# REGISTRATION 2724-811

## DATA PACKAGE BEAN SHEET Date:**20..Jul~2011** Page 1of3 

## *** 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 Sentfor Review 

## * * *
Printed on Page 2 

## * * *Additional Data Package forthis Decision 

## * * *
NoAdditional Data Packages 

## * * * Data Package Instructions 

## * * * Byronb, Please find attached a label amendementfor addtion of puppies to the label. 2724-796 and 2724-811 are relyiong on the same data. Kevin 305-5063Page 2 OP#: (392062)**~** ** Studies Sentfor Review * ** Oecision#: (450780)

# ~~Page 3 DP#: (392062) ** * Product
... A Data Package Ingredients ** * Decision#: (450780)

/067501

### ~1'{)3-6 IPiperonyl butoxide(5%) 1128965

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

### - 

# ISB'S Front-end PRlA 

# Completeness Screen Draft 3; 10/25107



### - 

### 'ecipl Date:

# NOV 23Z010 EPA Reg. Number: 

# ,J,7J.if

- IRi2,
Check List Item -"

- -- -



### - 

### II I' 

### as the PRIA Fcc been Paid; is acopy ofthe check or



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

..

### - 

### 'all APllliciltiOIl Form (EPA**FOln18570~I)** 

### Included 

### in the Is**:~** 

# s II

### uhmiss'ioll Package, is 

### it completely filled 

### out and signed

lcludingpackage type?



### -_._._- Is

### 'a ConHdcutial StatementofFormula (EPA Fom1**8570~** 

### 3 2

### 9) Included in the Submission Package, is it completely

,I

(,


### 7 

### Iilied 

### Dut and signed (boxes**1~21)? .-.~-**  

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

### 7) Included in the Submission Package? Is 2

--...

# _--_.-

,11 C'crtiricntioll 

### with**I~cspcct** 

### to 

### Citation of

### Data (EPA Is I 

### orn] i)S70<M) 

### Included in the SubmissionPackage?

------_.-"_.-

· H 

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

### Suhmlsslon 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 

# Xl)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 

### SeniorRegistrations Specialist Wellmark International 1501 East Woodfield Road, Suite 200 West Schaumburg, IL 60173 Subject: Label Amendment (R300) 

### RF2164-AlTCombo EPAReg. No. 2724-811 

### Submission dated August 25, 2011 Dear Ms. Ruebl, 

## OCT

- 

## 6 1011

The amendment referred to above, submitted in connection with registration underthe Federal Insecticide, Fungicide and Rodenticide Act, is acceptable. A stamped copy ofyour 

### label is enclosed for your record. Ifyou

### 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

# RF2164

# AfTCOMBO [Textfor"Dog" must besamesize as Brand Name] Front Pane!**~** For Use Onlyon 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 ofage orolder [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 monthlytreatments) [1J[3J[4][6J Months Supply [24J[48J doses Spreads naturallywith 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] 

### [Fresh J(Glean

### JJJScentJ(SmellJ [Reapply monthly] [Suitable for year-round use][Month] sticker for home calendar [Satisfaction guaranteed oryour 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 ofTicksfor up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hours][Kilis more than 5Q% offleas 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 maytransmit Lyme Disease Kills and Repels mosquitoes (the major carrier ofcanine heartworm) Monthly application for most effective protection IGRClaims: [Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea developmentfor [more than 10weeks] up to [75 days][2.5 months]] [Breaks Flea Life Cycle for [more than 10weeks] up to [75 days]{2.5 months] [Controls flea reinfestation for [more than 10 weeks] upto {75 days]{2.5 months] [With {S-Methoprene] Insect Growth RegUlator [IGR] to Break Flea Life Cycle]



# ACCEPTED OCT

- 

## 6 " UndertheFederallnsect1cl:de, FungIcide, and RodenUctdeAct, asamended, fOI" thepe&tlctde Registered under EPARe;<. No.

.. 

# 'l:II

1Applicator 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] getdown to [the][your][dog's] skin Ergonomically contoured [ergonomic][shape][design] for easy handling [ease of use] [easy use] For usewith [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 automaticallyopens 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
- notyour hands Directs the liquid onto your dog
- notyour hands Directs the liquid onto your dog
- awayfrom your hands Applies liquid to your dog's skin
- notyours Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet Convenient, easy to useACCU-TIP [Applicator]]DISPENSER] [Easy to use] Longer applicator tip for easyapplication 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 notto drip when set on top ofthe counter, or table, or other flat surface. For usewith [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] monthlytreatments) [1][3][4][6] Months Supply [24][48] doses Easyto 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

### Thermoform name options (tube. cartridge andvial 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]



### 3SUBLABEL 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 OTHERANIMALS! [Back Panel] DO NOT USE ON CATS 

### Keep cats awayfrom treated dogs for 24 hours. Ifapplied or ingested, contact your veterinarian immediately. [RF2164

### AfT COMBO] prevents flea eggs from developing into adultfleas [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 foryour 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'tjust 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 applicatorforyou. 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] foryourdog 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 otherflat 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 directlyto dog without using the applicatordevice, 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 COMBOworks by application directly to the dog's skin, not to the hair. When applying, use applicator device tip to push aside dog's hairto 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

### [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 hasthe same 6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, sothe minor differences relate to devicefeatures. Potential icon designs are on the last pages ofthis 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 applythe [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 ofthe back from the shoulderto the base ofthe tail. At each spot, use the tip ofthe applicatordevice to partthe hair until the skin is visible. Then push down on the round [circle][butlon][thumb pad] to dispense a portion ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some of the solution to run offthe 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 overthe 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 oroffer for recycling if available. [Close applicator device door and store [applicator device] in original package.] 6. USE RESTRICTIONS: Do not reapply product for30 days unless re-treatment is required, but not soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]



### 5FOR [LARGE][EXTRA LARGE] DOGS 

### 1 

### 2 3 4 The dog should be standing foreasy application. Apply RF2164 AIT COMBO evenly to four orfive spots on the top ofthe back from the shoulderto the base ofthe tail. At each spot, use the tip ofthe 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 ofthe 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 offthe side ofthe dog. Do not spread RF2164

### NT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours aftertreatment 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] doorfacing 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 ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164AIT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatmentwill help to distribute the material over the skin. 5. DISPOSE [icon] Push side [buttons] to open doorand drop emptytube [vial][cartridge] into tra'iS, 0:-<Jfferfor recycling if available. [Close applicatordevice doorand 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

### 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 hairand get next to dog's skin. [Press circle on [color] door][Press round thumb pad] once at each offour orfive [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 aftertreatment 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]underthe [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] doorand the tube will snap open. 4. APPLY [icon] 

### The dog should be standing for easy application. To apply, use tip to part hairand get next to dog's skin. Press [circle] [[round] thumb pad] on [color] dooronce 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 ofthe solution to run off the side of the dog. Do not spread RF2164 AfT COMBO by hand overthe dog. Although the dog's 

### skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] 

### To dispose ofempty tube, open [color, e.g. green] door and drop empty tube into trash or offerfor recycling ifavailable. [Close applicator device doorand 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 8days' afterthe initial treatment. Do not retreat more than once per month. ' [Note: Each package contains sufficient cartridges/tubes/vials for [X] application::;J



### 7FOR [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] dooronce at each offourorfive 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 offleas. [The successive feeding activity offleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment of dogswith 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 awayfrom children and animals. Liquid Cartridge [vial][tube] Disposal: Ifempty: Do not reuse cartridge [vial] [tube]. Place in trash orofferfor recycling if available. If partiallyfilled: CalJ your local solid waste agency for disposal instructions. Never place unused productdown any indooror 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 orclothing. 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 1nay 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 ofwater. If signs continue, consult a veterinarian immediatb[VSome pets may experience hair loss ortemporary 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. 

### 8FIRSTAID 

### Ifin eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, 

### if present, afterfirst 5 minutes, then continue rinsing 

# • Call a poison control center ordoctorfortreatment 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: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistentwith applicable law, Seller makes no otherwarranties, and disclaims all other warranties, express or implied, including but not limited to warranties ofmerchantability and fitness for the intended purpose. To the extent consistentwith applicable law, seller's liability for default, breach, or failure under this label shall be limited to the amount ofthe purchase price. To the extent consistentwith applicable law, Sellershall have no liabilityfor consequential damages. In case ofemergency orfor product information, call 1-800-xxx-xxxxor contact your veterinarian ifyour 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 Onlyon Toy (6-12Ibs.), Small (13-31 Ibs.), Medium**(32~55Ibs.),** Large (56 -80 Ibs.), and Extra Large (81 Ibs. and over) Dogs 6 months ofage orolder



### 9

### Alternate Sets of ICONS for the RF2164 AIT 

### COMBO [ICON SET 1] [OPEN] [LOAD]

# ~**~** [CLOSE]

[APPLY]

[DISPOSE]



### 10[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' UPmID aPl',icalDr

Clicktube llf1d€<



### Closethe green dOC<and



### the tubewill

### snapopen. To APPLY Use

### Tip ID

### partfur and 

### get next

### todog'sskirL



### . Pfe'"'...scircle ongreen door 

### once ateachof**~** 

### spo-s bet'Neen shoulders andtail

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 LOADplace tubeWHITE00eUP**~erthe**gre-:ntabs

CLOSEthe green door and thetube will snapopen. 

### 11

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


### Use l!!1ger

### scoop

### to HIt OPEN

### door

ToAPPLY UseTlPbpartrur and

### get

### nextrodog's skill

'.**C"=~ circ~** 

### on

### greendoor 

### onceatead1of#1 

### spots betweenshoulders andtall



### ("#Spots" is a variable dependent on size) Door color may change based on brand.



### 12[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 soonerthan 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 tearofffirst applicator [tube]. [ 2. Hold applicator [tube][and bend area of plastic at perforation, tear offand discard.] Hold applicator [tube] upright and snap tip back, away from face and body. 3. The dog should be slanding foreasy applicalion. Apply RF2164AIT COMBO evenly 10 [two spots](loy dogs)[lhree spols](small ormedium 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 ofthe dog. 4. Do nol spread RF2164 AlT COMBO by hand over Ihe dog. Allhough Ihe dog's skin and hairoils 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 soonerthan 8 days afterthe 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 tearofffirst applicator [tube]. 2. Hold applicator [tube][and bend area of plastic at perforation, tear offand discard.] Hold applicator [tube] upright and snap tip back, away from face and body 3. The dog should be slanding foreasy applicalion. Apply RF2164 AIT COMBO evenlyto fouror five spots on the top of the back from the shoulderto 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 ofthe solution at anyone spot that could cause some of the solution to run off the side of the dog. 4. Do nol spread RF2164AlT COMBO by hand over Ihe dog. Allhough Ihe dog's skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours afterapplication will help to distribute the material overthe 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 afterthe 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 -.Jfthes-3 pests in conjunction with this treatment. Monthly treatments are required for optilrlal controi and prevention offleas.



### 13

### (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 ofthis 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

### SUB-LABEL B FOR REFILLPACKAGE (For use with applicatordevice 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(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 awayfrom treated dogs for 24 hours. Ifapplied 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'tjust 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 applythe RF2164 AfT COMBO treatmentwith 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] applicatordevice.] Ifyou need directions for application, please call1-800-XXX-XXXX. [However, ifyou choose to apply directlyto 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 afterthe 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 hairto allow direct application to the skin. Do not get this product in dog's eyes or mouth.



### 16

### [(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 tearofffirst applicator [tube]. [ 2. Hold applicator [tube][and bend area of plastic at perforation, tearoff and discard.] Hold applicator [tube] upright and snap tip back, awayfrom 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 ofthe back from the shoulderto the base of the tail. At each spot, part the hair until the skin is visible. Place the tip ofthe tube on the skin and gently squeeze to expel a portion ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe 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 overthe entire dog, brushing the dog 12-24 hours afterapplication 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 soonerthan 8 days afterthe 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 orfive spots on the top ofthe back from the shoulder to the base ofthe tail. At each spot, part the hair until the skin is visible. Place the tip ofthe tube on the skin and gently squeeze to expel a portion of the solution on the skin. Do not apply an excessive amount ofthe solution at anyone spotthat could cause some ofthe 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 hairoils will naturallydistribute the application overthe entire dog, brushing the dog 12-24 hours after application will help to distribute the material overthe skin

.. 5. Discard empty [tube][applicator] as described in Storage and Disposal 6. Do not reapply productfor30 days unless re-treatment is required, but not sooner than 8 days afterthe 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. Monthlytreatments are required for optimal control and prevention offleas. [The successive feeding activity offleas 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 ofthis condition.] [RF2164 

### AfT COMBO is water resistant and remains efficacious following exposure to rainfall orswimming.]



### 17[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 NTCOMBO from: NDTES:.-,-,--cc_---,-
___ , Treatment table can be expanded based on package size. {6 months}]] 

### (Precautionary/FirstAid and Storage/Disposal) text included} WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistentwith applicable law, Seller makes no otherwarranties, 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 ofthe purchase price. To the extent consistentwith applicable law, Sellershall have no liabilityforconsequential damages. In case ofemergency or for product information, call1-800-xxx-xxxx or contact your veterinarian ifyour pet is experiencing an adverse event.

