesci 

Byron Backus 

Well mark International 

Steve Spaulding 

Steve LeVeau 

James McFadden 

After introductions, Steve Leveau discussed findings of Well mark's consumer research; documenting concerns 

consumers had about the use of current spot-on products. He then introduced the new applicator concept, and 

showed how it addressed many of the consumer concerns. Key benefits were expressed that the product was 

easier to apply with the applicator, it would help address mis-application to cats and could be stored easily. 

In discussion, EPA suggested that: 

file:/IC:IDocuments and SettingslksweeneylLocal SettingsITemplnotesFCBCEEI-web442... 3114/2011 

181
- Potential human exposure was probably the same as with the current products - no new human risk 

assessment would be needed. 

Page 2 of2 

- The re-use of the applicator may need to be discussed (internally) to determine how to (qualitatively) address 

potential residues on the applicator. This appeared to be an issue for pet exposure, not human exposure. 

- There was significant discussion around the issue of the amount delivered by the applicator, whether it was the 

same as the current product and whether it would be the same in multiple applications. EPA expressed a desire 

to have specific confirmation that the delivery rate would be the same as the current product. 

In discussion about the data requirements and likely PRIA category: 

- Wellmark suggested that the formula was the same as the existing product, the dose and efficacy would be the 

same, and so it was possible the application could contain only a new label and no data - this would place it in 

PR1A Category R300. 

- EPA was not clear about how the confirmation of delivery volume would be submitted. If submitted in a report, it 

would require assignment of an MRID#, and the application would then likely be assigned to PRIA Category 

R310. If submitted as part of the cover letter, the application may still be able to be assigned to PRIA Category 

R300. The PRIA category could also be affected if HED review would be required. 

EPA suggested that this issue could be presented in their PRIA discussion forum to determine how the 

application should be handled. Kevin Sweeney agreed to attend the internal meeting on PRIA categories. 

- The proposed applicator could also be presented at another internal meeting to discuss risk assessment issues. 

Wade Britton agreed to discuss the applicator at this meeting to determine how risk assessment issues would 

likely be handled (and whether HED review would be required). 

- EPA agreed it was possible to have refill packs as a sub-label to the applicator product. (Although it appeared it 

could also be submitted as a separate product.) Thus there would be one new federal registration, and the 

master label for that product would contain directions for the applicator and the refill would be a sub-label. 

EPA made one final request that, if possible, they would like to look at any consumer research that we could 

share with them. It may be useful as general background information. Wellmark agreed to review and send what 

they could. 

Meeting closed with thanks to EPA participants for their time and effort. 

Please let me know if you have comments or corrections to these notes and thank you again for your time and 

assistance. In addition, we would appreciate if you can share any conclusions reached after additional internal 

EPA discussion(s). 

Regards, 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

Disclaimer: TIlis communication and any attachments contain private, confidential, privileged and/or proprietary information intended solely for the 

Recipient(s) named above. If you are not !he in!ended Recipient, any use, dissemination, distribution or copying of the communication is strictly 

prohibited. If received in error, we apologize and ask that you please notify the Sender by returning this e·mail and permanently deleting this 

communication from your computer, including destruction of any printed copies. Any views expressed herein are not necessarily those of the Company 

represented by this e-mail source. No contracts. agreements or legalty binding understandings may be entered into solely by an e·mail communication 

file:IIC:\Documents and SettingslksweeneylLocal SettingsITemplnotesFCBCEEI-web442... 3114/2011 

182
Wellmark" 

January 3, 2011 

R. Gebken, PM 13 

Registration Division 

Document Processing Desk 

Office of Pesticide Programs (7505P) 

U.S. Environmental Protection Agency 

Room S~4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington V A 22202 

James McFadden, Ph.D. 

Wellmark Internalional 

Subject: Response to EPA E-MaiJ of January 3, 2011, Clean labels for EPA New 

Product Application, EPA File SymhoI2724-IRR, RF2164 Arr COMBO 

Dear Mr. Gebken: 

Enclosed with this letter please find printed labels as requested in E-mail from Kevin Sweeney on 

January 3, 2011. These labels support the RF2164 Arr COMBO Application. 

Please let me know if you have any questions or require further information regarding this application, and 

thank you for your assistance. ' 

Regards, 

~~?~...-/".;.;;~~~ ~~~7 

James McFadden, Ph.D. 

Sr. Regulatory Project Manager 

Page 1 of I 

183
RE: 2724-IRR 

James McFadden to: Kevin Sweeney 01/03f2011 01 :44 PM 

History: This message has been replied to. 

Kevin Sweeney 2724-IRR 

James McFadden Kevin - We submitted a revised label directly to the reviewer and it waJ 

Kevin Sweeney 

- ,~-.. -~ .... ". -'I 

Kevin -

We submitted a revised label directly to 

the label that was originally submitted. 

needed for review. 

The product chern issues were: 

the reviewer and it was swapped with 

What you should have now is what is 

1) The Data Matrix is missing guideline 830.1550, Product Identity & 

Composition (which is required for this application) (We said this is 

fulfilled by the CSF) 

2) The inert ingredient, is listed on the Alternate 

Formulation under a trade name that is not currently 

recognized. 

(We submitted a revised CSF) 

For your reference, I have attached the correspondence that I sent him. 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

-----Original Message-----

From: Sweeney.Kevin@epamail.epa.gov [mailto:Sweeney.Kevin@epamail.epa.gov] 

Sent: Monday, January 03, 2011 12:14 PM 

To: James McFadden 

Subject: 2724-IRR 

Importance: High 

Were you able to resolve the deficiencies with the front end screen? I 

am reviewing the submission and it appears there was a label problem and 

some product chem reference issue? I am trying to find S. Schaible or 

R. Gebken to discuss this but if you have info I'd appreciate it as I 

need to get this in review. 

kevin 

184 *Inert ingredient information may be entitled to confidential treatment*
Kevin J. Sweeney, Senior Entomologist 

U.S. Environmental Protection Agency 

Office of Chemical Safety and Pollution Prevention 

Office of Pesticide Programs 

Registration Division (7505P) 

1200 pennsylvania Avenue, NW 

washington, D.C. 20460-0001 

+1 703 305 5063 

Disclaimer: This communication and any attachments contain private, 

confidential, privileged and/or proprietary information intended solely for 

the Recipient(s) named above. If you are not the intended Recipient, any use, 

dissemination, distribution or copying of the communication is strictly 

prohibited. If received in error, we apologize and ask that you please notify 

the Sender by returning this e-mail and permanently deleting this 

communication from your computer, including destruction of any printed copies. 

Any views expressed herein are not necessarily those of the Company 

represented by this e-mail source. No contracts, agreements or legally 

binding understandings may be entered into solely by an e-mail communication 

----- Message from James McFadden <jmcfadden@central.com> on Wed, 8 Dec 2010 07:53:20 -0800 -----

T "Clausen.Kirk@epamail.epa.gov" 

0: <Clausen.Kirk@epamail.epa.gov> 

Subject FW: Label for 2724.IRR 

Final label attached. Again, thank you for your assistance 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

-----Original Message-----

From: James McFadden 

Sent: Wednesday, December 08, 2010 9:52 AM 

To: 'Clausen.Kirk@epamail.epa.gov' 

Subject: RE: Label for 2724-IRR 

Kirk -

Final Label attached. Again, thank you for your assistance 

James McFadden 

Sr. Regulatory project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

-----Original Message-----

From: Clausen.Kirk@epamail.epa.gov (mailto:Clausen.Kirk@epamail.epa.gov] 

Sent: Wednesday, December 08, 2010 7:22 AM 

To: James McFadden 

Subject: Re: Label for 2724-IRR 

185
Required: 

Descriptio~l : 

Agenda: 

Kevin -

Meet with Well mark on pet topical delivery device 

Calendar Entry 

Wed 0911512010 11'.00 AM - 12:00 

PM 

Rooms: RD Small Conference Room D (S-7771)/Potomac Yard One@EPA 

RD Small Conference Room E (S~7731)/Potomac Yard One@EPA 

Alexandra LaMay/DC/USEPAlUS@EPA, Byron Backus/DC/USEPAlUS@EPA, Deborah 

McCafflDC/USEPAlUS@EPA, Kimberly Nesci/DC/USEPAlUS@EPA, Kit 

FarwefflDC/USEPAlUS@EPA, Richard Gebkerv'DC/USEPAlUS@EPA, Wade 

For tomorrow's meeting on the pesticide applicator presentation, the following represents our proposed 

agenda: 

• Agenda: 

• Introductions 

• Marketing Presentation for Proposed Applicator 

(Concept, Features and Benefits) 

• Discussion of Regulatory Requirements 

(Is it a device, PRiA Categmy, Data Required, EPA Response, 

• Wrap Up (Brand Names, Miscellaneous issues) 

• Objectives 

• Present a new applicator concept and address any EPA concems 

• Determine requirements for regulatory submissions 

As I think we mentioned previously, the attendees from our side are: 

Steve Spaulding, Director of Regulatory Affairs 

Steve LeVeau, Sr. Marketing Manager, Companion Animal Health 

(And me). 

Thank you for your assistance 

James McFadden 

Sr. Regulatory Project Manager 

Well mark International 

Centra! Life Sciences 

Tel: 847-330-5369 

Wellmark would like to request a pre-submission meeting for a rather 

unique type of pesticide device. 

As you know, they have an etofenprox/methoprene dog topical (EPA Reg. No. 

2724-796, RF2042 eDSO) whi~h is currently in the market. 

Their marketing group has proposed a new applicator for the formula, which 

186
we expect would be treated as a device. (The existing liquid containers 

for the topical would stay·the same or be modified only slightly.) 

If sold with the topical solution, our understanding is that the device 

would require registration, and they would like to understand what the EPA 

would want to see in a submission to register an applicator device for 

pet topicals. (Especially given the recent sensitivity of EPA in 

regards to these products, we are not sure what the EPA would want to 

see in regards to this applicator.) 

Without going into a lot of detail here, (and please treat this as CEI) 

They will have diagrams, draft Directions for Use, and we hope to have a 

prototype available for review. 