WeUmark International 1501 East Woodfield Road 200W Schaumburg, Illinois 60173



### 18

# Wellmark

August 25, 2011 Wellmcuk Intei .onell 1501 Eosl Woodfield Rood, SUIIe 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 WITHOUTAPPLICATOR DEVICE USE FOR RF2164 NT COMBO/EPA REG. NO. 2724-811 Dear Mr. Gebken: Enclosed is a completed EPA Form**8570~**1and 5 copies ofamended 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 ifthey 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 ofthis label. Ifyou 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

# " ease raad/ tmcti 

## "' ons onreverse

# ", , recompf ti**~** e ng orm F oem A**pproy~** o. 

## . ... OMS N 2070 0060 Approva 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/RF2164AIT Combo 13

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

Wellmark Inlernalional (b)(i), my producl is similaror idenlicalin composilion and labeling 10: 1501 East Woodfield Road, Suile 200W EPA Reg. No Schaumburg, Illinois 60173 Producl Name 

# n Checkifthisis enew address Section· II 

# G Amendment
- Explain below. 

# o Final printed labels in response to Agency letterdated 

# D Resubmission in response to Agency letterdated

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

# o "Me Too" Application 

# o Notification

- Explain below. 

# o Other

- Explain below.

...

### --

... Explanalion: U$e additioll8t page(s) it neces5a'Y. (For$OC\ion tand 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 ProductWill be Packaged In:



### -- Child·Resistant Packaging Unit Packaging Water SOluble Packaging 2. Type ot Container 

# t]y" @y",**~M''''** 

# @y", X No X Plastic No 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 otNet 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'?'!** __ofIndIYfdua/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 Icertify 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) underapplicable 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 Fonn8570-1 (Rev. 3-141 Prevtou. ocIItloraareoInoIete. . White EPA File Copy (ongmal)


### - Yellow Applicant copy

## [leT
- 6

OCT - 5 2C11 Tracking Create Resubmission FFS letters

Action Cede Hl!Jlory SecondaryDecision



## OCT

- 

## 6
V lJO

## FASY-

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

### Experts In-Processing**Signa~re:**


### EPA

### Reg: Number:

# 't 

# z1

1 

### ApplicationForm 

### (EPAFonn8570-1)

### -signed?

2 

### StatementofFormula(EPA

### Fonn 

# ..**1i)~1** 

### J 

# Screening**Ch~cklist** 

# .

3 Cel"tifica1ion

### withRespectto Citation

### ofData(EPA Fonn 8570-34) signed?



### 4**Formrilator~s** 

### Stateinent(EPA

### Form8570·27)

-

owns onlythe

6 IsLabelIncJuded? (5copies)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### JAMES MCFADDEN, PH.D. WELLMARKINTERNATIONAL August 31, 2011

1501 E. WOODFIELD ROAD, SUITE 200 WEST SCHAUMBURG, IL 60173

PRODUCTNAME: RF2164

### AJTCOMBO COMPANYNAME: WELLMARKINTERNATIONAL OPP IDENTIFICATIONNUMBER: EPAFILE SYMBOL: 2724-811 EPA RECEIPTDATE: 

### 08/30111
SUBJECT: RECEIPT OF AMENDMENT
DEARREGISTRANT: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### The Office ofPesticide

### Programs has received your application for an amendment and 

### it has passed an administrative screen for completeness. 

### During the initial screenwe determined that the application appears to qualifY for fast track review. The package will nowbe forwarded to the Product Manager for reviewto 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, 

# tt1hrpu.- 

### Front End Processing Staff Information Services Branch Information Technology & 

### Resources Management Division

# 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 subjectto FFS action.**~'f'-/** 

# 1------:t\ctran-CO-de-: 1 • 

# ParentiChildDeciSions:l. 

# II Requested: Granted: Amount Due: 

# $

__ _ !
----______ 1 '---------

----------**-~** 

### D 

## Uncleared Inert in Product Reviewer:__

# +iv4-t~\,-A----\-7'~'__\_')-'------ Date: 

# il4/1

Remarks: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 Subiabel A - use with applicator device Directions for Use: added optional text to coverdirect application reference 6-8 Directions for Use: added generic "color" to door/tabs descriptoras 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 forapplication directly on dog without using applicatordevice (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 orwithout 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 Usefordirect application to dog

(directions for use are same as DFU already approved for2724-796)



### 1

## r,.r'2164 AfT 

## COM80 (Textfor "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 Onlyon Dogs 6 months ofage orolder (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] monthlytreatments) (113](4](6] Months Supply (24](48] doses Spreads naturallywith 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] [Fresh1Clean]((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 3weeks] and (kills and repels mosquitoes for 3 to 4 weeks] ]protects for up to (Four/4] Weeks](One month]]Four/4Week [Flea][fick][Mosquito] Treatment] [Aids in Control ofTicks for up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] (Kills 85% ofticks within 48 hours][Kills more than 50% offleas 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 developmentfor [more than 10weeks] 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]



### 1Applicator Claims [New] [applicator] [New] contemporary design [brand name] [Applicator] helps to prevent getting liquid on [your] hands [brand name] [Applicator] tip parts hairto 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
- notyour hands Directs the liquid onto your dog
- away from your hands Applies liquid to your dog's skin
- notyours Helps prevent applying the wrong spot-on (dose] [product] on [to] the wrong pet Convenient, easy to useACCU-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 Onefree month supply (dose] included Bonus pack Free (applicator](tube](vial[cartridgeO(inside] Designed not to drip when set on top ofthe counter, ortable, or otherflat surface. For usewith [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



### 2Thermoform 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

### SUBLABELA - APPLICA. ,R DEVICE PACKAGE 1. DIRECTIONS FOR USEWITH 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 awayfrom treated dogs for 24 hours. Ifapplied 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 foryour 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'tjust kill adult fleas and ticks, it also prevents reinfestation by knocking out flea eggs and larvae that CQuid hatch lateron. 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 yourdog 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, counteror other flat surface, itwon't run outor 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. [Ifyou choose to apply directly to dog without using the applicator device, read and follow the Directions for Use For DirectApplication 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 afterthe initial treatment. Do not retreat more than once per month. RF2164

### AlT COMBOworks by application directly to the dog's skin, not to the hair. When applying, use applicatordevice tip to push aside dog's hair to allow direct application to the skin. Do notget 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 applicatordevice that allows dog OW'flPrS to tre?t their dogs more securely, and dispose of liquid cartridges [tubesj[vials]with less '11ess.



### 4

### [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 allowforflexibility in device manufacturing. Each set of DFU has the same 6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minordifferences relate to device features. Potential icon designs are on the last pages ofthis document. Text appearing on icon pages is for illustrative purposes only and does not represent full text as indicated in DFU which will appearon labeL] [DFU Set No.1] FOR [TOy][SMALL][MEDIUM] SIZE DOGS To applythe [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 applicatordevice 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 ofthe back from the shoulder to the base ofthe tail. At each spot, use the tip ofthe 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 ofthe solution on the skin. Do not apply an excessive amount of the solution at anyone spot that could cause some ofthe solution to run offthe side ofthe 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 overthe 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 applicatordevice over trash. Push side ]buttons together] to open applicator device door and discard empty cartridge [tube][vial] into trash or offerfor recycling if available. [Close applicator device doorand 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]



### 5FOR [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 orfive spots on the top of the back from the shoulderto 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 overthe dog. Although the dog's skin and hairoils 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 [foreach application] with the applicatordevice. 1. OPEN [iconJ With green [color] doorfacing downward, push side [buttons] to open applicator. 2. LOAD [iconJ (3 alternate statements) -[To Load, insert tube [cartridge][vial] [colorside 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 thatcould 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 treatmentwill 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 applicatordevice doorand 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~** afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X]**applicati('lr'~]** 

### 6FOR [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 offour 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 applicatordevice. 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 hairand 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 offerfor recycling if available. [Close applicator device door and store in original package.] 6. USE RESTRICTIONS Do not reapply product for30 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]

7FOR [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 offour 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 offthe side of the dog. Do not spread RF2164 

### AfT COMBO by hand over the dog. Although the dog's skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment 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 foroptimal control and prevention offleas. [The successive feeding activity offleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs 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: Ifempty: Do not reuse cartridge [vial] [tube]. Place in trash oroffer for recycling if available. If partiallyfilled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoordrain. 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 thoroughlywith 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. Ifsigns of sensitivity occur, bathe your pet wich mild soap and rinse with large amounts ofwater. 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

### FIRSTAID 

### If in eyes 

# • Hold eye open and rinse slowly and gentlywith water for**15~20** minutes. 

# • Remove contact lenses, 

### if present, after first 5 minutes, then continue rinsing 

# • Call a poison control center ordoctor fortreatment 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 otherwarranties, 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 ofage orolder



### 9

### Alternate Sets of ICONS for the 

### RF2164 

### NT COMBO [ICON SET 1] [OPEN] [LOAD] 

# " "


### [CLOSE]

[APPLY]

[DISPOSE]



### 10

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

To 

### LOAD Placetulle

### witt1 WHfTEskle



### To APi>LYUseTip

### to parlJur and

### gel

### nextto dog's**skin~** Presscircle00

### green doc<



### once at

### eachOf # 

### spots**t:e~.veen**Shoulders 

### andlal**~SPOSE**of

### emptytube toosklebu1!oos

### to dOcrand



### ("#Spots" is a variable dependent on size) Door color may change based on brand. 

### (Allernale LOAD icon)
TolOADplacetube"h'HITEskie UP**~rthegr~ntats**

CLOSEthegreen door andthetubewi!'! snap

### open.. 

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

### fingerscoop

### to ittOPEN

### door



### To LOAD

### placetube 

### WHITE side UP**~rthe** 

### greentabs

CLOSE

### tI1e

### green door and the tube wilsnapopen. 

### To APPLY

### UseTip

### to partfur and

### getnext

### to dOg's 

### skin.



### .PresSc:irCl€ ongreendoor 

### onceateachof' spots betweenshoulders and

### tail



### tube



# :

(U#Spots" is a variable dependent on size) Door color may change based on brand.



### 12[2. DIRECTIONS FOR USE, 

### _R DIRECTAPPLICATION TO DOG USE RESTRICTIONS: Apply this productonce every 30 days unless a retreatment is necessary. 00 not make the retreatment soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. RF2164 NTCOMBO works byappfication directlyto the dog's skin, notto the hair. When applying, manually push aside dog's hairto allowdirect application to the skin. Do not get this product in dog's eyes or mouth. [(Note: Application nowassumes one applicator peranimal per application)J [Note: Each package contains sufficient tubes/applicators for

### [Xl applications] FOR [TOy)[SMALl][MEDIUM) SIZE DOGS 1. Bend at perforation and tearofffirst applicator [tube]. [ 2. Hold applicator [tube][and bend area of plastic at perforation, tear offand discard.] Hold applicator [tube} upright and snap tip back, awayfrom face and body. 3. The dog should be standing for easy application. Apply RF2164

### Aff COMBO evenlyto [two spots](toy dogs)[three spots](small or medium dogs) on the top ofthe back from the shoulderto the base ofthe tail. At each spot, part the hair untilthe skin is visible. Place the tip ofthe tube on the skin and gently squeeze to expel a portion ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run off the side ofthe dog. 4. Do not spread RF2164

### Aff COMBO by hand overthe dog. Although the dog·s skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours afterapplication will help to distribute the material overthe 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 afterthe 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 tearofffirst applicator [tube]. 2. Hold applicator [tubeJ[and bend area of plastic at perforation, tearoffand discard.J Hold applicator [tube} upright and snap tip back, awayfrom face and body 3. The dog should be standing for easyapplication. Apply RF2164

### Aff COMBO evenlyto fourorfive spots on the top ofthe back from the shoulderto the base ofthe tail. At each spot, part the hair until the skin isvisible. Place the tip ofthe tube on the skin and gently squeeze to expel a portion ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. 4. Do not spread RF2164 

### Aff COMBO by hand over the dog. Although the dog's skin and hairoils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours after application

### will help to distribute the material overthe 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 soonerthan 8 days after the initial treatment. Do not retreat more than once per month. RF2164

### AfT COMBO is most effective when used as part ofa 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 offleas.



### 13

### [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 ofthis 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

### SUB·LABEL B FOR REF!LLPACKAGE CARTRIDGES 

### (For use with applicator device ordirect-application to dogwithoutapplicator 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)! 0.15fI 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(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 awayfrom treated dogs for24 hours. Ifapplied or ingested. contactyour veterinarian immediately. [RF2164

### AfT COMBO] prevents flea eggs from developing into adultfleas [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 foryourdog. [brand} provides flea and tick protection fordogs for up to 3D-days
- and protection from flea reinfestation beyond. That's because it doesn'tjust kill adult fleas and ticks, it also prevents reinfestation 

### by knocking out flea eggs and larvae that CQuid hatch lateron. 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 applicatordevice.] [Remove one refill tube [cartridgeJ[vial] from the package and insert into opened [brand name] applicatordevice. Make application according to label directions supplied with the [brand name] applicator device.] Ifyou need directions for application, please call 1-800-XXX-XXXX. [However, if you choose to apply directly to dog without using the applicatordevice, read and follow the Directions for Use For DirectApplication to Dog on this package.] (DIRECTIONS FOR USE FOR DIRECTAPPLICATION 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 afterthe initial treatment. Do not retreat more than once per month. RF2164

### Aff COMBOworks by application directly to the dog's skin, not to the hair. When applying, manually push aside dog's hairto allowdirect application to the skin. Do not getthis product in dog's eyes or mouth.