187 *Commercial/financial information may be entitled to confidential treatment*
REGULATORY LABEL DATA SHEEl 

File Name: 

Product: 

Approved: 

OVERVIEW: 

Page # 

1 

2 

3 

RF2164 AfT COMBO 

RF2164 AfT COMBO 

Data Sheet Date: 

EPA Reg #: 

Supercedes: 

For Applicator and Topical Combo 

November, 2010 

7/10 FPL + DCI Changes + Risk Mitiga1ion + Applicator Directions 

Description of Major Changes 

Ingredient Statement: Per DCI, revised PBO asterisked statement 

Directions for Use: Added Use Restrictions per DCI 

Addi1ional marketing claims, revised DFU based on consumer testing 

1 

188
RF2164 AfT COMBO 

[Text for "Dog" must be same size as Brand Name] 

Front Panel- ForUse Only on Toy (6-12Ibs.), Small (13-31 Ibs.), Medium (32-55 Ibs.), Large (56 -80 

!bs.), and Extra Large (81 Ibs. and over) Dogs 

Front Panel- ForUse Only on Dogs 6 months of age or o!derJ 

[Flea &. Tick [& MosguitolJTreatmentJ [and] Contron 

Spot-On Flea &. Tick Control for Dogs 

General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 

5 size categories provide tighter fsma!!erlweight ranges to improve [maintainlfdeliverJ efficacy 

[performancel[flea and tickJrcontrolJ[protectionl and to help reduce the risk of adverse reactions on [for] 

your dog 

Effective on indoor and outdoor dogs 

([1][3][4][6] monthly treatments) [1][3][4][6] Months Supply]24][48] doses 

Spreads naturally with dog's movement (skin and hair oils) 

]Formula][Contains lanolin for coat conditioning} 

]Water Resistant]]to keep killing fleas and ticks in humid and wet conditions] 

]Fast Acting][Long LastingTIKills Fleas and Ticks by Contact] 

[FreshllClean][[Scent][Smell] 

[Reapply monthly} ]Suitable for year-round use][Month] sticker for home calendar 

[Satisfaction guaranteed or your money back] 

[Patent PendingJ 

Efficacy Claims: 

Each tube [cartridgeUvial] [application} [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 

3 to 4 weeks] 

[Protects for up to [Four/4] Weeksj[One month][Four/4 Week ]Flea}rrick][Mosquito] Treatment] 

[Aids in Control of Ticks for up to 30 days] 

[Starts Killing Fleas and Ticks within t5 minutes] 

[Starts working in 15 minutes [lasts UP to 30 days] 

[Kills 85% of ticks within 48 hours]]Kills more than 50% of fleas in 2 hours] 

[Dual Action kills adult fleas and prevents flea development] 

] Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection (against fleas and ticks)] 

Kills the DeerTick, which may transmit Lyme Disease 

Kills and Repels mosquitoes {t.b.§ major carrier of canine heartworm disease) 

Monthly application for most effective protection 

IGRClaims: 

{Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for 

[more than to weeks} up to [75 days]2.5 monthsll 

[Breaks Flea Life Cycle for]more than 10 weeks} up to [75 days][2.5 months} 

]Controls flea reinfestation for [more than 10 weeks] up to [75 days][2.5 months] 

[With [S-Methoprene] Insect Growth Regulator [IGR} to Break Flea Life Cycle] 

1 

189
Applicator Claims 

[New] [applicator] 

[NewJ contemoorary design 

[brand name] [Applicator] creates a barrier to [helP] prevent getting liquid on [yourJ hands 

[brand name) [Applicatorl tip parts hair to help fliquid][applicationJ get down to ftheJfyourlfdog'sJ skin 

Ergonomically contoured femonomiclfshapelfdesign] for easy handling [ease of use} [easy use] 

For use with fonlyl[brand namelfdisoosablelfliquid dispensing] tubes [vialsJ [cartridges1 

ibrand namellappl1:catorllhas)IDrovides]fallows forlfdelivers) better griP 

[brand name]forovides] re-closable [re-sealable] packaging for [easy] storage 

Closing ftheJ[brand nameJfaoplicatorJ door automatically opens the fdisposablelfliguid dispensing] tube 

[viaOfcartridqe1 

Innovative flea and tick application system [applicator] 

[brand name] [Apolicator] [will not drip after opening] 

[brand name] [Applicator) Won't drip when set down as you go fetch the [your] dog 

Includes unique [brand] applicator 

Puts the liauid on your dog - not your hands 

Directs the liquid onto your dog - not your hands 

Directs the liquid onto your dog - away from your hands 

Applies liquid to your dog's skin - not yOurs 

Helps prevent applving the wrong soot-on [dose] [productl on [to] the wrong pet 

Convenient, easy to use ACCU-TIP [Applicator] [DISPENSERl 

[Easy to use] Longer applicator tip for easy application to long-haired dogs 

Thermoform claims 

New 

New [disposablel[liquid dispensing] tube [cartridgeJ[viall 

[New] [brand namelfdisoosablelfliguid dispensing] ftubeJ[viall tip [helpslftoJ spread out liquid [on yourlfdogJ 

Unique [cartridqe] [tubelfvialJ with flow control 

[no driplfno mess][applicationlftubel[cartridgelfviall 

Promotional Package CoPY 

One month [dose] free 

One free month suoply [dose] included 

Bonus pack 

Free [applicatorUtubeIfvialEcartridgeIlfinsidel 

Designed not to drip when set on top of the counter, or table, or other flat surface. 

For use with [brand] applicator 

Applicator [device] not included 

[brand] Refill Pack fbrandlfapolicator [device] not included] 

Applicator name options (applicator device is used in text) 

Applicator 

Tool 

Device 

Apolicator Device 

Aoolication Tool 

2 

190
Thermoform name options (tube. cartridge and vial are used in the text) 

Ampoule 

Cartridge 

Packet 

Pod 

Refill 

Tube 

Vial 

ACTIVE INGREDIENTS: 

Etofenprox (CAS # 80844-07-1) .................................................................... 30.0% 

S-Methoprene (CAS # 65733-16-6) .................................................................. 3.6% 

Piperonyl Butoxide (CAS # 51-03-6)' ............................................................... 5.0% 

OTHER INGREDIENTS: ................................................................................ 61.4% 

TOTAL 100.0% 

'{butYLcarbityQ (6·propylpiperonyl ether) and related compounds 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See Back Panel for [Ingredients and] Additional Precautionary Statements 

NET CONTENTS: One: 1.5 cc [vialJ[tubelcartridgeJ (Toy Oogs)/ 

3.0 cc[vian [tubeJcartridgeJ (Small Oogs)/ 

4.5 cc [vian[tubeIcartridge1(Medium Dogs)/ 

6.0 cc [viafJ[tubelcartridgeJ (Large Dogs) 

9.0 cc [vialJ[tubelcartridgeJ (Extra large Dogs) 

EPA Reg. No. 2724-XXX 

EPA Est. No. 

[ICON - DO NOT USE ON CATS] 

3 

191
RF2164 AfT COMBO 

IMPORTANT! DO NOT Use on Dogs LESS THAN 6 Months OLD 

READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS. DO NOT USE ON 

OTHER ANIMALS! 

[Back Panel] 

DO NOT USE ON CATS 

Keep cats away from treated dogs for 24 hours. If applied or ingested. contact your 

veterinarian immediately. 

[RF2 t64 AfT COMBO] prevents flea eggs from developing into adult fleas [more than to 

weeks] for up to [75 days][2.5 months]. RF2164 AfT COMBO also kills fleas and ticks for 3 

weeks and kills and repels mosquitoes for 3 to 4 weeks.] 

Effective flea & tick control for your dog. 

[brand] provides flea and tick protection for dogs for UP to 30-days - and protection from flea 

reinfestation beyond. That's because it doesn't just kill adult fleas and ticks. it also prevents 

reinfestation by knocking out flea eggs and larvae that could hatch later on. Plus. it kills and repels 

mosquitoes. 

A unique. convenient applicator for you .... 

The new [brand] Applicator is specially designed to make applying flea and tick control easier. more 

precise u and neater - than ever before. You simply insert the appropriate [brand] tube 

[vial][cartridgeJ for your dog into the applicator, close it and sgueeze to apply. The applicators 

ergonomic, contoured shape [design] makes it easy to grip and a built-in fin [tiP] [comb1 helps to 

spread [part1 the [Your] dog's hair to allow the liquid to more readily [better] reach [apply] the [to] (Your 

dog's] skin. The tube [vialUcartridgel is sealed inside, so you can be confident that the liquid ooes 

onto your dog and not your hand. Plus, if the applicator is laid down on a table. counter or other flat 

suriace, it won't run out or drip. 

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner 

inconsistent with its labeling. Read and follow all directions and precautions on this oroduct 

label. 

USE RESTRICTIONS: 

The maximum application rate for this product is twice oer month, and the second application 

must be made more than 8 days after the initial application. 

RF2164 AfT COMBO works by application directly to the dog's skin, not to the hair. When 

applying, use applicator device tip to push aside dog's hair to allow direct application to the 

skin. Do not get this product in dog's eyes or mouth. 

[(Note: Application now assumes one tube[vialJ[cartridqe] per QQR.per application)] 

The RF2164 AfT COMBO provides a unique applicator device that allows dog O\'vners to treat 

their dogs more securely, and dispose of liquid cartridges ftubesJ[vials]with less mess. 

[Note: Each package contains sufficient cartridges/tubeslvials for [X] applications] 

[Note: This label contains alternate, independent sets of Directions For Use. which are 

provided to allow for flexibility in device manufacturing. Each set of DFU has the same 

6 steps: Open. Load, Close, Apply. Dispose. Retreat If Necessary. so the minor 

differences relate to device features. Potential icon designs are on the last pages of 

this document. Text appearing on icon pages is for illustrative purposes only and does 

not represent full text as indicated in DFU which will appear on label.] 

4 

192
1. OPEN [icon] 

Holding the applicator device in one hand. push the side [buttons] to open the device. 

2. LOAD [icon] 

Place one disposable liquid cartridge [via!][tubeJ in the applicator device, ensuring that the 

cartridge [via!][tubeJ fits securely in the slots inside the applicator device. 

3. CLOSE [icon] 

Point the applicator device tip upward and close the lid. The disposable [liquid1 cartridge 

[via!][tubel wi!! automatically be clipped open and is now ready to be applied to your dog. 

4. APPLY [icon] 

The dog should be standing for easy application. Apply RF2164 Aff COMBO evenly to [two 

spots](toy dogs}[three spots](sma!! dogs)(medium dogs) on the top of the back from the 

shoulder to the base of the tail. At each spot. use the tiD of the applicator device to part the 

hair until the skin is visible. Then push down on the round rcircleJrbutton][thumb padl to 

dispense a portion of the solution on the skin. Do not apply an excessive amount of the 

solution at anyone spot that could cause some of the solution to run off the side of the dog. 

Do not spread RF2164 AIT COMBO by hand over the doo. Although the dog's skin and hair 

oils wil! naturally distribute the application over the entire dog. brushing the dog 12-24 hours 

after treatment wi!! he!p to distribute the material over the skin. 

5. DISPOSE [icon] 

When finished, hold applicator device over trash. Push side [buttons together] to open 

applicator device door and discard empty cartlidge ftubeJ[via!J into trash or offer for recycling if 

available. [Close applicator device door and store [applicator device] in origina! package.] 

6. RETREAT!F NECESSARY. Do not reapply product for 30 days unless re-treatment is 

required, but not sooner than 8 days after the initial treatment. Do not retreat more than 

once per month. 

[Note: Each package contains sufficientcartridgesitubesivials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

_1_ 

L 

L 

4 The dog should be standing for easy application. Apply RF2164 AIT COMBO evenly to 

four or five spots on the top of the back from the shou!der to the base of the tail. At each 

spot. use the tip of the applicator device to part the hair until the skin is visib!e. Then push 

down on the round [circ!elfbuttonJrthumb pad] to disoense a portion of the solution on the 

skin. Do not app!v an excessive amount of the solution at anyone spot that could cause 

some of the solution to run off the side of the dog. Do not spread RF2164 Aff COMBO by 

hand over the dog. A!though the dog's skin and hair oils wi!! naturally distribute the 

application over the entire dog. brushing the dog 12-24 hours after treatment will helD to 

distribute the materia! over the skin. 

L 

L 

5 

193
-[DFU Set NO.2] 

1. OPEN [icon] 

With green door facing downward. push side [buttons] to open applicator. 

2. LOAD [icon] (3 alternate statements) 

-[To Load. insert tube fcartridgeJfvialJ [color side downJrwhite side up). Press down on tube 

[cartridgeJ[vialJ[ until [two green] tabs click in place]. 

-[To Load. place tubefcartridgeJfvialJunder the [color. e.g. green] tabs] [in the applicator] 

-[To Load. place tube[cartridge][vialJ white side up into the applicator] 

[Ensure that tube fcartridge]rvialJ fits securely in the applicator.] 

3. CLOSE [icon] 

Point tip up and close the [color. e.g. green] door. The tube fcartridgelfviall will snap open and is now 

ready to apply. 

4. APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to dog's 

skin. [Press circle on green door] [Press round thumb pad] once at each of ftwo] (Toy dogs) [three] 

(Small Dogs){Medium dogs) evenly placed spots between the shoulder and the base of the tail. 

Do not apply an excessive amount of the solution at anyone spot that could cause some of the 

solution to run off the side of the dog. Do not spread RF2164 Nf COMBO by hand over the dog. 

Although the dog's skin and hair oils will naturally distribute the application over the entire dog, 

brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon] 

Push side [buttons] to open door and drop empty tube fvialJ[cartridge] into trash or offer for recycling if 

available. [Close applicator device door and store in original package.] 

6. RETREAT IF NECESSARY 

Do not reapply product for 30 days unless re-treatment is reqUired. but not sooner than 8 days 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubeslVials for [X] applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

1_._ .. 

2~ 

3~ 

4 APPLY [icon] 

The dog should be standing for easy application. To Apply, Use tip to part hair and get next to 

dog's skin. [Press circle on green door]fPress round thumb pad] once at each of four or five 

[evenly placed] spots between the shoulder and the base of the tail. Do not apply an 

excessive amount of the solution at anyone spot that could cause some of the solution to run 

off the side of the dog. Do not spread RF2164 Nf COMBO by hand over the dog. Although 

the dog's skin and hair oils will naturally distribute the application over the entire dog. brushing 

the dog 12-24 hours after treatment will help to distribute the material over the skin. 

5~ 

6~ 

6 

194
Ii 

1. OPEN [icon] 

Use finger scoop to lift open door. 

2. LOAD (icon] (2 alternate statements) 

~[To Load, place tube [cartridgelfviallunder the [color. e.g. green] tabs][in the applicator] 

-[To Load. place tube [cartridgeJ[via!l white side up into the applicator] 

[Ensure that tube [cartridgeJfvialJ fits securelv in the applicator.] 

3. CLOSE [icon] 

Close the [color. e.g. green] door and the tube will snap open. 

4. APPLY [icon] 

The dog should be standing for easy application. To apply, use tip to part hair and get next to dog's 

skin. Press [circle] [[round] thumb padl on green door once at each of [two] (Toy dogs) [three] (Small 

Dogs) (Medium dogs) evenly placed spots between the shoulder to the base of the tail. Do not apply 

an excessive amount of the solution at anyone spot that could cause some of the solution to run off 

the side of the dog. Do not spread RF2164 AJT COMBO by hand over the dog. Although the dog's 

skin and hair oils will naturallv distribute the application over the entire dog, brushing the dog 12~24 

hours after treatment will help to distribute the material over the skin. 

5. DISPOSE [icon) 

To dispose of empty tube, open [color, e.g. green] door and drop empty tube into trash or offer for 

recycling if available. [Close applicator device door and store in original package.] 

6. RETREAT IF NECESSARY 

Do not reapply product for 30 days unless re-treatment is required. but not sooner than 8 davs 

after the initial treatment. Do not retreat more than once per month. 

[Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications] 

FOR [LARGE][EXTRA LARGE] DOGS 

~ 

~ 

~ 

4 APPLY [icon) 

The dog should be standing for easy application. To applv. use tip to part hair and get next to dog's 

skin. Press [circle] [[roundl thumb padl on green door once at each of four or five evenly placed spots 

between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any 

one spot that could cause some of the solution to run off the side of the dog. Do not soread RF2164 

AJT COMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the 

apolication over the entire dog, brushing the dog 12-24 hours after treatment will help to distribute the 

material over the skin. 

~ 

!L.= 

7 

195
RF2t64 AfT COMBO is most effective when used as part of a total flea and tick management 

program. Use other [Brand Name] products registered for residential area control of these 

pests in conjunction with this treatment. Monthly treatments are required for optimal control 

and prevention of fleas. 

[The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder 

known as flea allergy dermatitis (FAD). Treatment of dogs with RF2164 AfT COMBO rapidly 

kills fleas and may reduce the incidence of this condition.] [RF2164 AfT COMBO is water 

resistant and remains efficacious following exposure to rainfall or swimming.] 

TREATMENT SCHEDULE 

Dosage: 1 rcartridael rtubelfviall every 30 davs erdoa 

Pet's Name First Treatment Date Second Treatment Date Third Treatment Date 

(30 Days From t") (30 Days From 2nd

) 

Reminder: I purchased RF2t64 AfT COMBO from: 

NOTES:-:-::-;-;-_-:-___ . Treatment table can be expanded based on package size. (6 months) 

STORAGE and DISPOSAL:. Pesticide Storage: Store in a cool area away from children 

and animals. Liquid Cartridge [vial]ftubeJ Disposal: If empty: Do not reuse cartridge (vial] 

[tube]. Place in trash or offer for recycling if available. If partially filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION 

DO NOT USE ON DOGS LESS THAN 6 MONTHS OLD. For external use only. Causes moderate 

eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Repeated 

exposure to etofenprox can cause skin irritation. Consult a veterinarian before using this product on 

debilitated, aged, pregnant, nursing, or animals on medication. Sensitivities may occur after using 

ANY pesticide product for pets. If signs of sensitivity occur, bathe your pet with mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

Some pets may experience hair loss or temporary skin irritation at the application site. If signs persist 

or become more severe. contact veterinarian immediatelv and report incident to company at 

1-800-XXX-XXXX. 

FIRST AID 

If-in eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

• Remove contact lenses, if present, after first 5 minutes, then continue rinsing 

• Call a poison control center or doctor for treatment advice. 

Have the product container or label with you when calling a pO'lson control center or doctor or going 

for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment 

information. 

8 

196
WARRANTY AND CONDITIONS OF SALE: 

Seiler warrants that this product conforms to the chemical specifications expressed on the label. To 

the extent consistent with applicable Jaw, Seller makes no other warranties, and disclaims all other 

warranties, express or implied, including but not limited to warranties of merchantability and fitness for 

the intended purpose. To the extent consistent with applicable Jaw, seller's liability for default, breach, or 

failure under this label shall be limited to the amount of the purchase price. To the extent consistent with 

applicable law, Seiler shall have no liability for consequential damages. 

In case of emergency or for product information, call 1 M800 M xxx-xxxx or contact your 

veterinarian if your pet is experiencing an adverse event. 