### 16[(Note: Application now assur., .,j one applicator peranimal per applicc.. 

### (1)] [Note: Each package contains sufficienttubes/applicators for [X] applications] FOR [TOy][SMALL][MEDlUM] SIZE DOGS 

### 1. Bend at perforation and tearofffirst applicator [tube]. [ 2. Hold applicator [tube][and bend area of plastic at perforation, tearoffand discard.] Hold applicator [tube] upright and snap tip back, away from face and body. 3. The dog should be standing foreasy application. Apply RF2164AIT COMBO evenly to [two spots](toydogs)[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 ofthe solution on the skin. Do not apply an excessive amountofthe solution at anyone spot that could cause some of the solution to run offthe side ofthe dog. 4. Do not spread RF2164 AIT COMBO by hand overthe 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 for30 days unless re-treatment is required, but notsooner than 8 days afterthe initial treatment. Do not retreat more than once permonth. {Note: Each package contains sufficient tubes/applicators for [X] applications] FOR [LARGE][EXTRA LARGE] DOGS 

### 1. Bend at perforation and tear offfirst applicator [tube]. 2. Hold applicator [tube][and bend area of plastiC at perforation, tearoffand discard.] Hold applicator [tube] upright and snap tip back, away from face and body 3. The dog should be standing foreasy application. Apply RF2164 AIT COMBO evenlyto four orfive 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 ofthe solution on the skin. Do not applyan excessive amount ofthe solution atanyone spot that could cause some of the solurlon to run offthe side ofthe dog. 4. Do not spread RF2164AIT COMBO by hand overthe dog. Although the dog's skin and hairoils 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 for30 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 ofa totalflea and tick management program. Use other [Brand Name] products registered for residential area control ofthese pests in conjunction with this treatment Monthly treatments are required for optimal control and prevention offleas. [The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs with RF2164AIT 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[TREATMENT SCHEDULE Dosaae: 1 rcartridaelrtubelrviall every 30 davs erdoQ Pet's Name FirstTreatment Date Second Treatment**~~te** Third Treatment**D~~e** (30 Davs From 1st (30 Davs From 2nd

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/FirstAid and StoragelDisposal) text included) WARRANTYAND CONDITIONS OF SALE: SeUerwarrants that this product conforms to the chemica! specifications expressed on the label. To the extent consistentwith applicable law, SeUer makes no otherwarranties, and disclaims all other warranties, express or implied, including but not limited to warranties ofmerchantability and fitness for the intended purpose. To the extent consistent with applicable law, seller's liabilityfordefault, breach, or failure underthis label shall be limited to the amount ofthe purchase price. Tothe extent consistent with applicable law, Sellershall have no liabilityfor consequential damages. In case ofemergency orfor product information, call 

### 1-BOO-xxx-xxxx orcontact your veterinarian ifyour pet is experiencing an adverse event.

Wellmark International 1501 East Woodfield Road 200W Schaumburg, Illinois 60173



### 18

# Wellmark"

June 14,2011
Richard Gebken, PM 13 Registration Division (AMEND) OfficeofPesticide Programs (7505P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington VA 22202 James McFadden, Ph.D.

Wettmark International



### Subject: SubmissionofLabel Amendmentfor a Product Containing Etofenprox: EPA Reg. No.2724·811; RF2164AIT COMBO
DearMr. Gebken: Enclosed with this letterplease find material to support a label amendment for Wellmark 

### International's productRF2164 AfT

### COMBO (EPA Reg. No. 2724-811). The purpose ofthis amendment is to add uses on puppies to the existing label. We are also making a minorrevision to the statementregardingpotential adverse effects. The basis for this amendment, however, is discussed at length in a concurrently submitted label amendmentfor a related product,Wellmark EPA Reg. No. 2724-796, theRF2042 [COSO]. That submission includes an additional report for review, revised datamatrix, etc. The label amendment for the 2724-811, RF2164 AfT COMBO depends entirely on thedatasubmitted with that application. Therefore, as far as we understand, this application (for2724-811) should be classified as a secondary submission underPRIA category R340.1, since we expect the other submission to be R340, and is the primary submission. A check in the amountof$904.25 (1I4th ofthe PRIA R340 fee) has been submittedto the government lockbox in S1. Louis, and a copy is enclosed withthis submission. Because supporting material was included with the submission for 2724--796, this application for a label amendmentcontains only: Form 8570-1, Application forlabel amendment Revised label (5 copies) Please let me know ifyou have questions orneed more infonnation regardingthis submission. Regards,

# ~~ :Gmes McFadden, Ph.D Sr. Regulatory Project Manager 

### Page 1of 1REGULATORY LABEL DATA SHEET


### File Name:
Product:


### Approved:

OVERVIEW:
Page 

### # 1·2

1·9 Epa amend add puppies 611 RF2164 

### AfT COMBO 

### Data SheetDate:
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][Monthlytreatment for control offleas, 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 setfor toy/small/medium and large/extra large dogs/puppies

1

# HF2164 AfT 

# COMBO [Textfor "Dog" must be samesizeas 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 ageor older Front Panel- For Use Only on DogS/Puppies 10 Weeks 6 months ofageorolder [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & Tick Control for Dogs & Puppies 10Weeks ofage orolder 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 naturallywith 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 andTicks by Contact] [Fresh][Clean][[Scent][Smell] [Reapply monthly] [Suitable for year-round use][Month] stickerfor home calendar [Satisfaction guaranteed oryour money back] [Patent Pending] [Incidental exposure of cats to this product is not likelyto 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 ofTicks for up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hours[[Kilis more than 50% offleas 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 maytransmit Lyme Disease Kills and Repels mosquitoes (the majorcarrier of canine heartworm-) Monthly application for mosl effective protection IGR Claims: [Contains an InsectGrowth Regulator (IGR) to kill flea eggs and prevent flea developm,:,'nt**'~6r** [more than 10weeks] upto [75 days][2.5 months[[ [Breaks Flea Life Cycle for [more than 10weeks[ 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]

1Applicator Claims ]New] [applicator] [New] contemporary design [brand name] [Applicator] helps to prevent getting liquid on ]your] hands [brand name] [Applicator] tip parts hairto 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]]providesllallowsfor]]delivers] better grip [brand name][provides] re-closable [re-sealable] packaging for]easy] storage Closing [the][brand name][applicator] doorautomatically opens the [disposable][liquid dispensing] tube

[podllviamcartridge] ]brand name]]Applicator]]will not drip after opening] ]brand name] [Applicator] Won't dripwhen 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, easyto 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 Onefree month supply]dose] included Bonus pack Free]applicatorlltube][vial]cartridgeIIpodlllinside] Designed not to dripwhen 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

### 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

## RF2164 AIT COMBO IMPORTANT! DO NOT Use on Dogs LESS THAN 10 Weeks6 Months OLD READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGSAND PUPPIES. DO NOT USE ON OTHER ANIMALS! [Back Panel] DO NOT USE ON CATS 

### Keep cats awayfrom treated dogsfor 24 hours. Ifapplied or ingested, contactyour 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'tjust 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 everbefore. 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 allowthe 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

### [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 ofthis 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 applythe 

### [RF2164AfT 

### COMBO] treatment. useone 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 applicatorwith 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] Pointtip 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.

54. APPLY liGon] The dog/puppy should be Gtanding for easy appliGation. Apply RF2164 

### NTCOMSO 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 overthe 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 aftertreatment will help to distribute the material over the skin.

5. DISPOSE liGon] VI/hen finished, held applicator device evertrash. 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 offerfer' 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 emptytube into trash or offerfor 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- If necessary, product can be reapplied, but not soonerthan 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 shoulderto 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 RF2t64AfT 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 aftertreatment 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 perdog[/puppYI Pet's Name First Treatment Date Second Treatment Date**ThirdTr'33~ment** Date (30 Days From tst) (30 0"10 From 2"")

.

Reminder: Ipurchased RF2164 AfTCOMBO from:**NOTES:"C":'7C_~** __ _ Treatment table can be expanded based on package size. (6 months)

7

### 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 offerfor recycling if available. If partiallyfilled: 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. FIRSTAID If in eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, if present, afterfirst 5 minutes, then continue rinsing 

# • Call a poison control center or doctorfor 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 otherwarranties, 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 liabilityfor 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

8TEXT 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 Onlyon 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) Wellmark International 1501 East Woodfield Road 200W Schaumburg, Illinois 60173

9

### 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 applicatorwith tip end oftube placed under on door

Gently CLOSE the door and the tube will snap open. To APPLY Usetip to partfur 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) 

### 10AcHon Code History Secondary Decision

# PRIA2 - 21 Day Content ScreenReview Worksheet (EPNOPPUse Only) 3/23/09 

### 21 Day ScreenStartDate: ((,

- 

### I 7

- 

### II Experts In-Processing Signature: 

## nr

# I~A;f.IN6;o"" Date G-Z/- 

### 1/ Fee Paid: Yes

# ~ Division management contacted onissues No Yes Date

______ _
EPA Reg. Number: 

## 2. 7 L 

# '-I_ £ { I EPAReceipt Date: 

# c, - /7- / ItemsforReview 

### Yes No N/A*


### 1

2

3 ApplicationForm (EPA Form 8570-1)(1ink to form) signed & 

### complete includingpackagetype
Confidential StatementofFormulaall boxes completed, fonn signed, 

### mld dated Fonn to a) All 

### inerts (link to http://www.epa.gov/opprdOOllincrts/), including fragrances, approved for the proposeduses (see Footnote Certification with Respectto Citation ofData (EPAForm 8570-34) (Link to form) completed and signed (N/A

### if 100% repack) Certificate and data matrix consistent Ifapplicant is relying on data that are compensable, is the offer to pay statementincluded. (see Footnote B) 

### yes no

# ~~-t~~~~~~;:~~~O~f~~~ I 4 completed and (N/Aifsomce is umegistered orapplicant owns the



### 5

6 DataMatrix (EPAForm 8570-35) (Link to form) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed 

### (NIA if 100%

SelectiveMethod b) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use)
5 CopiesofLabel (linkto http://www.epa.gov/oppfeadl/1abelinglIrml) (Electroniclabels on CD are encouraged andguidance is available)(link to \..- http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#labels /\



### 1 

# x

### 7 Is thedata packageconsistentwith PRNotice 86-5 (link to PRN 86-5) -,( 

### Notice ofFiling(linkto 

### 8**htt~://www.eQa.gov/l!esticides/regulating/tolerance** 

### Qetitions.htm) included with petitions (liukto 

# )( htlp:!lwww.epa.gov!pesticidesJregulating/tolerances.htm) 9 If

### applicablefor conventional applications, reduced risk rationale (linkto 

# \ http://www.epa.gov/opprdOOllworkpian/reducedrisk.html) RequiredData Clink to httl!

### ://www.eRa.gov'I!esticides/reguiatin

### eIdata 

### reguirements.htm) and/or datawaivers. SeeFootnote 

### C.

a) 

### List study (or studies) not included with application

10



### 2

### 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 contentreview, all CSFs will be reviewed to determine whetherall illerts listed, including fragrances, are approved for the proposed uses. Ifan 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 ofthe inert or 3) withdraw the application. Removing orsubstitutingan inert ingredient will require a new CSF and mayrequire submission ofdata. All information, forms, data and documentation resolving the inert issue musthave beenreceived bythe 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 ofthe 21 day initial content screen, applicants are strongly encouraged to verifythatall inert ingredients have been approved for the application's uses even ira product 

### is currentlyregisteredbyconsulting the inert Web 3

### site [linkto http://www.epa.gov/opprdOOllincrts/list.s.html] and ifthe inert is not approved, to obtain thenecessaryinertapproval priorto submittingan application to register a pesticide product containingthatinertingredient. Some inert ingredients are no longer approved for food uses orcertain types ofuses. Thename and/or CAS number on a CSFmustmatch the name and CAS number on this web site. Simpletypographical errors in the name or CAS numberhaveresulted in processing delays. Ifan inert is not listed on the inert ingredient web site and the applicant believes that the inert has been approved, the applicant should contactthe Inert Ingredient Assessment Branch (IlAB) at illertsbranch@epa.govandresolvetheissue. Copies ofthe correspondence with IIAB resolving the issue should accompany the application. All new inerts exceptPIPinerts arereviewedbylIAB. The lIAB should also be contacted for anyquestions on what supporting data needs to be submittedfor and the Agency's inert review process. Questions on PIP inerts should bedirected to the Chiefof Microbial Pesticides Branch [Link to http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm]. When a brand, trade, orproprietary name ofan inert ingredientis listed on a CSF, additional infonnation such as an alternate name ofthe inert, CAS number or other information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also beincluded to enablethe Agencyto detennine ifit has been approved. Eachcomponent ofan inert mixture (including a fragrance) mustbe identified. In somecases, the supplier ofthe mixture or fragrance mayneed to provide this information to the Agency. Priorto the Agency's receipt ofan application, applicants must anange with a proprietary mixture or fragrance supplierto provide the component information to the Agency orpromptlyupon EPA'srequest. Ifthe inert ingredients in aproprietaryblend (including fragrances) cannot or are not identified orprovided within the 21**~day** 

### contentreview period, the Agency will reject the application. Duringthe 21 daycontentreview, applicants should submitinformation to the individual identified bythe Agency when the applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications exceptconventional new products and PIPs Once anunapproved inert is identified ona CSF, the Agency will contact the applicant with the following options: 1. Correct the applicationby, for instance, correctingthe inert's identity orCAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSForreplacing it with onethat is approved for the application's uses; or 2. Submitthe infonnation and data needed for the Agencyto approve the unapproved inert. Ifthis 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

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedby the applicant within the 21 day content review period, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional New Product Applications When the Registration Division identifies an unapproved inert on a CSF with an application for a new productthat 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 inerthas been approved, or removing the unapproved inert from the CSF orreplacing 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 toleranceorexemption from a tolerance. (This option may change the PRIA category for the application, which could require a longerdecision review time and a larger fee. Ifadditional fees are due, they must be received bythe Agency within the21 day contentreview period.) 3. Withdraw the application (the Agency retains 25% ofthefull fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the 2l-day contenHeview period, theAgency will reject the application and retain 25% of the appropriatefee for the new product-inert approval category. PIP Applications Whenthe Biopesticide and Pollution Prevention Division identifies an unapproved inert on a PIPCSFand 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 ofthe inert to that in 40 CFR 174, or providing documentation that the inerthas been approved; or 2. Submitthe information and dataneeded for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemption petition is required, the petition mustbe received by the Agency and the B903 fee paid within the21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 

### 5

### 3. Withdraw the application (theAgency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthe 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 ondocumentation ofoffers to pay is still being developed, however, for a me-too or fast track (similar/identical) new product, R300 orA530, an application without the necessary authorizations ofoffers to pay will be placed into either R30I or 

### A531. The Agencyrecommends that authorizations ofoffers to paybe submitted with otherPRIA applications to avoid delays inthe Agency's decision. C. 

### Biopesticide applicants are advised to contact the Agency and discuss study waivers priorto submitting their application to theAgency. Documentation ofsuch discussions should be submitted with the study waiver.



### 6UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### June 21, 2011

OPPDecisionNumber: D-450780 EPAFile Symbol or RegistrationNumber: 2724-811 ProductName: RF2164

### NT COMBO EPAReceipt Date: 17-Jun-2011 EPA CompanyNumber: 2724 CompanyName: WELLMARKINTERNATIONAL JAMES MCFADDEN, PH.D. WELLMARKINTERNATIONAL 1501 E. WOODFIELD ROAD, SUITE 200 WEST SCHAUMBURG, IL 60173 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration Amendment Subjectto Registration Service Fee DearRegistrant: The Office ofPesticide Programshas received your amendment and certification of payment. If

### you submitted data withthis application, theresults ofthePRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticidePrograms has detennined thatthis Action is subject to aPesticide Registration ServiceFee as defined in the Pesticide Registration Improvement Act. The Action has beenidentified as Action Code: R340.0 NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTIONARYLABEL STATEMENTS;NO FEE: LINKED TO A PRIAAPPLICATION; The fee for this action is $0. Youhave paid $904.25 towardsthis action (Check No. l068403). This amount will be refundedto youwhenthe action is completed. Ifyouhave any questions, please contact the Pesticide Registration ServiceFee Ombudsman at (703) 308-9362. Sincerely,

## ~**~** FrontEndProcessing Staff Infonnation Technology & 

### Resources Management Division

# IFee for Servicel 

# ("1{898013Er------------------------------------------------------------------------------- 

## This package includes the following


# o New Registration @Amendment for Division 

# OAD oBPPD @RD I'ii 

# Studies? DFee 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:Please read instructions onreverse before completingform FormApproved OMS No 2070 0060 Approval expires 228 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 !

,

- , 

# o None 4. CompanylProduct (Name) PM' I 

# D Reslricted

Wellmark International/RF2164AfT Combo 13 i**~~~-----~-~-~--~-** i 5. Name and Address ofApplicant 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 ifrhis isa new address , Section

- II 

# D Amendment
- Explain below.**~** Final printed labels in response '0 M?rch 9, 2['11 Agency letterdaled 

# D Resubmission in response to Agency letterdated 

# D "Me Too" Application**~~~--.--** --------

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

# D Nolif,cation

- Explain below. 

# D Olher

- Explain below. 

### .-'-_._. ----_._---**--.-..!--~~~** Explanation: Use**addi~onal** pagels) il necessary. (Forsection Iand 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 ofthe 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 ofContainer 

# By" @Y"**~~lli'** 

# @y" X No X Plastic No X "'

-------- '''--''-'---

### -_

...- -------- --------i Glass

..**--~~--** ..**----~~--** If"Yes Unit No. per i If'"Yes Unit No. per X Paper * Certmcation mustbe 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
- 0.30fl 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 Paperglued**~- ---~~--**  Slenciled Section -IV 1. Contact Point ICompleteitems directlybe/owfor**i~!!.nrificati0r:.** ofindividualto be contacted, ifnecessary, to process this application.)**~** Name : Title Telephone No. (Include Area Codel James McFadden Sr. Regulatory Project Manager 847-330-5376**~--~~--~.--. -----.---~~~-."** .. .__.

### __._..-**---~~- -~~----**  - -**----~------** - ---..**~-.----** .. ..

### _--- ._._.- Certification 6. DaleApplicalion Icertify that the slatemenls Ihaue 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) underapplicable 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

# Wellmark"

June 14, 2011
Richard Gebken, PM 13 Registration Division (AlvlEND) Office ofPesticide Programs (7505P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 SouthCrystal 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 ofLabel Amendmentfor a ProductContainingEtofenprox: EPA Reg. No. 2724·811; RF2164 AIT COMBO


### DearMr. Gebken: Enclosed with this letterplease fmd material to supporta label amendment for Wellmark International's product RF2164 AffCOMBO (EPA Reg. No. 2724-811).**~he** purpose ofthis amendment is to add uses on puppiesto the existing labeL We are also making a minorrevision to the statement regarding potential adverse effects. Thebasis for this amendment, however, is discussed atlength in a concurrently submitted label amendment for a related product, WellmarkEPA 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 AffCOMBO depends entirely on the data submitted with that application. Therefore. as far as weunderstand. this application (for2724-811) should be classified as a secondary submission underPRLA category R340.1, since weexpectthe other submission to be R340, and is the primary submission. A checkin the amount of$904.25 (l/4th ofthe PRLA R340 fee) has been submitted to the governmentlockbox in St. Louis, and a copy isenclosed with this submission. Becausesupporting material was included with the submission for 2724-796, this application for a label amendmentcontains only: Form 8570-1, Application for label amendment Revised label (5 copies) Please let meknow ifyou have questions or need more infonnation regarding this submission. Regards,

# L~**~~~'McFadden,** Ph.D Sr. RegulatoryProject Manager

# Wellmark"

June14,201l
Richard Gebken, PM 13 Registration Division Document ProcessingDesk Office ofPesticide 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 ofLabel Amendmentfor a ProductContaining 1i:tofenprqx: EPA Reg. No. 2724-796; RF2042 (CDSO) 

### Contains Confidential Business Information (Discussion ofInert Ingredients)
DearMr. Gebken: Enclosed with this letter pleasefind material to supporta label amendmentfor Wellmark International's product RF2042 (CDSO) (EPAReg. No. 2724-796). The purpose ofthis amendment is to add uses on puppies back to theexisting label. Afterthe RF2042 (CDSO) was registered, (3/10/2009) thecompanion animal safety study for puppies was rejected, (MRID47622203, DP Barcode DP 360171) forcing us to delete thatuse from the productlabel. Since the initial rejection ofthat study, Wellmarkhas made several attempts to get puppies added back to the label. Wellmarksubmitted a report amendment (MRID47835301, 8/24109) that addresses issues identified bytheTechnical Review Branch (TRB) in the reviewfor the original puppy companion animal safety study; the issue has also been discussed in otherletters and in a meeting with EPA in January of2010. This submission collects the arguments submitted previously, provides an additional report as supporting data, and ties all ofthis to a request to approve specific label language submitted with this label amendment. Because this submission will not require review outside ofRD, we expect the submission will be classified as PRIA category R340, and will have a 4-month review time. PRIAcategory 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 of5Label Amendment, 2724-796
Theapplication for label amendment includes the following components: Form 8570-1, Application for label amendment Revised label (5 copies) Form 8570-34, Certification with Respectto Citations ofData Form 8570-35, Revised Data Matrix Transmittal Document for one study submitted with this application The following paragraphs discuss this submission in more detail: Backgroundfor theAmendment 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 ofthis amendment.
Date Action/Issue Data 3/10/2009 Notice ofRegistration OriO'inal submission



### -- 6/04/2009 Amend to Remove Puppies, CAS Study rejected MRID 47622203, DP360171 (study oriO'. submitted with 2724-797) (dated 5/2212009) 8/24/2009 CAS ReportAmendment, 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 Amendmentto change dosegroups approved, DP 369326, 12109/2009 safety to cats not approved 112812010 MeetingwithEPA to discuss pet issues and MRID 47835301, EPArecommended submission ofa PRIAaction. 2124/2010 Amendment to addpuppies and kittens to pet spray DP376421, 6/23/2010 (review submitted, also requested review for 2724-796 did notconsider2724-796) CAS

# =Compamon Anlmal Safety FromDP 360171. 5/2212009, where EPArejected the puppy companion animal safety study: TRB's primary concern is that adverseeffects

- even though they couldbe considered as minor (loose feces and vomiting)

- occurred following IX exposure (use application rate) to the testmaterial. Consideringthatonly 12puppies were tested at 1X, the occurrenceofeffects in two indicates a high potential for adverse incidents

- includingsome ofgreater severity

- ifthe formulation is registered for use as a spot-on for puppies. Even ifnothing abnonnal hadbeen observed at IX, the occurrenceof adverseeffects at3X (one male hada 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 3Xmargin ofsafety for this use on puppies. Sincethere 

### is an inadequate margin ofsafety, the study is classified as unacceptableandcannotbeused to support the use ofthis formulation as a spot-on for puppies. From DP 369326. 12/09/2009, where EPA raised additional concerns about the dogtopical: 2. Although the material inMRID 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) ofa 40% Etofenprox and 3.6% S-methoprene containing formulation. These incidents include a total (for2008) of82 deaths (by all exposure routes) in cats orkittens. In addition, thepresence oflanolin in 2724-796 creates a potential problem, as some cats (particularly Siamese) may be attractedto lanolin (see http://www.messybeastcomipica.htm). and may go out oftheir way tolick lanolin-treated items. Itis also noted that 2724-504 does not contain
Page20f5