Wellmark International 

1501 E. Woodfield Road. 200W 

Schaumburg, Illinois 60173 

[URL] 

Made in USA 

TEXT FOR LIQUID TUBEICARTRIDGEIVIAL 

Product name 

Etofenprox 30%, (Sl-Methoprene 3.6%, Piperonyl Butoxide 5% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

READ DIRECTIONS BEFORE USING 

EPA Reg. No. 2724-XXX 

Net Contents 

nCON - DO NOT USE ON CATS] 

For Use Only on Toy (6-12Ibs.1. Small (13-31 Ibs.). Medium (32~55Ibs.). large (56 ~80 Ibs'>, and 

Extra large (81 Ibs. and over) Dogs 6 months of age or older 

9 

197
198
Alternate Sets of ICONS for the RF2164 AfT COMBO 

[ICON SET 1] 

[OPEN] 

~ 

[LOAD] 

[CLOSE] 

[APPLY] 

[DISPOSE] 

11 

199
[ICON SET 21 ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

TO APPLY Use 1""'1'10 !>"11m" 

an<! gel """10 dIog'1s __ _ cildleoogmen obr 

0R:e ate:adlof bE spo6 

--

an<!laI 

("#Spots" is a variable dependent on size) 

Alternate LOAD icon 

1 

200
[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size) 

To f4PFiLVUse TipIDpa1fur _get nex!IDOOg's __ 

l!' "lJ<lIIS 

-~ _tail 

("#Spots" is a variable dependent on size) 

2 

201
Tracking 

Create Resubmission 

FFS Letters 

Action Code History 

202
21-Day Screen Completed by 

Contractor 

21-Day Expires on _-,-I_L_-_I-,-<l_-_/=o_ 

Jacket # z 7 '2[/- 1P.r2.. 

MRID# ~ 

Content Screen: ed to 

P « f7 J/E,.,,,,/ 

6-5 Review: A 

Transfer This Jacket to: 

I 

203
PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPA/OPP Use Only) 

3123/09 

21 Day Screen Start Date: ___ ~/uIL------,,273,,---,--I-=O,---____ c:-

Experts In-Processing Signature: "",F IfA'Vt.NV6'OAl Date //- Z. 9-/ 0 Fee Paid: yes/ 

Division management contacted on issues No Yes ____ Date 

EPA Reg. Number: 1. 7?. Lf - I I< 12 EPA Receipt Date: 1/ - 7. :\ 10 

1 

2 

3 

Items for Review 

Application Form (EPA Form 8570-1)(link to form) signed & complete 

including package type 

Confidential Statement of Formula all boxes completed, fonu signed, and 

a) All inerts (link to http://www.epa.gov!opprdOOllincrtsl), 

including fragrances, approved for the proposed uses (see 

Footnote A) 

yes 

Yes No N/A* 

no 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to \r 

form) completed and signed (N/A if 100% repack) /\ 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

If is there a letter of Authorization for exclusive use 

yes 

(EPA Form (Link to form) 

x 

no 

4 completed and signed (N/A if source is unregistered or applicant owns the 

5 

Data Matrix (EPA Fonn 8570~35) (Link to form) both internal and external X 

copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% 

Selective Method 

b) Cite~Al1 (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

5 Copies of Label (link to http://www.epa.gov/oppfeadlllabeling/lrmi) 

6 (Electronic labels on CD are encouraged and guidance is available)( link to X 

http://www.epa.gov/pesticideslregulating/registering/submissions/index.htm #Iabels 

I 

204
7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) X 

Notice of Filing (link to 

8 httQ:/Iwww.eI,!3.gov/Qesticides/reguiatin2/tolerance Qetitions.htm) included 

'X- with petitions (link to 

http://www.epa.gov/pesticides/reguiating/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) X 

Required Data (link to 

h ttl!:/ /www.eQ3.gov/l!esticidesLregulatin I!Idata reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

10 

2 

205
Comments: 

IL~!%,' \ /g D !Vo (>t\Adces c,s.st>c(Cc'ied w! jetciLet 

1.ln e r+- '\f!c\Ced.{,CA-t on 0!-{e.rr;4-t..::::... _(IOCML{lq 

unrCCD~,fiize) ~ 1rc-.Je- nuflA~ ~, 

( 1 f1 en vc (t'-- ;/-c ) 

~I?P ((Cqvt-( i2(C{~(~f:':" 

( sec Cd(0 eke'" 

-d-1/'::.- ~,U;'JC--110r:: 

nl l" J. I" c '-t'\'f ltV-fA, '1<A,_ 

I, n. a f e k:: tA-t 1-&<'1 

'-' 

(C, i L{ t" c---{ c. .J 

(be ~;u! ,,(1 

* NfA - Not Applicable 

Footnotes 

I" ! I \ .s4.e c :Oy 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the CSF, etc. or 2) provide the data to support opp approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All information, fonTIs, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period. otherwise. the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 

206
site [link to http://www.epa.f!:ov/opprdOO]/inerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inelt ingredient web site and the applicant believes that the 

inelt has been approved, the applicant should contact the hlert Ingredient Assessment 

Branch (IIAB) at inertsbranch@epa.f!:ov and resolve the issue. Copies of the 

correspondence with llAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by IIAB. The IIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.cpa.gov/oppbppdI/biopesticides/contactsbprd.htm ] . 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.cpa.gov/opprdOOl/inerts/tips.pdf] must also be included 

to enable the Agency to detennine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants mllst arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

207
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the infonnation and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they nUlst be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 ~day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

208
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similarlidentical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R30 1 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

209
RE: RF2164 AfT COMBO (EPA Reg. No. 2724-IRR) 

James McFadden to: Kirk Clausen 

Dear Mr. Clausen: 

12107/201003:58 PM 

Thank you for your e-mail and follow-up phone call. In response to the issues 

identified below, wellmark responds that: 

1. Guideline 830.1550 is considered fulfilled by submission of the CSF, which 

formally specifies product identity and composition. A Table of Ingredients 

is also included in the Manufacturing and Materials report, even though the 

Guideline is not cited. 

2. A revised Alternate Formula is attached to this e-mail, and addresses the 

trade name issue that was identified by EPA. 

3. As discussed by phone, we request that the attached revised label be 

substituted for the original label that was submitted. If you are able to 

print five copies of the revised label, it should suffice (minor changes 

related to device features and some new icons were added) . 

Please use the attached information to complete the application package, and 

thank you for your assistance. 

Regards, 

James McFadden 

Sr. Regulatory Project Manager 

Wellmark International 

Central Life Sciences 

Tel: 847-330-5369 

-----Original Message-----

From: Clausen.Kirk@epamail.epa.gov [mailto:Clausen.Kirk@epamail.epa.govl 

Sent: Thursday, December 02, 2010 10:06 AM 

To: James McFadden 

Subject: RF2164 AfT COMBO (EPA Reg. No. 2724-IRR) 

James McFadden, 

This is Kirk Clausen, EPA contractor. This email is in regards to your 

submission of in support of RF2164 AfT COMBO (EPA Reg. No. 2724-IRR). we 

have found the following deficiencies regarding the Application Package: 

1) The Data Matrix is missing guideline 830.1550, product Identity & 

Composition (which is required for this application) 

2) The inert ingredient, is listed on the Alternate 

Formulation under a trade name that is not currently 

recognized. 

These deficiencies have been approved by the EPA. The corrections can be 

emailed to me or faxed to 703-305-5060fAttn: Kirk Clausen. If we do not 

receive the corrections by December 8, 2010, we will process your 

submission, accordingly. If you have any questions you may contact me 

via email or by phone at 703-347-8784 (I am typically available by phone 

between 7: OOam and 4: OOpm) . 

Kirk Clausen 

210 *Inert ingredient information may be entitled to confidential treatment*
Environmental Analyst 

Macfadden and Associates 

EPA contract 

Disclaimer: This communication and any attachments contain private, 

confidential, privileged and/or proprietary information intended solely for 

the Recipient(s) named above. If you are not the intended Recipient, any use, 

dissemination, distribution or copying of the communication is strictly 

prohibited. If received in error, we apologize and ask that you please notify 

the Sender by returning this e-mail and permanently deleting this 

communication from your computer, including destruction of any printed copies. 

Any views expressed herein are not necessarily those of the Company 

represented by this e-mail source. No contracts, agreements or legally 

binding understandings may be entered into solely by an e-mail communication 

211
UNITED STATES ENVIRONMENTAL PROTE<.;TION AGENCY 

WASHINGTON, D.C. 20460 

November 26, 2010 

OPP Decision Number: D-442499 

EPA File Symbol or Registration Number: 2724-IRR 

Product Name: RF2164 AIT COMBO 

EPA Receipt Date: 23-Nov-201O 

EPA Company Number: 2724 

Company Name: WELLMARK INTERNATIONAL 

JAMES MCFADDEN, PH.D. 

WELLMARK INTERNATIONAL 

1501 E. WOODFIELD ROAD, SUITE 200 WEST 

SCHAUMBURG,IL 60173 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results oftbe PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R300 

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK; 

No additional payment is due at this time. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerel Z ro~mg: aff 

~ -

chn ogy & Resources Management Division 

212
IFee for Servicel 

J/ 

(886305(-

@ New Registration 

°Amendment 

'Studies? C Fee Waiver? 

II volpay % Reduction: __ 

I~ for Division 

oAD 

OBPPD 

@RD 

Risk Mgr. []I] 

~--::::~-==-.~.-. ==== :::::=~.~-. ====~--.--~-.-.--~~-~::::::~I 

Receipt No. s-I 886305 

EPA File Symbol/Reg. No. 1 2724-IRR 

Pin-Punch Date: 1 11/23/2010 L_._~_ .. _._. __ ~~~_ __ _ .... ~._.~ .. ____ .. ~ .. ~ ____ ._ ..... ~ .. _ ..... ~~~ ___ ~~~ ___ _ _________________ J 

iJ This item is NOT subject to FFS action. ---~~~~.~--

!~---A-ctran-eade:~ ~~,,' Parent/Child Decisions: 

Requested: 

Granted: 

L~~~ Amount Due: $ lei 'Sci e'r , 

[jjj Inert Cleared for Intended Use Uncleared Inert in Product 

/ - /' 

Reviewer:_--""IJ",,(cc.AC'-~,,,L 'CC)LC _i,,-Iu/(cfof,-"?/,-!-i ___ _ . ., ' Date :_i-,II~' 2_~if,-c C 1-'( 1"",-,_ 

Remarks: 

~\c:.{( It> l)fl: S~L{---jL[L( -L'tLL':).- ,:-UL'p'i.i'L,( '.r:-f.[ f'"fh,L---- r::.{-(', (L'-I-'( ____ _ 

~-"tvVi ~L-L'- ~-j~~2Lbi. ;,-\ r'kL-L_: ~ru -lJi_LJ~';-l{ - Cl-__ LiL/vH,,/)~_~ {\/ --fz/:/\-'f~1./--',/ . . \ 

{.~{;l i"Hc,c ;GL'L'- .£'<-1...'--- f.-:)u ..... (L?l( try\. t>rL-' (lL--L{Vl-'-i4 

,ft.:.../ P!2- \/\ ~G{ tVlC JU\ " 

213
R 300 and 301 

100% identical (repack): YES or rftci\ (circle onel 

{If yes, it's a 100% repack - then product chemistry, acute toxicity and efficacy data 

are not required} 

Data on Group and A and B must be submitted - Group A and B can not be cited. 