### Label Amendment, 2724-796 piperonyl butoxide, which is present in 2724-796 and which could enhance the toxicity ofthe etofenprox to the cat. Based on these considerationsTRB 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 ingestthis productby lickingorgrooming 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 ofeffects observed at IX in the spot-on puppy study (one incidentofloose stools on Day 3 and one incidentof vomiting afterthe second dose) in conjunction with the reduced exposure to actives, TRB concludes that this study is acceptableto supporta spray-on use of2724-797 at an application rate of8 glkg or lowerto 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 similarto adverse events in IX applications ofregistered prodl,c:ts 

### 1'1 addition', potential concerns related to attractiveness to cats appearto be anecdotal, and not legitimate. Review ofthe 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 oftest material administration forthis animal. And, a single observation ofvomit W'l<; 

### recorded in one female Day 9. Since both loose stools and vomit are common clinical observations in laboratory puppies, the significance ofthese observations was further investigated. APSS sc:u,t;:,t" reviewedthe clinical observations reported in the study. The evaluation included statistical analysis of the gastrointestinal signs in this study and areview ofthe incidence ofgastrointestinal signs in the APSS public adverse reaction database. The statistical evaluation showedthat the increase in gastrointestinal signs was statistically different from thecontrols only at the 5Xdose and that the occurrence ofthese signs at the 5X dose were similarto what is reported to ASPCA leadingto the conclusion that (Hansen 2009) "The occurrence ofmild gastrointestinal signs following high dose (5X) exposure to JM982 spot-on in puppies is similar to reported signs following appropriate use (IX) ofEPA registered and currently marketed spot-on formulations containing active ingredients other than etofenprox". Based on analysis ofthe adverse reaction type and frequency reported to theASPCA, occasional gastrointestinal signs are a commoncomplaint (19.1% 

### oftotal) in currently registered products. Since statistically significant effects compared to controlsoccurred only at the 5Xlevel and not at IX or 3X, and the effects seen at5X are similarto current products, it is expected thatthe product(s) supported by this study do have an acceptable margin ofsafety. 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 EPAcontain material (suggestionsofpotential risk due to lanolin l ) 

### do not appearto be adequately supported. This current submission for a label amendment requests re-evaluation ofpreviously submitted data, as well as evaluation ofa new study which reaches similarconclusions.

1

### In addition, the properties ofraw !anolin may be very different from the properties ofthe materia! used as an inert ingredient in the formula for 2724-796. Page 

### 3of5

### Label Amendment, 2724-796

Content ofThis Submission: With this proposed label amendment, Wellmark is submitting a review ofadverse incidentdata (Petree andMcFadden, 2011) for the 2724-796 product; including adverse events due to misapplication to puppies. IftheEPA'sconclusions in DP 360171 (5/22/2009) 

### are correct, adverse events in puppies should show an increased rate ofincidents with gastrointestinal signs. Instead, the review ofAdverseEffect Incidents provided with this submission finds that: • The distribution ofseverity ofadverse events in puppies (due to misapplication) for the etofenprox product was betterthan for a permethrin productthat allows applications to puppies. • No elevation ofdigestive systemevents in puppies was found for the etofenprox product when compared to two permethrin dogtopicals. • Instead, thedistribution ofmild clinical signs for puppiesfor the etofenprox product was found to be similar (not statistically different from) the distribution ofmild clinical signs in adult dogs. The review ofadverse effect incidentdata showsconclusively thatthere is no safety hazard assudated with the use oftheetofenprox topical product on puppies. Even though thecurrent label does 

### not permit application to puppies, events dueto 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 ofa very large scale performance monitoring study. Millions of**prodJ.~~** 

### J0ses were sold, and even though the total number ofapplications to puppies is unknown, this analysis represents a much larger sample than one could obtain even in any clinical study. Notably, the summary conclusion ofthis analysis ofincidentdata is similarto thatreached if! the Hansen (2009) report (in MRID 47835301): (1) 

### there is no evidence ofa higherfrequency ofadverse events with gastrointestinal signs and (2) the etofenprox productappearsto have an acceptable margin ofsafety. In addition, this new analysis documents thatthe etofenprox spot on has at leastthree significant benefits for the etofenprox spot on productcomparedto the permethrin product: The total rate ofadverse incidents was lower Therate ofincidents in cats was much lower Therate ofincidents 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 documentingthatthere is an acceptable margin ofsafety in puppies, the analysis ofincident datadocuments thatthe etofenprox product has an improved safety profilecomparedto permethrin products. Because ofthis improved safety profile, Wellmark believes that some form of label language reflecting these facts should be permitted by EPA, sinceit is in thebest interests ofthe EPA to allow consumers to make an educatedchoice. (Previous attempts to address this issue have been rejected by EPA) Specific ChangesProposed in theLabel Amendment Tohighlight specific changes proposed in the revised label and provide additional explanation, we wanted to notethe following specific points in addition to the addition ofpuppies to the label:

• Textto comply withTopical RiskMitigation 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 includereference to the most prominent adverse effect (which is deonal irritation) in theprecautionary statements. Page 4 of5

### Label Amendment, 2724-796

• A section on "Use Restrictions" as per the PBO RED DCI has been added, as well as modification ofreference to PBO in the Ingredient statement. • A section oftext was added for the textto be included on the individual applicator. • One efficacy-related claimwas added: "Controls fleas ticks and mosquitoesforup to one month". Even though efficacy datadoes not support a "kills" claimwith 90% efficacy for one month, the overall effect in some animals in efficacy tests did supportcontrolup to one month, so, in ourview, this claim(while less strong) is supported by the existingefficacy data. • Wellmark believes the safety ofthis product for cats is documented in the analysis ofadverse effect incident datathat was included with this submission, and believes that some statement acknowledgingthat record is appropriate for addition to the label, in orderto allow customers to make an informed choice. While the exact nature ofthat statement may need to be negotiated with the EPA, we areproposing several statements thatcould reflect the safety record that has been documented:

- Incidental exposure ofcats to this product is not likely to cause harmful effects

- Canbe used in households with dogs and cats

- Based on testing, accidental exposure to cats from this product is notlikely to caUSe :,clinus harmful effects.

Please let me know ifadditional information is needed orthere are questions ab,mt**lhj~** 

### subMissi('n.
Regards,

# ~~ Sr. Regulatory Project Manager

Page 5of5

### TRANSMITTALDOCUMENT 

### 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 

### ProductName, RF2042 [CDSO]; EPAReg. No. 2724-796 3. TRANSMITTALDATE June 14,2011 4. LIST OF DOCUMENTS SUBMITTED 48511701 1. Petree, L. 

### and McFadden, J. 

### (2011) Analysis ofAdverse Effect Incident Data ;or

### RF204'2 [CDSO], EPA Reg. No. 2724-796, unpublished, Wellmark International St>ldy 

### No. 4043, 22 pp. 

### 5. COMPANYNAME 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 1of1INVOICE 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".

# ",f2164AfT

# COMBO [Textfor"009" must be same size as Brand Name] Front Panel**~** For Use Onlyon 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 ofage or older Front Panel- For Use Onlyon Dogs/Puppies 10 Weeks ofage orolder [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks ofage orolder General Claims: [Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 5 size categories providejsmailerj 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 naturallywith 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] [Suitablefor year-round use][Month] stickerfor 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 notlikelyto 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]]Fourf4Week [Flea]rrick][Mosquito] Treatment] [Controls fleas, ticks and mosquitoes for up to one month] [Monthlytreatmentfor control offleas, ticks and mosquitoes] [Aids in Control ofTicks for up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hours][Kills morethan 50% offleas in 2 hours] [Dual Action kills adultfleas and prevents flea development] [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection [againstfleas and ticks)] Kills the Deer Tick, which maytransmit Lyme Disease Kills and Repels mosquitoes [the major carrier of canine heartworm) Monthlyapplication for most effective protection IGRClaims: [Contains an Insect Growth Regulator [IGR) to kill flea eggs and preventflea developMentfor [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 10weeks] up to [75 daYS][2.5 months] [With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle]



### 1Applicator 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] getdown to [the][your][dog's/puppy's] skin ErgonomicalJy contoured [ergonomic][shape][design] for easy handling [ease of use] [easy use] For usewith [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 notdrip after opening] [brand name] [Applicator] Won't drip when setdown as you gofetch the [your] dog/puppy Includes unique [brand] applicator Puts the liquid on your dog/puppy

- notyour hands Directs the liquid onto your dog[lpuppy]- not your hands Directs the liquid onto your dog[/puppy]- awayfrom your hands Applies liquid to your dog's[/puppy's] skin
- notyours Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet Convenient, easyto useACCU-TIP [Applicator] [DISPENSER] ]Easyto use] Longer applicator tip for easyapplication 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 Onefree month supply [dose] included Bonus pack Free [applicator][tube][vial[cartridge][pod]][inside] Designed not to dripwhen set on top ofthe 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 intext) Applicator Tool Device Applicator Device Application Tool



### 2Thermoform name options (tube. cartridge andvial 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

## 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 OTHERANIMALS! [Back Panel] DO NOT USE ON CATS 

### Keep cats awayfrom treated dogsfor 24 hours. Ifapplied or ingested, contact your veterinarian immediately. [RF2164

### NT COMBO] prevents flea eggs from developing into adultfleas [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 foryourdog/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'tjust 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 applicatorforyou
.... 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] foryourdog/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 hairto 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, counteror otherflat surface, it won't run out or drip. DlRECT!ONS FOR USE: !t is a violation of Federal Lawto usethis 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 directlyto 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] hairto 

### 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] perdog[/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[Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] [DFU Set No. 1J FOR [TOy][SMALL][MEDIUMJ SIZE DOGS/PUPPIES To applythe 

### [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 applicatorwith front of tube placed under tab on door. -[To Load, place tube [cartridge][vial] white side up into the[open] applicatorwith tip end of tube placed underthe [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 ofthe tail. Do not apply an excessive amount of the solution at anyone spot that could cause some of the solution to run offthe 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 aftertreatment will help to distribute the material over the skin. 5. DISPOSE [icon] [When finished, hold applicatordevice overtrash.] To dispose of emptytube, open [color, e.g. green] doorand drop empty tube into trash or offerfor 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 soonerthan 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 afterthe initial;treatr'lcrit. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applicatioi13J



### 5FOR [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 ofapplicator][tip] to part hairand get next to dog's/puppy's skin. Press [circle] [[round] thumb pad] on green door [number-once] at each offour or five evenly placed spots between the shoulder to the base ofthe tail. Do not apply an excessive amountofthe solution at anyone spot that CQuid cause some ofthe solution to run offthe side ofthe dog/puppy. Do not spread RF2164

### AfT COMBO by hand over the dog/puppy. Although the dog's/puppy's skin and hairoils 

### will naturally distribute the application over the entire dog/puppy, brushing the dog/puppy 12-24 hours aftertreatment 

### 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 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 offleas. [The successive feeding activity offleas on dogs/puppies may elicita hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs/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: 1icartridQe (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 awayfrom children' and animals. Liquid Cartridge [vial][tube] Disposal: Ifempty: Do not reuse cartridge {viaf] {tube]. Place in trash or offerfor recycling ifavailable. If partiallyfilled: cal: yo';Jr'local ,'5olid waste agencyfordisposal instructions. Never place unused product down any,jrvj00r or outdoor drain.