Dafa 

Guideline Group A: Product Chemistry Data sUbmitted 

No. Sfudy Tille Yes No 

830.1550 Product Identity & Composition X 

Description of materials used to produce the 

830.1600 product " .' 

830.1650 Description of formulation process 

830.1670 Discussion on the formation of impurities 

830.1700 Preliminary analysis - -

830.1750 Certified limits (158.3451 ~ 

/ 

830.1800 Enforcement analytical method 

Data 

Guideline Group B: Product Chemistry Data submitted 

No. study Tifle Yes No 

830.6302 Color J 

830.6303 Physical State 

830.6304 Odor 

Oxidation/Reduction (Chemical 

830.6314 incompatibility) 

830.6315 Flammability --" 

830.6316 Explodabilitv -.' 

830.6317 StoraQe stability ,~" 

830.6319 Miscibility 

-,,--' 

830.6320 Corrosion Characteristics 

830.6321 Dielectric Breakdown voltage c./ 

830.7000 pH -- 830.7100 Viscosity /' 

-" 

830.7300 Density 

1 

214
R 300 and 301 

New products must provide a bridging rationale document. The bridging document 

directs Opp to use a currently registered set of 6 acute toxicity data and label; instead 

of submitting product specific data. 

Guideline Acute toxicity (6 pack) Cited 

No. Study Title Yes No 

.. 870.1100 Acute OraIILD50) 

870.1200 Acute Dermal (LD50) 

870.1300 Acute Inhalation ILC50) 

870.2400 Acute Eye Irritation .. / 

870.2500 Acute Dermal Irritation ,./ 

870.2600 Dermal Sensitization v" 

Efficacy - which guideline depends on the proposed label use and they must cite the 

data to be used for the br'ldging rationale. 

Guideline Cited 

No. Efficacy Study Titles Yes No Comments 

810.3100 Soil Treatments for Imported Fire Ants 

Livestock, Poultry, Fur and Wool~8earing 

810.3200 Animal Treatments 

Treatments to Control Pests of Humans 

and C// 

810.3300 Pets 

Mosquito. Black Fly. and Biting Midge 

810.3400 (Sand Flv) Treatments 

810.3500 Premises Treatments 

810.3600 Structural Treatments 

Methods for Efficacy Testing of Termite 

810.3800 i Baits i 

2 

, 

215
Print letter 

Enter More Information 

Tracking 

216
FEE FOR SERVICE 

217
INVOICE NUMBER INVOICE SAP DOCUMENT NUMBER 

DATE 

PRIll. FEE-RF2164 11/03/2010 1900130583 

, 

, 

, ""'" 

" , 

" , , 

, 

, , I 

,,"'.,/ Ii 

,; ytJl (~' / 

I , 

U.S. ENVIRONMENTAL PROTECTIONIOO5118 TOTALS ---> 

AGENCY 

m~ifeSciences' 

\ 

"'. Wellmark Inti & Farnam Co's, Inc. 

Central Life Sciences 

1501 E. Woodfield Rd Suite 11200W 

Si:Qaumburg. IL 60173 

1061584 

GROSS AMOUNT DISCOUNT NET AMOUNT 

1,434.00 0.00 1,434.00 

I 

, I , 

I , 

1,434.00 0.00 1,434.00 

Check Number 1061584 70-2328 

.•.• Bank of America 

"\, Bank of America Illinois 

719 

'\ Chicago, Illinois 60697 

\ 

CHECK AMOUNT 

PAY *** ONE THOUSAND FOUR HUNDRED THIRTY-FOUR USD*** 

CHEC~ DATE 

11/04\2010 1,43<i.00

TO THE 

ORDER 

OF 

U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

WASHINGTON FINANCE CENTER 

FIFRA SERVICE FEES 

P.O. BOX 979074 

ST.. LOUIS MO .63197-9000 

\ 

B:OID AFTER):;J- P # 

'\ 

218 *Commercial/financial information may be entitled to confidential treatment*
Wellmark" James McFadden', Ptr.Et 

Wellmark International 

November 19,20 I 0 

Richard Gebken, PM13 

Registration Division, RD 

Document Processing Desk (REGFEE) 

Office of Pesticide Programs (7505P) 

U.S. Environmental Protection Agency 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington V A 22202 

Subject: Submission of New Product Application Containing (S)-Methoprene, 

Ethofenprox and PBO; Product Name: RF2164 Aff COMBO, 2724-XXX 

(Contains Confidential Business Information) 

Dear Mr. Gebken: 

Enclosed with this cover letter please find our application for a new product containing the pesticide 

active ingredients (S)~Methoprene, Ethofenprox and PBO. The new product name is RF2164 AfT 

COMBO, and is a topical (spot-on) treatment for insect pests on dogs packaged with a unique 

applicator device. As discussed with the EPA in a pre~submission meeting on Sep. 15,2010, although 

the formula is identical to our currently registered dog topical with ethofenprox, (EPA Reg. No. 

2724-796, since this new product is packaged with an applicator device, a new EPA registration is 

required. 

Since this new product is identical in composition and use (the use pattern is the same, dire('tion~ for 

use differ only slightly) to our existing product registration (2724-796) we are submitting th;s' .. 

application under PRIA Category R300, with A PRIA fee of S 1434. (Check cOJj't.r,closed.) 

According to the OPP website, the PRIA category R300 is applied to products characterized as:~ 

New product; identical or substantially similar in composition and use to a re,q'istered-p~odtfct; 

no data review or only product chemistry data; cite-all data citation, or sele.::tin data cit,'ltion 

where applicant owns all required data, or applicant submits specific authorization letter from 

data owner. Category also includes 100% re-package of registered end-use or manu,'actunnguse product that requires no data submission nor data matrix. 

Page I of 8 

219
i\<." Product Application, Etofenprox 

Well mark believes that this submission fits all the requirements for PRIA category R300, since: 

The new prodllct is identical in composition and substantially similar in use. 

Because the composition is the same, no data is submitted for review 

We use a selective data citation where Wellmark owns all data 

On this basis, the application components are as follows: 

Form 8570-27, Application for Pesticide Registration 

Proposed Label, 5 copies 

Form 8570-4, Confidential Statement of Formula, (Basic and I alternate, 2 copies) 

Form 8570-27, Formulator's Exemption Statement, I copy 

Form 8570-34 Certification with Respect to Citations of Data 

Form 8570-35 Data Matrix for the RF2164 Arf COMBO 

The following paragraphs provide additional description of: 

I. A list of (previously reviewed) snldies sllpporting this application and 

II. The benefits of the applicator device combined with our ethofenprox-based topical formula 

III. Discussion of the potential exposure issues associated with the applicator device. 

IV. Brief comments on the draft label 

1. Studies Supporting the Application 

The studies supporting this product are exactly those that have been submitted to support the existing 

product, and aU have been previously reviewed by the Agency: 

Product Chemistry: 

47518501 :-lcFadden, T. (2008) Description of Naterials and Formulation f'roces 

s: RF2042 [CDSOj: Filial Report. Projec't Number: 3251. Unpublished 

study prepared by Iyellmark International. 9 p. 

48078:::01 NcFadden, T. (2009) RF2042 (CDSOj-Description of ~'laterials and Form 

ulation Process: Final Report. Project Nurr.ber: 3798. Unpublished 

study prepared by \'Jellmark In'ternational. 10 p. 

47518502 Thornton, K. (2007) Color, Odor, Physical State, Density, Flammabil 

ity and Viscosity of RF2042 tCDSO]: Final Report. Project Number: 

3257, N540. Unpublished study prepared by Hellma!."K Interl1ational. 

25 p 

47679401 KiflS', lAo (2007) Characterization of variou% Samples fOr Etofeliprox 

S-<'lethoprene and PEO for Companion p...nimal Safety Studies - Densit 

y Results: Interim Report. project Number: N540, 3345. Unpublishe 

d study prepared by ;dellmark International. 8 p. 

47518503 ~'titte, J. (2007) Validation of a Chemical J:malysis Procedure fo!:" the 

P'.ssay of the JI.cti1Je Ingredients in R~2042 [CDSOj: Final Report. P 

roject Number: 32~4, N540. Unpublished study p~epared by Hellmark 

lnte~natioilal. 46 p. 

48089001 Johnson, D. (2010) Storage Stability and Package compatibility o~ 2 

042 (CDSO) Topi.cal: Final Report. Project Numbe~: 3276, N54c- Dnp 

ublished study prepared by 'fJellmark International. 22 p. 

Acute Toxicity: 

47518504 Lowe, C. (2008) Acute Oral Toxicity Up and Oo'"m ?rocedur;; in f.2'ts· 

RF2042 (CDSOj. Project Number: 22373, 3271, P320/Um.' iJnpubEshed 

study prepared by Product Safety Laboratories. 17 p. 

n518505 Lowe, C. (2008) }'l.cute Dermal Toxicity Study iE Rats - LiMit Test: R 

F2042 [COSO]. Project Number: 22374, 3272, P;322/RAT. Unpublished 

study prepared by Product Safety Laboratories. l7 p. 

47518506 Lowe, C. (2008) Primary ~ye Irritation Study in Rabbits: RF2042 [CDS 

oj. Project Number: 22375, 3273, P324. unpublished study pr-=l?arEcd 

by Product Safety Laboratories. 18 p. 