### 6PRECAUTIONARY STATEM. ,TS HAZAROS TO HUMANS ANO OOMESTIC ANIMALS

- CAUTION 

### 00 NOT USE ON DOGS/PUPPIES lESSTHAN 10 WEEKS OLD. For external use only. Causes moderate eye irritation. Avoid contact with eyes orclothing. 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, oranimals on medication. Sensitivities may occur after using ANY pesticide product for pets. Ifsigns ofsensitivity occur, bathe your dog with mild soap and rinse with large amounts afwater. Ifsigns continue, consult a veterinarian immediately. Some dogs may experience hair loss ortemporary skin irritation at the application site. Ifsigns persist or become more severe, contact veterinarian immediately and report incident to company at 1-800-XXX-XXXX. FIRSTAID Ifin eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, ifpresent. afterfirst 5 minutes, then continue rinsing 

# • Call a Doison control centerordoctorfortreatment 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. WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistentwith applicable law, Seller makes no otherwarranties, and disclaims all other warranties, express or implied, including but notlimited to warranties ofmerchantability and fitness for the intended purpose. To the extent consistentwith applicable law, sellers liabilityfor default, breach, or failure under this label shall be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Seller shall have no liabilityfor consequential damages. In case ofemergency orfor product information, call 1-800-xxx-xxxx or contact your veterinarian ifyour pet is experiencing an adverse event. Wellmark International 1501 E. Woodfield Road. 200W Schaumburg, Illinois 60173 fURL] Made in USA



### 7TEXT 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 Onlyon 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 ofage orolder [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 inconsistentwith 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. Ifyou need directions for application, please call1-BOO-XXX-XXX)<. (Precautionary and Storage/Disposal) text included) Wellrnark International 1501 EastWoodfield Road 200W Schaumburg, illinois 60173



### 8Icon Set for the RF2164 

### AfT COMBO 

### [ICON SET 1]
Directionsfor 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 applicatorwith tip end oftube placed undertab on door

Gently CLOSE the door and the tube will snap open. To APPLY Use tip to partfur 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

## KF2164 AIT COMBO [Textfor "Dog" must be same size as Brand Name] Front Pane!
- For Use Onlyon 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 ofage orolder Front Panel- For Use Only on Dogs/Puppies 10 Weeks ofage orolder [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks ofage orolder 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 naturallywith 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] stickerfor home calendar [Satisfaction guaranteed oryour money back] [Patent Pending] [Incidental exposure of cats to this product is not likelyto cause harmful effects] [Can be used in householdswith 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 offleas, ticks and mosquitoes] [Aids in Control ofTicks for upto 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hours][Kills morethan 50% offleas in 2 hours] [Dual Action kills adultfleas and prevents flea development] [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] [Dual protection (againstfleas and ticks)] Kills the DeerTick, which maytransmit Lyme Disease ' " , Kills and Repels mosquitoes (the major carrier ofcanine heartworm) Monthly application for most effective protection IGRClaims: [Contains an Insect Growth Regulator (IGR) to kill flea eggs and preventflea developmentfor [more than 10 weeks] up to ]75 days][2.5 months]] [Breaks Flea Life Cycle for [more than 10weeks] up to [75 days][2.5 months] [Controls flea reinfestation for [more than 10weeks] up to [75 days][2.5 months] [With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle]



### 1Applicator Claims [New] [applicator] [New] contemporary design [brand name] [Applicator] helps to prevent getting liquid on [your] hands [brand name] [Applicator] tip parts hairto 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 usewith [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 gofetch the ]your] dog/puppy Includes unique [brand] applicator Puts the liquid on your dog/puppy- notyour hands Directs the liquid onto your dog[/puppy]

- not your hands Directs the liquid onto yourdog[lpuppy]- awayfrom your hands Applies liquid to your dog's[/puppy's] skin
- notyours Helps prevent applying the wrong spot-on [dose] [product] on [to] the wrong pet Convenient, easyto useACCU-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 Onefree month supply [dose] included Bonus pack Free [applicator]]tube][vial[cartridge][pod]]inside] Designed notto drip when set on top ofthe counter, or table, or otherflat 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

### 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

## 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 awayfrom treated dogs for 24 hours. Ifapplied or ingested, contact your veterinarian immediately. [RF2164

### AfT COMBO] prevenls flea eggs from developing into adultfleas [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 foryourdog/puppy. [brand] provides flea and tick protection for dogs/puppies for upto**30~days** - and protection from flea reinfestation beyond. That's because 

### it doesn'tjust 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 foryou
.... 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] foryour dog/puppy into the applicator, close it and squeeze to apply. The applicator's ergonomic, contoured shape [design] makes it easyto 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 yourdog[/puppy]

- and notyour hand. Plus, ifthe applicator is laid down on a table, counteror other flat surface, it won't run out ordrip. DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in a manner inconsistentwith its labeling. Read and follow all directions and precautions on this prodJ'ct label. USE RESTRICTIONS: Applythis product once every 30 days unless a retreatment is necessary. Do not make:!h-; retreatment soonerthan 8 days afterthe initial treatment. Do not retreat more**!Ii~m** once per month. RF2164 AfT COMBO works by application directlyto the dog's[/puppy's] skin, not to the i)air

.. When applying, use applicator device tip to push aside dog's[!puppy's] hairto 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 applicatordevice that allows dog/puppy owners to treat their dogs/puppies more securely, and dispose of liquid cartridges [tubes][vials]with less mess.



### 4

### [Note: Each package contains sufficient cartridges/tubes/vials for [Xl applications[ [DFU Set No.1] FOR [TOy][SMALL][MEDIUM] SIZE DOGS/PUPPIES To applythe 

### [RF2164AfTCOMB01 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 applicatorwith front of tube placed under tab on door. -[To Load, place tube [cartridge][vial] white side up into the[open] applicatorwith tip end oftube placed underthe [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 tubewill snap open. 4. APPLY [icon] The dog/puppy should be standing for easy application. To apply, use [front edge ofapplicator][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 shoulderand the base ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog/puppy. Do not spread RF2164

### NT COMBO by hand overthe dog/puppy. Although the dog's/puppy's skin and hair oils will naturally distributethe application over the entire dog/puppy. brushing the dog/puppy 12-24 hours aftertreatment will help to distribute the material over the skin. 5. DISPOSE [icon] [When finished, hold applicator device overtrash.] To dispose ofemptytube, open [color', 'e.g'. green] doorand 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 soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]



### 5

### 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 offouror five evenly placed spots between the shoulder to the base ofthe tail. Do not apply an excessive amount of the solution at anyone spot that could cause some ofthe 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 treatmentwill 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 foroptimal control and prevention of fleas. [The successive feeding activity of fleas on dogs/puppies may elicita hypersensitivity skin disorderknown 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"C t"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 awayfrom children and animals. Liquid Cartridge [vial][tube] Disposal: Ifempty: Do not reuse

### car'ti-id~e;**[via~** [tube]. Place in trash or offerfor recycling ifavailable. If partially filled: Call you!'"h'\{,:al soad waste agency for disposal instructions. Neverplace unused productdown any indc:ror outdoordrain.



### 6PRECAUTIONARY 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 thoroughlywith 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 ofwater. Ifsigns 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. FIRSTAID Ifin eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, if present, afterfirst 5 minutes, then continue rinsing 

## • Cal! a poison control center ordoctorfortreatment 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. WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistent with applicable law, Seller makes no otherwarranties, 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 consistentwith applicable law, seller's liabilityfor default, breach, or failure underthis label shall be limited to the amount ofthe purchase price. To the extent consistentwith applicable law, Sellershall have no liabilityfor consequential damages. In case of emergency orfor product information, call 1-800-xxx-xxxx or contact your veterinarian ifyour pet is experiencing an adverse event. Wellmark Intemational 1501 E. Woodfield Road. 200W Schaumburg, Illinois 60173 [URLJ Made in USA



### 7TEXT 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 ofage orolder [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 inconsistentwith its labeling. Read and follow all directions and precautions on this product label. To applythe RF2164

### AfTCOMBO 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} applicatordevice. Make application according to label directions supplied with the [brand name} applicator device. Ifyou need directions forapplication, please call1-BOO-XXX-XXXX. (Precautionaryand Storage/Disposal) text included) Wellmark International 1501 EastWoodfield Road 200W Schaumburg, Illinois 60173



### 8

### Icon Set for the RF2164 AlT COMBO [ICON SET 1J
Directionsfor Use 

### For MaimD::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 applicatorwith tip end oftube placed under on door

Gently CLOSEthe door and the tube will snap open. To APPLY Use tip to partfur and get nextto 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

## r<F2164 AlT COMBO [Textfor "Dog" must be same size as Brand Name] Front Pane!**~** For Use Onlyon Toy (6-12 !bs.), Small ]13-31Ibs.), Medium]32-55Ibs.), Large]56 -80 Ibs.), and Extra Large]81Ibs. and over) Dogs/Puppies 10 Weeks ofage orolder Front Panel. For Use Only on Dogs/Puppies 10Weeks ofage orolder [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & Tick Control for Dogs & Puppies 10 Weeks ofage or older General Claims: (Note that claims previouslyapproved 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 naturallywith 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] [FastActing][Long Lasting][Kills Fleas and Ticks by Contact] [FreshllClean]]]Scent][SmeU] ]Reapply monthly] [Suitablefor year-round use][Month] stickerfor home calendar [Satisfaction guaranteed oryour 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/4Week [Flea][Tick][Mosquilo] Treatmenij ]Controlsfleas, ticks and mosquitoes for up to one month] ]Monthlytreatment for control offleas, ticks and mosquitoes] [Aids in Control ofTicksfor up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [KiUs 85% ofticks within 48 hours][Kills more than 50% offleas in 2 hours] [Dual Action kills adult fleas and prevents flea development] [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] ]Dual protection (againstfleas and ticks)] Kills the DeerTick, which maytransmit Lyme Disease Kills and Repels mosquitoes ]the major carrier of canine heartworm) Monthlyapplication for most effective protection IGRClaims: [Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development-!'or [more than 10weeks] 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]



### 1Applicator 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

[podllvialllcartridge] [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

- notyour hands Directs the liquid onto your dog[/puppy]

- not your hands Directs the liquid onto your dog[/puppy]

- awayfrom 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 notto drip when set on top ofthe counter, or table, or otherflat 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 intext) Applicator Tool Device Applicator Device Application Tool



### 2Thermoform 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

## 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 OTHERANIMALS! [Back Panel] DO NOT USE ON CATS 

### Keep cats awayfrom treated dogsfor 24 hours. Ifapplied 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 foryour dog/puppy. [brand] provides flea and tick protection fordogs/puppies for up to**30~days** - and protection from flea reinfestation beyond. That's because it doesn'tjust 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 applicatorforyou
.... The new [brand] Applicator is specially designed to make applying flea and tick control easier, more precise
-- and neater
- than ever before. You simply insertthe appropriate [brand] tube [vial][cartridge] foryour dog/puppy into the applicator, close it and squeeze to apply. The applicator's ergonomic, contoured shape [design] makes it easyto grip and a built-in fin [tip] [comb] helps to spread [part] the [your] dog's/puppy's hairto 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, ifthe applicator is laid down on a table, counteror otherflat surface, it won't run out ordrip. DIRECTIONS FOR USE: 

### It is a violation of Federal Lawto 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 soonerthan 8 days after the initial treatment. Do not retreat mor.J thar,**onc~**t>er month. RF2164

### NT COMBO works by application directlyto 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 RF2164AfT COMBO provides a unique applicator device that allows dog/puppy owners to treat theirdogs/puppies more securely, and dispose of liquid cartridges [tubes][vials]with less mess.



### 4

### [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] [DFU Set NO.1] FOR [TOY)[SMALL)[MEDIUM] SIZE DOGS/PUPPIES To applythe [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 applicatorwith front of tube placed under tab on door. -[To Load, place tube [cartridge][vial] white side up into the[open] applicatorwith 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 overthe 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 overthe skin. 5. DISPOSE [icon] [When finished, hold applicator device over trash.] To dispose of empty tube, open [color, E::.':;j.,

### green] doorand drop emptytube into trash or offerfor 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 afterthe initial**treatmo;,~.·** 

### Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]



### 5FOR [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 hairand 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 shoulderto the base of the tail. Do not apply an excessive amount of the solution at anyone spot that could cause some ofthe solution to run off the side of the dog/puppy. Do not spread RF2164

### Aff COMBO by hand overthe 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 offleas. [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 ofthis condition.] [RF2164 

### AfT COMBO iswater 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 AiTCOMBO 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: Ifempty: Do not reuse c<?rtri':ige [vial] [tube]. Place in trash oroffer for recycling 

### ifavailable. If partiallyfiJled: Ca:1 your locat**~oli{L** waste agency for disposal instructions. Never place unused product down arlY ;rluiloror outdoordrain.



### 6PRECAUTIONARY**STATE~**.. iTS HAZARDS TO HUMANSAND DOMESTIC ANIMALS

- CAUTION DO NOT USE ON DOGS/PUPPIES LESS THAN 10 WEEKS OLD. For external use only. Causes moderate eye irritation. Avoid contactwith eyes or clothing. Wash thoroughlywith 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, oranimals on medication. Sensitivities may occurafter using ANY pesticide product for pets. If signs of sensitivity occur, bathe your dog with mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately. Some dogs may experience hair loss ortemporary 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. FIRSTAID If in eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, if present, afterfirst 5 minutes, then continue rinsing 

## • Call a poison control center ordoctorfor 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. WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. 

### To the extent consistentwith applicable law, Seller makes no otherwarranties, and disclaims all other warranties, express or implied, including but not limited to warranties ofmerchantability and fitness for the intended purpose. To the extent consistent with applicable law, seller's liability for default, breach, or failure underthis label shall be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Seller shall have no liabilityfor consequential damages. In case of emergency orfor product information, call1-800-xxx-xxxx or contact your veterinarian ifyour pet is experiencing an adverse event. Wellmark Intemational 1501 E. Woodfield Road. 200W Schaumburg, Illinois 60173 [URLJ Made in USA



### 7TEXT 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 ofage orolder
[SUB-LABEL FOR REFILL CARTRIDGES] [Product Name] 

### [Flea & 

### Tick [& 

### Mosquitolrrreatment] [and] Control] Spot-On Flea & Tick Controlfor 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 ifspace 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 applythe 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. Ifyou need directions forapplication, please call1-BOD-XXX-.>e6o<: (Precautionary and StoragelDisposal) text included) Wellmark Intemational 1501 East Woodfield Road 200W Schaumburg, Illinois 60173



### 8Icon Set for the RF2164 AfT COMBO 

### [ICON SET 1]
Directions for Use ForMEditm 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 applicatorwith tip end oftube placed undertab on door

Gently CLOSE the door and the tube will snap open, To APPLY Use tip to partfur 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

## KF2164 AIT COMBO [Textfor"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 10Weeks ofage orolder Front Pane!
- For Use Only on DogslPuppies 10 Weeks ofage or older [Flea & Tick [& Mosquito][Treatment] [and] Control1 Spot-On Flea & TickControl for Dogs & Puppies 10 Weeks ofage 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] monthlytreatments] [1113114][6] Months Supply [24][48] doses Spreads naturallywith 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] ]FastActing][Long Lasting][Kilis Fleas and Ticks by Contact] ]Fresh lIelean ][[ScentlSmell] [Reapply monthly] [Suitable for year-round use][Month] stickerfor home calendar [Satisfaction guaranteed or your money back] [Patent Pending] [Incidental exposure of cats to this product is notlikely 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 3weeks] 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 treatmentfor control offleas, ticks and mosquitoes] [Aids in Control ofTicks for up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hours][Kilis more than 50% offleas in 2 hours] [Dual Action kills adultfleas and prevents flea development] [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae] ]Dual protection (against fleas and ticks)] Kills the DeerTick, which maytransmit Lyme Disease Kills and Repels mosquitoes (the major carrier ofcanine heartworm] Monthly application for mosteffective protection IGRClaims: [Contains an Insect Growth Regulator (IGR] to kill flea eggs and preventflea developrnertfor [more than 10 weeks] up to [75 days][2.5 months]] [Breaks Flea Life Cycle for [more than 10weeks] 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]



### 1Applicator 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][vial][cartridge] [brand name]]Applicator] [will notdrip after opening] [brand name] [Applicator] Won'tdrip when set down as you gofetch the]your] dog/puppy Includes unique [brand] applicator Puts the liquid on your dogJpuppy- not your hands Directs the liquid onto your dog]/puppy]- notyour 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, easyto useACCU-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 dripwhen set on top ofthe counter, or table, orotherflat surface. For usewith [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] monthlytreatments) [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] [tubellcartridge][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



### 2Thermoform 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

## 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 OTHERANIMALS! [Back Panel] DO NOT USE ON CATS 

### Keep cats awayfrom 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 foryour 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 

### itdoesn'tjust kill adultfleas and ticks, 

### it also prevents reinfestation by knocking out flea eggs and larvae that could hatch lateron. Plus, 

### it kills and repels mosquitoes. A unique, convenient applicatorforyou
.... 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} foryourdog/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, itwon't run out ordrip. 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 productonce 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. RF2164AIT COMBOworks by application directly to the dog's[/puppy's] skin. cet to the hai,. When applying, use applicatordevice tip to push aside dog's[lpuppy's} hairto 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 RF2164AfT COMBO provides a unique applicator device thatallows dog/puppy owners to treat theirdogs/puppies more securely, and dispose of liquid cartridges [tubes}[vials}with less mess.



### 4

### [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications] [DFU Set No.1] FOR [TOY][SMALL][MEDIUM] SIZE DOGS/PUPPIES To applythe [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] applicatorwith tip end oftube placed underthe [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 ofapplicator][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 ofthe tail. Do not apply an excessive amount of the solution at anyone spotthat could cause some ofthe solution to run off the side ofthe dog/puppy. Do not spread RF2164

### NT COMBO by hand overthe dog/puppy. Although the dog's/puppy's skin and hairoils 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 overthe skin. 5. DISPOSE [icon] [When finished, hold applicator device overtrash.] To dispose of empty tube, open [colo:-, e.g.: green] doorand drop emptytube into trash or offer for recycling ifavailable. [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 soonerthan 8 days afterthe initial treat/Cierlt. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]



### 5FOR [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 offour 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 ofthe dog/puppy. Do not spread RF2164

### AJT COMBO by hand overthe 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 aftertreatmentwill 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 1products registered for residential area control ofthese pests in conjunction with this treatment. Monthly treatments are required foroptimal control and prevention offleas. [The successive feeding activity of fleas on dogs/puppies may elicit a hypersensitivity skin disorderknown as flea allergydennatitis (FAD). Treatment of dogs/puppies with RF2164

### AfT COMBO rapidly kills fleas and may reduce the incidence ofthis 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 perdool/puppvi Pet's Name FirstTreatment Date**se~ond** Treatment Date Tnird Treatment**Dn~~e** 30 Davs From 1SI) 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 offerfor recycling if available. If partiallyfilled: Callyour local solie waste agency fordisposal instructions. Never place unused productdown ar:y :r:coor or outdoordrain.



### 6PRECAUTIONARY**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 orclothing. Wash thoroughlywith 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, oranimals on medication. Sensitivities may occur after using ANY pesticide productfor pets. Ifsigns of sensitivity occur, bathe your dog with mild soap and rinse with large amounts ofwater. If signs continue, consult a veterinarian immediately. Some dogs may experience hair loss or temporary skin irritation at the application site. Ifsigns persist or become more severe, contact veterinarian immediately and report incident to company at 1·S00·XXX·XXXX. FIRSTAID If in eyes 

# • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, if present, afterfirst 5 minutes, then continue rinsing 

# • Call a poison control center or doctorfortreatment 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: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistentwith applicable law, Seller makes no otherwarranties, 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 liabilityfor default, breach, or failure underthis label shall be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Seller shall have no liabilityfor consequential damages. In case of emergency orfor product infonnation, cal! 1-800-xxx-xxxx or contact your veterinarian ifyour pet is experiencing an adverse event. Wellmark International 1501 E. Woodfield Road. 200W Schaumburg, Illinois 60173 [URLJ Made in USA



### 7TEXT 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 Onlyon 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 ofage orolder [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 inconsistentwith its labeling. Read and follow all directions and precautions :::. 

### tl":i3**produc~** label. 

### To applythe RF2164 AfT COMBO treatment, use one disposable liquid cartridge [tube][vial][foreach application] with the applicator device. Remove one refill tube [cartridge][vial] from the package and insert into opened [brand name] applicatordevice. Make application according to label directions supplied with the [brand name] applicatordevice. If you need directions forapplication, please call1-BOO-XXX-XXXX. 

### (Precautionary and Storage/Disposal)text included) Wellmark International 1501 East Woodfield Road 200W Schaumburg, Illinois 60173



### 8

### Icon Set for the RF2164 AfT COMBO [ICON SET 1]
Directions for Use 

### For**~** D:gs

### (32 -55 Ibs) To apply the treatment, use applicatordevicewith ONLY ONE liquid tube per application **I** per dog



### Use to lift OPEN green door ", '



### To LOAD placetube WHITE side UP into applicatorwith tip end oftube placed under on door

Gently CLOSEthe door and the tube will snap open. To APPLY Usetip to partfUr and get nextto 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

# 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 offinal 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 ifyou 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

# --,nsttuctlons onreverse H recomp

# '''''' ' 

## "**.~.** F0=

# • _roveel OMS N 2O'1O-oOOGO Appr o. 

# ,,... ova exp res "**';n~ed** statoo

# ~ .legistration cppldenlifierNumber ft 

# EPA Environmental ProtectionAgency Amendment 

# 'C"", Wuhington, DC 20460 other A licationfor Pesticide
- Section I 1. CompanyJProduct Number 2. EPAProductMlnager 3. Pm\>OII$d ClassiflCiIlion Wellmark Inlernatiooa!J2724-811 Richard Gebken 4.ComponylProduct (Name) PM'**~None** 

# oRoolficted

Wellmark IntemationallRF2164AfTCombo 10
5. Name andAddressofApplicantf Regi&trani (IncludeZIPCode) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)

Wellmark International**(b)(~,** myproduct issimilaroridentical in composition and labelingto: 1501 EastWoodfield Road, Stlite 200W EPA Reg. No. Schaumburg, Illinois 60173 Product Name 

# D Chtx:kifthis Isa newat:1I:1root; Section -II 

# D Amondment
- Explain below. 

# o Final printod Iabolsin response 10 Agency leltordated March9,2011 

# o RasubmiSliion inresponoo 10 Agoncy lollordalod 

# D "MeToo· Application 

# o NotifiC3tlon· Explain below. 

# D Otlw·Explain below. Explanation: UseoddiliOflill page(s) If necoIRl3/y. (For oocIion I and MClion n.)

Section

- III 1. Material This ProductWill be PacXaged In: Child·Rooislanl Packaging Unit Packaging WaterSoluble Packagin 2. Type ofContainer 

# B:**~YOO**

# ~~"**~YOO** X No X Plastic X No Glass 

# "'00 Unit No. per '",00 Unil No."" X Papcr
• Cflrlificationmustbe Packaging wgl. cootainw- Packagingwgt
. cootainer Other (Specify) submlUod 

# , 3.localion of NetConlen!; Information 4. Size(s) Retail Conlairmr 1-'1S/PAcK: 5. Location of Label Directions



# 0

..."", 

# o Conlainor 0.05

_0.30 nOZ (1.5 - 9 ee) tubes,

### ~OnLabel On Label Accompanying Product 6. Mannerin Which label isAffl)((tlj to Product 

# § I./fuoomph**~** othor printedoncardboard 

## .... Papergll.lOd StencikKI 

# . Section-IV 1.contact Palm (Complete ftotM dfrecUybelowforfdontiflcation of fndfvfduaftobecontDckld, ffnecausry, 10proc(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. DaleApplicalion I certify lhallhestDlemonts: I have madeon thisform andall atlachmontstharetp are 1rue, accurate and complele. I . Received acknowledge Ihalany knowingtvfalseor mililoading slillementsmy bepunishable byfine or imprisonmentor both •(;;t'\amped) undorapplicable law.

# 'SYL~c;t!~ 3.TrlIe Senior Registration Specialist

4. Typed Name 5. Dale Nancy Huebt l1-Apr-11

EPA Form8570-1 (Rev.3-84)PreVIOUSethtlOIl$areobsolete. While_ EPA File Copy (ortglnal) Yellow- ApplicantcopyREGULATORY 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 barrierto" Per 3/9/11 EPA letter, 4.d.
- deleted "Innovative flea and tick

..," Net Contents: Per3/9/11 EPA letter, 4.L
- Added US measures EPA Reg No.
- per 3/9/1 t EPA letter, 4.g
- Revisedto 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.
- per3/9/t 1 EPA letter, 4.g
- Revised to 2724-811

" 

### _.-

. 

### ••



### -- -

# -

1

## 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) stickerfor 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 upto 30 days) [Starts Killing Reas and Ticks within 15 minutes] [Starts worl,ing in 15 minutes [lasts up to ao days] [Kills 85% ofticks within 48 hours][Kills more than 50% offleas in 2 hours] [Dual Action kills adultfleas and prevents flea development) [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae[ [Dual protection (against fleas and ticks)] Kills the Deer Tick, which maytransmit 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 preventflea developmentfor [more than 10 weeks] up to [75 days)[2.5 months]] [Breaks Flea Life Cycle for [more than 10 weeks] upto [75 days][2.5 months] [Controls flea reinfestation for (more than 10 weeks] upto [75 days][2.5 months] [With [S-Methoprene] Insect Growth Regulator [IGR] to Break Flea Life Cycle[

1Applicator 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 automaticallyopens 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 yourdog
- notyour hands Directs the liquid onto yourdog
- awayfrom your hands Applies liquid to yourdog's skin
- not yours Helps prevent applying the wrong spot-on [doseJ [product] on [toJ the wrong pet Convenient, easyto use ACCU-TIP [ApplicatorJ [DISPENSER[ [Easyto 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 Foruse [only] with [brand name][Applicator] ([1][3][4[[6J monthlytreatments) [1][3J[4][6J Months Supply [24][48J doses Easyto use [convenientJ refills Applicator name options (applicator device is used in text) Applicator Tool Device Applicator Device Application Tool

2Thermoform 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 0.20fl oz (6.0 ee) Iviallllubej(eartridgej (Large Dogs) 0.30fl 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

## 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 awayfrom treated dogsfor 24 hours. 

### If applied or ingested, contact your 

### veterinarian immediately. [RF2164 NT COMBO] prevents flea eggs from developing into adult fleas [morethan 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 foryour dog. [brand] provides flea and tick protection for dogs for up to 30 wdays
- and protection from flea reinfestation beyond. That's because it doesn'tjust kill adult fleas and ticks, 

### it also prevents reinfestation by knocking out flea eggs and larvaethat could hatch later on. Plus, it kills and repels mosquitoes. A unique, convenient applicatorforyou
.... 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[foryour 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 hairto allow the liquid to more readily [better] reach [apply] the [to] [your dog's] skin. Thetube [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 otherflat surface, it won't run out or drip. DIRECTIONS FOR USE: It is a violation of Federal Law to usethis 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 afterthe initial application. Apply this product once every 30 days unless a retreatment is necessary. Do not make the retreatment soonerthan 8 days afterthe initial treatment. Do not retreat more 1han once**p~~** , month. RF2164 NT COMBO works by application directlyto the dog's skin, not to the hair. When applying, use applicator devicetipto push aside dog's hairto allow direct appl,;c&t;oll to the skin. Do not getthis product in dog's eyes or mouth. [(Note: Application nowassumes 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 disposeof liquid cartridges [tubes][vials]with less mess.