Page20f8 

220
, Producl Applicalioll, Elofenprox 

47518507 Lowe, C. (200B; v;;/,-,,"-(.;-~:t $k'-':_0 trritation Study in Rabbits: RF2042 [C 

DSOj. Project: Number: 22JIG, 3274, P326. Unpublished study prepar 

ed by Product Safecy Laboratories. 18 p. 

47518508 Lo'.\'e, C. 

Method) . 

{2008) Dermal Sensicization Study in 

Project Number: 22377, 3275, P328. 

pared by Product Safety Laboratories. 25 p. 

Guinea Pigs 

unpublished 

(Buehler 

study pre 

Acute inhalation toxicity was waived since the product is not sprayed: 

47518:;09 I-lizens, M. (2008) R~2042 [CDSO]: Request for 'tJaiver of p=st.icide Do. 

ta Requiremencs. ~roject Number: 3474. Unpublished stDdy p:cepar'?d 

by vlellma.rk Inter;-:,.ational. 7 p. 

Companion Animal Safety 

47518510 Slone, R. (2008) safety of an Experimental J1''1982 Spot~on F.dminister 

,",=d Topically to Adulc Dogs. <=r:oject Number: PLR~/0750, 3323. Unp,-, 

blished study p:cepzred by Professional Laboratory and Res=arch Serv 

ices, Inc. 661 p. 

47578401 Slone, R. (2002) Safety of on Exp=::-imental 31<1982 Spat~on .t,.dministe!..~ 

ed Topically to Adult Dogs: Final Report Amendment One. Project. Nu 

mber: PLRS/0750. unpublished study prepa:ced by Professional Labora 

tory and Research Servic~s, Inc. 6 p. 

47835301 Slone, R. (2009) safecy of an Experimental JM982 Spot~on Administe-:-:: 

ed Topically to p~P9ies: Amended ?inal Report. Project Number; PLR 

S0751, 3324. unpublished study prepared by Professional Laboratory 

and Research Services, Inc. 49 p. 

47622203 Slone, R. 12008) Safety of an experimental JH982 Spot~on F.dminister 

ed Topically to Puppies. project Number: PLRS/0751, 3324, TN502/15 

1/1. Unpublished study prepared by professional Laboracory and ~es 

4784400l 

earch Services, Inc. 664 p. 

l'1izens, 1'1. (2009) Evaluation of the ToxiCity of Dog 

[cDsol to Cats and iCittens. project Number: 3617. 

dy prepared by Wellmark International. 13 p. 

Spot-orr RF2042 

Dnpt.:blished "cu 

Product Performance Data 

47518511 Everett, W. (2007) 3valuate Ovicidal and Adult Cat Flea Efficacy an 

d Tick E~ficacy of RF2042B on Dogs: Final Report. Project N~~be~: 

3268, 103/004. unpublished study prepared by BerTek, Inc. 20 p. 

47518512 2:verett, N. (2008) Evaluate the Speed of Kill of Rf'~2042B .~gainst T 

icks and Fleas on Dogs: 2inal Report. Project Numbe::-: N540!EFF, 33 

44, 103/006. unpublished study prepa::-ed by BerTek, Inc. 15 p. 

47318513 Everett, N. (2008) C;fficacy of a Combination of Etofenprox aLId :?BC 

(RF2042B) as a Topical Spot~On fo,=, Dogs Experimentally Infected 'flit 

h Adult Ixodes scapular is Ticks and Three Species of Adult Mosquito 

es (Aedes aegypti, Anopheles quadrimaculatus and Culex quinuefascia 

tus). Project Number; N540!E2F, 3362, 103/007. Unpublished study 

prepared by BerTek, Inc. 22 9. 

47578402 3verett, N. (2008) <o:valua.te the Speed of Kill of RF~2042B against T 

icks and Fleas on Dogs: Amended Final Report. Project Number; N540 

/EFF, 3344, 103/006. Unpublished study prepared by BerTek, Inc. l 

6 p. 

47844002 Rudolph, R. [2009) RF2042 (COSO): Summary of. Efiicacy Data. Prcjec 

t NUmber; 3643. Unpublished study prepared by l'lellmark lnternation 

0.1. 9 p. 

Each of these reports is cited in the enclosed Data Matrix form, and each study is owned by Wellmark 

International. 

Page 3 of 8 

221
h ,ProdUCi Application, Etofenprox 

II. Benefits of the Applicator Device Used with Our Ethofenprox Formula 

As discussed in our Sept. 15 Pre~Submission meeting with the EPA, Well mark believes that the 

combination of this unique applicator and our ethofenprox~based dog topical formula offer significant 

benefits to the consumer: 

I. The Applicator Device - the new device provides the consumer with a device intended (and 

confirmed by graphics) only for use on dogs, and which only fits cartridge tubes that are labeled for 

application to dogs. Thus the applicator device will reinforce label language and reduce mis~ 

application to cats, which is a major concern for EPA. 

The Applicator Device also allows consumers to make a one~handed application of the product to their 

pets, resulting in an easier application for the consumer (not needing a third hand to hold the dog while 

they use two hands to apply the product). 

2. The ethofenprox~based fonnula. The relative safety of our ethofenprox formula compared to other 

products has been documented in data submitted to EPA. In this data, it was documented that: 

Compared to a permethrin product, the etholenprox dog topical product has a significantly lower 

total rate of incidents. 

Even considering the lower sales of the ethofenprox product, the number of incidents with cats for 

lhe ethofenprox product is significantly reduced. People who buy the ethofenprox product aren't 

smarter - this product is just much, much safer for cats. 

Finally, the data also shows that the percentage of incidents with small dogs «15 Ibs) is reduced 

compared to a permethrin product. This reduction in incidents for small dogs also represents and 

important benefit for our ethofenprox dog topical. 

Each one of these points addresses a specific issue that was raised by the EPA in their Evaluation of Pet 

Spot~OIl Products. And although the EPA has so far refused to allow us to document these benefits to 

the consumer in any way on the product label, Well mark believes that the data shows this product (dog 

topical and active ingredient) demonstrate significant benefits for the consumer and their pets. 

Therefore, fast~track approval of the registration with the device would benefit both the consumer and 

their pets. 

Wellmark would also like to point out that in our original submission letter for the RF2042 CDSO 

product (now EPA Reg. No. 2724~796), we had noted that: 

....... this new product should also provide reduced risk to applicators and children. 

Ethofenprox has acute mammalian toxicity of category IV and is classified as "not likely" to be 

a human carcinogen I. Since Permethrin has an acute oral toxicity classification in Category III 

and is classified as a likely human carcinogen, an ethofenprox topical product for dogs will 

also provide reduced risk to applicators and children. 

This product is expected to be significantly safer than some of the existing permethrin dog 

topical products, and so it will provide significant benefits to consumers. Although a reduced 

risk classification is not possible since this product does not represent a new use, Well mark 

believes the product does offer significant benefits to consumers: 

• Reduced Risk to non~target animals. Cat deaths from permethrin dog topicals are a 

significant issue at the EPA, and even though the EPA has worked to reduce the potential 

for cat deaths from these products, fatalities still occur. Since testing shows ethofenprox is 

not highly toxic to cats, (and we also sell an ethofenprox spot~on for cats) the dog topical 

product will be much safer than existing permethrin dog topical products. 

I See Federal Register NOlice for EPA's FQPA Rationale for Ethofenprox and subsequent revisions 

Page 4 of 8 

222
1\, Product Application, Etofenprox 

• Reduced Risk to applicators and children. Ethofenprox has acute mammalian toxicity of 

category IV and is classified as "not likely" to be a human carcinogen. Since Pennethrin 

has an acute oral toxicity classification in Category III and is classified as a likely human 

carcinogen, an ethofenprox topical product for dogs will provide reduced risk to applicators 

and children. Note (in this submission) that the RF2042 [CDSO] product was classified in 

Category IV in acute toxicity studies. 

Given the incident data for the existing product that was noted above, we believe these comments made 

in August of 2008 about the safety of this product were right on target. This application for a 

registration with a specific Applicator Device for this formula will extend and increase the benefits of 

this product for the consumer. 

III. Discussion of the potential exposure issues associated with the Applicator Device. 

The application for the RF2164 AT COMBO relies on the existing product chemistry, acute toxicology, 

and efficacy data that support our (existing) related registration, the RF2042 (CDSO), EPA Reg. No. 

2724-796. However, there are specific concerns for human exposure and the exposure to dogs that need 

to be addressed by the EPA in the review of this application. The following paragraphs provide 

Wellmark's position on these issues for consideration by the EPA. (Although HED indicated in our 

meeting that they didn't think the risk was higher than for the existing product.) 

Potential Human Exposure Issues 

Overall, the potential human (adult and child) exposure associated with the RF2164 Applicator Device 

is considered by Wellmark to be similar to (and certainly not greater than) the potential exposure from 

the use of the existing ethofenprox dog topical, EPA Reg. No. 2724-796. 

For applicators, the only relevant route of potential exposure during and after application would be 

dermaL Both ethofenprox and piperonyl butoxide do not have dermal endpoints for systemic effects 

and methoprene is a biopesticide, thus exposure via the dermal route is not of concern. 

The vapor pressure of all of the active ingredients is low, so exposure via the inhalation route is not 

expected. Adults are not expected to have incidental oral exposure from dermal contact with a 

pesticide. 

The design of the RF2164 Applicator Device minimizes dermal exposure during application by: 

• Placement of the applicator cartridge in the RF2164 Applicator Device is done with the 

unopened cartridge, so there is potentially no exposure prior to application. 

• The cartridge is opened by the applicator device, which actually shields the applicator from 

potential exposure. The current product (EPA Reg. No. 2724-796) requires the applicator to 

manually clip open the fluid cartridge with a scissors. Since the manual handling does have 

some potential for dermal exposure, the proposed RF2164 Applicator Device may reduce this 

potential. 

• During treatment of the dog with the RF2164 solution, the RF2164 Applicator Device provides 

some shielding of the applicator's hand (compared to the current device), so potential exposure 

should be reduced2

. In addition, the application itself is changed from a two-handed application 

to a one-hand application, which again could reduce the potential for dermal exposure. 

• After treatment is complete, the disposable cartridge is designed to be securely disposed of in 

trash without additional hand contact, so there is no potential for dermal exposure associated 

with the disposal step. 

• After disposal of the fluid cartridge, the RF2164 Applicator Device is intended (per label 

instructions) to be stored in the plastic clamshell until next use, so the provision of a storage 

container reduces accidental expOSure between applications. 

2 Note that our ethnography studies have shown this is an issue with Frontline® customers. 

Page50fS 

223
l'i ..... Product Application, Etofenprox 

• There could be minimal potential exposure from handling the applicator device during reuse. 

Again, the only relevant route of exposure would be dermal. 

The only expected exposure for a child would be from contact with the pet post-application. Since the 

application rate of the RF2146 product is the same as the cUiTentiy registered product (EPA Reg. No. 

2724-796), both individual and aggregate risk assessments for other spot-on products cover this new 

product. This is also the case for post-application adult exposure and risk. 

Considering these points together, it seems clear that potential human exposure associated with the 

RF2164 Applicator Device is either the same or lower than the potential exposure associated with the 

current product. 

One specific concern that was discussed in the Wellmark's pre-submission meeting with the EPA was 

whether there was any potential for pesticide residue to accumulate on or contaminate the RF2164 

Applicator Device. 

Wellmark suggests that it would be expected that small amounts of the formulation may adhere to the 

outside of the applicator from the application process. However, under normal use these potential 

residues might be relatively constant as the applicator is used to part the hair of the animal and both 

removing and depositing the formulation on the application device. 

Regarding human exposure, the exposure would be dermal and therefore of minimal concern. 

Regarding pet exposure, if the applicator is holding the device over the dog at the time the cartridge 

breaks, the worse case exposure to the dog would be application of a single dose to one spot on the skin. 

If the applicator decides to take another cartridge and treat the animal, the exposure would be 2X the 

intended dose. The companion animal safety study for adult dogs (6 month and older) was done at up 

to 5X the intended dose and no reactions related to the treatment were observed. Therefore, the above 

described scenario would not result in adverse effects in the dog. 

Potential Pet Exposure Issues 

The issues around pet exposure are related to the amount of the actual dose and potential residues 

remaining in the cartridge or on the Applicator Device after application. For example, if pesticide 

residues were transferred to the Applicator Device during application, would those residues be available 

to pets at the next application and could they represent an overdose? 

Well mark's response to these issues suggests that: 

1. Since the efficacy for the RF2l64 treatment is dependent upon duplication of the delivery 

volume for the existing product (EPA Reg. No. 2724-796), it would initially seem important to 

have data verifying that delivery volume for the new product was the same as the existing 

product. 

However, instead of delivery volume being a function of manufacturing that needs 

confirmation, that volume is specifically controlled by manufacturing to deliver the appropriate 

(required) amount. Since Wellmark manufacturing will confirm the cartridge fill volume prior 

to actual production, (and does so for every change in cartridge shape), it is not necessary to 

provide verification of delivery volume prior to sUbmission3

• 

To provide more background on control of delivery volume within a manufacturing 

environment, the following text explains how Well mark controls delivery volume for existing 

packaging. 

) It should be noted that this change in cartridge/tube shape is similar in execution to a number of previous changcs 

in shape or volume that have been executed by Wellmark. In none of these cases did EPA require contirmatory 

data on delivery volume, and so we don't believe it is necessary to provide data for this new product submission. 

Page60f8 

224
l'\~ < ProdUCI Applicalion, Elofenprox 

2. In order to examine potential risks to pets, it is useful to consider the potential likelihood of 

overdosing a dog with dog topicals using the new RF2164 Applicator Device. But based on 

comments already noted above: 

- Since the companion animal safety studies were conducted with a 5X safety margin, small 

variations in the applied dose, even if they were to represent as much as 5% or 10% of the 

application, would not represent a safety hazard to the pets to which a treatment was being 

applied. 

- In addition. the incidence data discussed above for tlte existing product shows it to have an 

excellent record, with a significantly lower rate of incidents and an improved incident profile. 

So on both of these issues (human and pet) related to potential exposure associated with use of the dog 

topical, Well mark believes that: 

- potential exposure to applicators is small and only via a dermal route. Since ethofeprox has no dermal 

endpoint, exposure via the dermal route is not of concern. 

Page 7 of 8 

225 *Manufacturing process information may be entitled to confidential treatment*
l\~ _. Product Application, ElOfcnprox 

- potential exposure to pets would be well within the margin of safety established in companion animal 

safety studies, so pet exposure is not of concern. 

IV. Brief Comments on the label 

A few brief comments on the label are added to aid the reviewer: 

- Text already approved by the EPA (for efficacy claims or precautionary statements) is shown in black 

in the label, added text specific to this product is in color. 

- The efficacy claims flow directly from the existing product (2724-796), but the directions for use are 

necessarily different. 

- Two different (independent) sets of DFU are included - we would like to consider both. 

- As far as we understand, additional label modifications required by Pet Spot On mitigation 

requirements are addressed in the label text. 

V.Summary 

In summary, this cover letter has provided: 

I. A list of (previously reviewed) studies suppolting this application and 

II. A discussion of the benefits of the applicator device combined with our ethofenprox-based topical 

formula, and the demonstrated incident reduction achieved with the existing product 

III. A discussion of the potential exposure issues associated with the applicator device. Background on 

Well mark manufacturing process development was also provided that describes the procedures used to 

define fill and delivery volume. It was also noted that these procedures have been performed each time 

a thermoform shape is changed, and are part of normal production scale-up. (and hence are not 

available prior to registration approval.) 

IV. Brief comments on the label, to provide some additional background information that may be useful 

in evaluation. 

Based on this discussion, Wellmark believes that the consumer bellefit for this product will be 

significant, and we ask the EPA to allow the product to be registered under a Category R300 fast-track 

application. 

If you have questions regarding this submission, or require further information, please let me know by 

e-mail or phone as noted on Page I. 

Regards, 

~~ James McFadden, Ph.D. 

Regulatory Project Manager 

Page 8 of8 

226
Please road instructions on reverse before completing f"'~m Form Approved OMB No 2070-0060 Approval expires 2 -28.95 

,ted States § )stration OPP tdentilier Number 

.... ,-, EPA Environmental Protection Agency Amendment 

Washir1\lton, DC 20460 other 

Application for Pesticide M Section I 

1. CompanylProduct Number 12. EPA Product Manager 

I 

, Proposed Classification 

We))mark InternationaIl2724-)'fX IRR. ' R. Gebken 

-~.~,,---.-----~---~-- ----

4. Company/Product (Name) PM' 

I 

o None o Restricted 

WelJmark InternationallRF2164 AfT COMBO 13 

-- ----._- 5. Name and Mdress of Applicant I Registrant (tnctude ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3) 

WelJmark Intemational (b)(i), my product is similar or identical in composition and labeling to: 

1501 East Woodfield Road, Suite 200W EPA Reg. No 

Schaumburg, ))Iinois 60t73 ------- ---~ ----

Product Name --- o Check if this is a new address 

Section M II 

o Amendment - Explain betow. o Final printed labels in response to 

Agency letter dated o Resubmission in response to Agency letter dated --------------- o "Me Too" Application 

o Notification - Explain below. o Other - Explain betow. 

-

Explanation: Use additional page(s) it necessary. (For section I and section II-I 

Enclosed, please find application materials to support registration of a new pesticide product, formulated as a dog topical application for fleas and ticks. 

This product contains the active ingredients etofenprox, PSO and S-methoprene, and is chemically identical to our existing registration, 2724-796. It is 

submitted as a new product registration because it is packaged with a unique applicator device, but is substantially similar to the existing product. 

Because it is similar in use pattem and chemistry, we ask it be considered under PRIA Code R300. A copy of the check for $1434 that was sent to the 

lockbox is enclosed. For questions, please contact James McFadden, Tel: 847-330-5369; Fax: 847-330-5391; E-mail: jmcfadden@central.com 

Section - III 

1. Material This Product Wilt be Packaged tn: ---- - Child-Resistant Packaging Unit Packaging Water SolUble Packaging 2. Type ot Container 

@Y" @y~ 

X No @Y" X No ~M"" X Plastic 

X No Gtass 

If''Yes Unit No. per If"Yes Unit No. per Paper 

~ Certificaflon musf be Packaging wgt. container I Packaging wgt. container X Other (Specify) cardboard - submitted , 3. Location ot Net contents Information j 4. Size(s) Ret<lil Container 5. location of Labet Directions 

o label o Container t~_I_:~_~_ 9.0 cc tubes, 1 to 48-packs ~onLabel On Label Accompanying Pro~.I:I..~·:' . 

6. Manner in Which Label is Affixed to Product § Lithograph o Other printed on cardboard 

Paper glued 

Stenciled 

Section M IV 

• 

1. Contact Point (Complete Items directly be!~w for Identification of indfvidual to be contacted, if necessary, to process this app:iLo:ix.] 

Name nUe I T elepiuA.J No. (tnctu"~ Area Code) 

James McFadden Sf. Regulatory Project Manager (841) :':;'0-5369 . 

~---

Certification , 

I 6. DatE' AppliC'ltion 

Recei • .;;.; I certify that the statements I have made on this form and all attachments thereto are true, accurate and comptete. I 

acknowledge that any knowingly false or misleading statements my be punishable by fine or imprisonment or both !~I'lmped} under applicable law. 

2.Sign~;~ 3. Title 

Sr. Regulatory Project Manager 

4. Typed Name 5. Date 

James McFadden Nov. 19,2010 

EPA Fonn 8570-1 (Rev. 3-94) Prevtous editions are obsolete. White - EPA File Copy (original) Yellow -Applicant copy 

227
Form approved. OMS No. 2070..0060, 2070-0057. 2070·0107, 2070-0122, 2070-0164. 

&EPA 

United States 

Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Applicant's Name and Address EPA File SymboVRegistration Number 

Wellmark International 2724-XXX 

1501 E. Woodfield Rd., Suite 200W Product Name 

Schaumburg, IL 60193 RF2164 AfT COMBO 

Date of Confidential Statement of Formula (EPA Fonn 8570-4) 

11119/2010 

As an authorized representative of the appticant for registration of the product identified above, I certify that: 

(1) This product contains the following active ingredient(s): 

S-Methoprene 

Etofenprox 

Piperonyl Butoxide 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, 

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by 

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3). 

(3) Indicate by checking (A) or (8) below which paragraph applies: 

'71 (A) An accurate Confidentiat Statement of Fonnula (EPA FORM 8570-4) for the above identified product is attached to this statement. 

That fonnula statement indicates, by company name, registration number, and product name, the source of the active ingredient(s) tisted in 

paragraph (1). 

OR 

., (B) The Confidentiat Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, an 

accurate and contains the infonnation required on the current CSF. 

(4) The following active ingredients in this product qualify for the fonnulator's exemption. 

. , 

Source , 

Active Ingredient Product Name Registration Number 

Etofenprox 

Piperonyl Butoxide 

SignatuL.~ Name and TiUe Date 

James McFadden, Reg, Project Mgrc 11119/2010 

EPA Fonn 8570 . 27 . (Rev. 06 2004) Copy 1 EPA 

Copy 2 -Applicant copy 

228 *Product ingredient source information may be entitled to confidential treatment*
'''" erove ". , F d OMBN 207C . ) 2070..(J057 2070-0W7 2070 Ot22 2070-0t64 

~) UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

-' 1200 Pennsylvania Avenue, N.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration 

and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send 

comments regarding burden estimate or any other aspect of this collection of infonnation, including suggestions for reducing the burden to: Director, CoUection 

Srrn!egies Division (2822T), U.s. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do no! send the completed fonn 

to this address. 

Certification with Respect to Citation of Data 

Appllcant'slRegistranfs Name, Address, and Telephone Number EPA Registration Number/File Symbol 

Wellmark Internationat, 1501 E. Woodfield Rd., Suite 200W 2724-XXX 

Active Inqredient(s) and/or represenlative test compound(s) Date 

S-Methoprene, PSO, Etofenprox November t9, 20 to 

General Use Pattern(s) (list all those claimed for this proc:luct usin(:l 40 CFR Part 158) Product Name 

Pets and domestic animals (dogs) RF2164 /iff COMBO 

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to 

submit this form. You must submit the Formutator's Exemption Statement (EPA Form 8570-27). 

0 I am responding to a Data-Call-tn Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should 

be used for this purpose). 

SECTION t: METHOD OF DATA SUPPORT (Check one method only) 

0 I am using the cite-all method of support, and have included with this form [2] I am using the selective method of support (or cile-all option. 

a list of companies sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a 

should be used for this purpose). completed list of data requirements (the Data Malrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

!Required if using the cite-all method or when using the cite-alt option under the selective method to satisfy one or more data requirements! 

0 I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, 10 the extent required by FIFRA. 

SECTION III: CERTIRCATION 

I certify that this application for registration, this form for reregislration, or this Oala-Call-In response is supported by all data submitted or cited in the 

application for registration. the form for reregistration, or the Oala-Call-In response. In addition, if the cite-all option or cite-all option under the selective method is 

indicated in Section I, this application is supported IYf all data in the Agency's files that (1) concern the properties or effects of this product or an identical or 

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the dala 

requirements in effect on the date of approval of this application if the application sought the initial registralion of a product of identical or similar composition and 

uses. 

I certify that for each exdusive use study cited in support of this registration or rereg'lslration, that t am the original data submitter or that t have obtained 

the written permission of the original data submitter to cite that study. 

I certify that for each study c~ed in support of this registration or reregistration that is not an exclusive use study, either: (a) t am the original data 

submitter; (b) t have obtained the permission of the original data submilter to use the studt in support of this application; (c) all periods of eligibility for 

compensation have expired forthe study; (d) the study is in the public merature; or (e) I have notified in writing the company that submitted the studt and have 

offered (I) to pay compensation to the extent required by sections 3(c)( t)(F) and/or 3(c)(2)(8) of FIFRA; and (ii) to commence negotiations to determine the 

amount and terms of compensation. if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in 

accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such 

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with 

FIFRA. 

I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishabte by fine or imprisonment or both under applicabte law. 

s~natu~~ Date Typed or Printed Name and Title 

Nov. t9,2010 JamesMcFadden, Sr. Regulatory Project Manager 

EPA Form 8570-34 (12 . 2003) ElectrOniC and Paper versions avarlable. Submit only Paper version . 

229
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Form Approved OMS Nos. 2070-0060; 2070-0057; 

1200 Pennsylvania Avenue, N.W, 2070-0107; 2070-0122; 2070-0164 

WASHINGTON,D C 20460 

Paperwork Reduction ACINolica: The public reporting burden for lhis collection of inforrnaUon is eslimated 10 average 0.25 hours per response for regislralion activilies and 0.25 hours per response for reregislration and special review activities, including lime for reading lhe inslru~li~ns1~~. compleling lhe necessary forms. Send commenls regarding lhe burden estimate or any olher aspect of lhis collection of informalion, inciuding suggestions for reducing lhe burden 10: Olreclor, Collection Slrate les DiviSion 2822 U.S, Environmenlal Proleclion A en ,1200 Penns Ivania Avenue, N.W. washin Ion DC 20460. Do nol send lhe form 10 lhis address. 

DATA MATRIX 

Date: November 19, 2010 EPA Re No.lFile S mbol 2724-XXX Pae1of1 

AppUcant's/Registrant's Name & Address Wellmark lntemationaJ Product 

1501 E. Woodfield Rd., Suite 200 West RF2164 NT COMBO 

Schaumburg,lL 60173 

In redlents: S -Metho rene, Etofen rox, PSO 

Guideline Reference Number Guideline Stud Name MRID Number Submitter Status Note 

830.1600 ~ 830.1750 Description of Materials and Formulation 47518501, Wellmark International OWN 

Process 48078201 

830.6302 - 830.7300 Product Chemistry - Physical and Chemical 47518502, Wellmark International OWN 

Properties 47679401 

830.1800 Enforcement Analytical Method 47518503 Wellmark International OWN 

830.6317,830.6320 Storage Stability, Corrosion Characteristics 48089001 Wellmark International OWN 

870.1100 Acute Oral Toxicity 47518504 Wellmark International OWN 

870.1200 Acute Dermal ToxiSity 47518505 Wellmark International OWN 

870.2400 Acute Eye Irritation 47518506 Wellmark International OWN 

870.2500 Acute Dermal Irritation 47518507 Wellmark International OWN 

870.2600 Dermal Sensitization 47518508 Wellmark International OWN 

870.11 00~2600 Acute Toxicity - Waiver Request 47518509 Wellmark International OWN 

810.3300 Efficacy· Fleas and Ticks 47518511 Wellmark International OWN 

810.3300 Efficacy· Fleas and Ticks 47518512 Wellmark International OWN 

810.3300 Efficacy - Ticks and Mosquitoes 47518513 WelImark International OWN 

8103300 Efficacy Fleas and Ticks 47578402 Wellmark International OWN 

810.3300 Efficacy - Fleas and Ticks 47844002 WelImark International OWN 

870.7200 Target Animal Safety Adult Dogs 47518510 Wellmark International OWN 

870.7200 Target Animal Safety Adult Doos 47578401 Wellmark International OWN 

870.7200 Target Animal Safety - Puppies 47835301 Wellmark International OWN 

870.7200 Target Animal Safety ~ Puppies 47622203 Wellmark International OWN 

870.7200 Target Animal Safety ~ General 47844001 Wellmark International OWN 

Signature ~-~ Name and Title Date 

~ James McFadden, Sr, Regulatory Project Manager November 19, 2010 < 

--, EPA Fonr1S570-35 (12-2003) Eleclronlc and Paper versionS available, Submilonly paper version. 

230
Fo~m Approv,eci OMB ,Nos. 2070-0060; 207G-Q057; 

207Q.0107; 20?()..Ot22; 2070-0164 

Manager 

231
UNITED STATES ENVIRONMENTAL PROTECTION 

1200 Pennsvivanla Avenue, N,W. 

,,,20OW 

-reverse 

10425, 

I~Ui. 10679. 

10681.10683. 

10684. 10867. 

Hl879, 11491. 

158709, 158715 

5007755. 

Form Approved OMB Nos. 2070-0060; 2070-0057; 

2070-0107: 2070-0t22; 2070-0164 

232
UNITED STATES ENVIRONMENTAL 

1200 ~.~~~~~!~!l~a.!-~e!l~' 

2_ 

42831303, 

International 

Form Approved OMB Nos. 2070·0060; 2070.0057; 

2070-0107; 2070-0122; 2070.0164 

Manager 

233
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UNITED STATES ENVIRONMENTAL PROTECTION 

12729,10417, 

10433,10434, 

10435, 10436, 

10437,10438, 

11484,11485 

10876, 10875, 

10422,158704, 

N.w. Form Approved OMB Nos. 2070·0060; 2070-0057; 

2070·0107; 2070·0122; 2070·0164 

'-".-~------"----~'.--,.- .--.~~ -----,. '---

234
EPA Form 8570-4 tRev. 9-94) 

IQe.r~ 'ifF roved. -eor 1\01\- -liDO!, V$e., l<C.- %0 WMe 

- EPA File Copy (original) Yellow - Applicant CQp)' 

235

*Confidential Statement of Formula may be entitled to confidential treatment*
EPA Form 8570-4 tRev. 8-941 

Ine.d> ~fPro"",J ~~<" non-~~o.l. Ll~e.. .. t< .. c.. 'y& 

WhUe - EPA File Copy tOriginal) Yellow 

- Applicant copy 

236

*Confidential Statement of Formula may be entitled to confidential treatment*
237

*Confidential Statement of Formula may be entitled to confidential treatment*