4[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 forflexibility in device manufacturing. Each set of DFU has the same 6 steps: Open, Load, Close, Apply, Dispose, Retreat If NecessaryUse Restrictions, so the minordifferences relate to devicefeatures. Potential icon designs are on the last pages ofthis document. Text appearing on icon pages isfor 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 applythe [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 shoulderto the base ofthe tail. At each spot, use the tip ofthe 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 ofthe solution at anyone spot that could cause some of the solution to run offthe side of the dog. Do not spread RF2164 

### Aff COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application over the entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] When finished, hold applicator device overtrash. Push side ]buttons together] to open applicator device door and discard empty cartridge ]tube][vial] into trash or offerfor recycling if available. [Close applicator device doorand 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 soonerthan 8 days afterthe 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 ofthe back from the shoulderto the base ofthe tail. At each spot, usethe tip ofthe applicator device to part the hair until the skin is visible. Then push 5

### 5 6 down on the round [circle][button[[thumb pad] to dispense a portion ofthe solution on the skin. Do not apply an excessive amount of the solution at anyone spot that could cause some ofthe 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 overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe 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 doorfacing 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 intothe 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 ofthe dog. Do not spread RF2164 

### AJT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help todistribute the material overthe skin. 5. DISPOSE [icon] Push side [buttons] to open doorand drop empty tube [vial][cartridge] into trash orofferfor 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!rthan 8 days afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains suffident cartridges/tubes/vials for [X] applications),

6FOR [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 orfive [evenly placed] spots between the shoulder andthe 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 ofthe dog. Do not spread RF2164 AIT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe 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 thattube [cartridge][vial] fits securely in the applicator.] 3. CLOSE [icon] Close the [color, e.g. green] doorand 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 dooronce at each of [two] (Toy dogs) [three[ (Small Dogs) (Medium dogs) evenly placed spots between the shoulderto the base of the tail. Do not apply an excessive amount of the solution at anyone spot that could cause some ofthe solution to run off the side of the dog. Do not spread RF2164 

### AfT COMBO by hand overthe dog. Although the dog's skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] To dispose of empty tube, open [color, e.g. green] door and drop empty tube !Ilto,tr?sh or off!3rfor recycling if available. [Close applicator device doorand 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 afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for 

### [Xl applications]

7FOR [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 orfive evenly placed spots between the shoulder to the base of the tail. Do not apply an excessive amount of the solution at any one spotthat could cause some of the solution to run off the side of the dog. Do not spread RF2164 

### AfT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment 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 orswimming.] 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 orofferfor recycling if available. If partiallyfilled: Call your local solid waste agencyfor disposal instructions. Never place unused product down any indoor or outdoordrain. 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.
8FIRSTAID 

### If in eyes 

## • Hold eyeopen and rinse slowly and gently with waterfor**15~20** minutes. 

## • Remove contact lenses, 

### if present, afterfirst 5 minutes, then continue rinsing 

## • Call a poison control center ordoctorfortreatment 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 consistentwith applicable law, Seller makes no otherwarranties, and disclaims all other warranties, express or implied, including but not limited to warranties of merchantability and fitness for the intended purpose. Tothe extent consistent with applicable law, seller's liability for default, breach, or failure underthis labelshall be limited to the amount of the purchase price. Tothe extent consistentwith applicable law, Sellershall have no liability for consequential damages. In case of emergency or for product information, call 1**~800·xxx~xxxx** orcontact 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 Onlyon 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[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 

### ifspace 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 applythe 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



### 10Alternate Sets of ICONS forthe RF2164 AfTCOMBO [ICON SET 1] [OPEN] [LOAD]

[CLOSE]

[APPLy]

[DISPOSE]

11[ICON SET 2] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size)



### twoside



### UP

Close1f1e

### greendoorand



### the tubewill

### snapopen. To APPLY UseTipto parttur and

### get nextto dOg'sskfn. Presscircle

### ongreen door

once

### ateach of# s!X)ts between shoUlders andtail

DISPOSEof""l'iytube PUGh

### tvvosidebuttonsto 

### opengreen doorand drop

("#Spots" is a variable dependent on size) Alternate LOAD icon

To LOADplacetubeWHITESide UP

### ~ooerthe

CLOSEthe greendoor and!hetubewill snap

### opert


### 1:1-[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific 10 dog's size) Use

### fingersooop

### to lit! OPENdoor

To LOADplace tube WHITE side UP**~rthegreentabs**

ToAPPLY UseTip

### topartfur



### , nexttodog's

### skin. 

### ongreendoor oncealeach01 # 

### spots between shoulders andtail

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



### 12 /3

## NOTREVIEWED InAc( lancewith

## PRNotice82.2 

## Based vd

## DraftLabeliMDated 

## RF2164 AIT 

# COMBO-
__**~-",,=-'l.L--,!~~II~** 

## __ [Textfor "Dog" mustbe samesize as Brand Name] Front Panel**~** For Use Only on Toy (6 R 12Ibs.), Small (13 R31 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 ofage orolder [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] yourdog Effective on indoor and outdoordogs ([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] ]FastActing]Long Lasting]KiIIs Fleas and Ticks by Contact] ] Fresh][CleanlOScent]Smell] ]Reapply monthly] [Suitable foryear-round use[Month] stickerfor 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 3to 4 weeks] [Protects for up to]Four/4] Weeks][One month][Four/4 Week]Flea][fick]Mosquito] Treatment] ]Aids in Control ofTicks for up to 30 days] ]Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hoursllKilis more than 50% offleas 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 (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]



### 1Applicator 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] getdown 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 dripwhen set down as you go fetch the [your] dog Includes unique [brand] applicator Puts the liquid on yourdog
- not your hands Directs the liquid onto yourdog
- not your hands Directs the liquid onto your dog
- away from your hands Applies liquid to yourdog's skin
- notyours Helps prevent applying the wrong spot-on [dose] [product] on [torthe wrong pet Convenient, easy to use ACCU-TIP [Applicator] [DISPENSER[ [Easy to use] Longerapplicator 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 Onefree month supply [dose] included Bonus pack Free [applicator][tube][vial[cartridge]][inside] Designed not to dripwhen set on top ofthe 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

### 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: 0.05fI 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

## 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 OTHERANIMALS!

[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 dogsfor up to 3D-days
- and protection from flea reinfestation beyond. That's because 

### it doesn'tjust kill adult fleas and ticks, 

### it also prevents reinfestation by knocking out flea eggs and larvae that could hatch lateron. Plus, 

### it kills and repels mosquitoes. 

### A unique, convenient applicator foryou
.... The new [brand] Applicator is specially designed to make applying flea and tick control easier, more precise
-- and neater
- than ever before. You simply insertthe 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 confidentthatthe liquid goes onto your dog
- and not your hand. Plus, ifthe applicator is laid down on atable, counteror otherflat surface, itwon't run out or drip. 

### DIRECTIONS FOR USE: It is a violation of Federal Lawto usethis 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 afterthe initial treatment. Do notretreat more than once per month. RF2164

### AfT COMBOworks by application directly to the dog's skin, notto 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] perdog per application)] The RF2164 

### AfT COMBO provides a unique applicatordevice that allows dog owners to treat theirdogs more securely, and dispose of liquid cartridges [tubes][vials]with less mess.



### 4[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 allowfor flexibility in device manufacturing. Each setofDFU hasthe same 6 

### steps: Open, Load, Close, 

### Apply, Dispose, Use Restrictions, sothe minor differences relate to devicefeatures. Potential icon designs are on the last pages ofthis document. Text appearing on icon pages is for illustrative purposes only and does not represent lulltextas 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 applicatordevice in one hand, push the side [buttons] to open the device. 2. LOAD [icon] Place one disposable liquid cartridge [vial][tube] in the applicatordevice, ensuring that the cartridge [vial][tube] fits securely in the slots inside the applicatordevice. 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 yourdog. 4. APPLY [icon] The dog should be standing for easy application. Apply RF2164 AfTCOMBO evenly to [two spots](toy dogs)[three spots](small dogs)(medium dogs) on the top ofthe back from the shoulderto the base ofthe tail. At each spot, use the tip ofthe applicatordevice 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 ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 AfT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] When finished, hold applicatordevice overtrash. Push side [buttons together] to open applicatordevice door and discard empty cartridge [tube][vial[ into trash or offer for recycling if available. [Close applicatordevice 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 morethan 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 ofthe back from the shoulderto the base of the tail. At each spot, use the tip ofthe applicator device to part the hair until the skin is visible. Then push 

### 5

### 5 6 down on the round [circie][button][thumb pad] to dispense a portion ofthe solution on the 

### skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run 

### allthe side ofthe dog. Do not spread RF2164 

### AIT COMBO by hand overthe dog. Although the dog's skin and hairoils will naturally distribute the 

### application overthe entire dog, brushing the dog 12-24 hours aftertreatment 

### will help to distribute the material overthe skin.

[DFU Set No.2) FOR [TOY][SMALL][MEDIUM] SIZE DOGS To applythe [RF2164 

### AIT COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

### [for each application] with the applicator device. 1. OPEN [icon] 

### With green 

### doorfacing downward, push side [buttons] to open applicator. 2. LOAD [icon] (3 alternate statements) -[To Load, inserttube [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 ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe 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 overthe entire dog, brushing the dog 12-24 hours after treatment will help to distribute the material overthe skin. 5. DISPOSE [icon] 

### Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offerfor 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 soonerthan 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]



### 6FOR [LARGE][EXTRA LARGE] DOGS 

### 1 2 3 4 APPLY [icon] The dog should be standing foreasy 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 offour orfive [evenly placed] spots between the shoulder and the base ofthe tail. Do not apply an 

### excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164

### NT COMBO by hand overthe dog. Although 

### the dog's skin and hair oils will 

### naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material over the skin. 

### 5 

### 6

... [DFU Set No.3] FOR [TOy][SMALL][MEDIUM]DOGS To applythe [RF2164

### NT COMBO] treatment, use one disposable liquid cartridge**[tube][via~** 

### [for each application] with the applicatordevice. 1. OPEN [icon] 

### Use finger scoop to lift 

### open door. 2. LOAD [icon] (2 alternate statements) -[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] 

### 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 shOUlderto the base ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run off the side ofthe dog. Do not spread RF2164

### NT COMBO by hand overthe dog. Although the dog's 

### skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog**12~24** 

### hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] 

### To dispose of empty tube, open [color, 

### e.g. green[ door and drop empty tube into trash or offerfor recycling if available. [Close applicatordevice door and store in original package.] 6. USE RESTRICTIONS 

### Do not reapply product for 30 days unless re-treatment is required, but not soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. ]Note: 

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



### 7FOR [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 nextto dog's skin. Press [circle] [[round] thumb pad] on green dooronce at each offour orfive evenly placed spots between the shoulderto the base ofthe tail. Do not apply an excessive amount ofthe solution at any one spotthat could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 

### AJr COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 

### S 

### 6

... 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 ofthese pests in conjunction with this treatment. Monthlytreatments are required for optimal control and prevention of fleas. [The successive feeding activity offleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs with RF2164

### AJr COMBO rapidly kills fleas and may reduce the incidence ofthis 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'C t 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: Ifempty: Do not reuse cartridge [vial[ [tube]. Place in trash or offerfor 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. Forexternal 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. Ifsigns 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 ortemporary 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

### FIRSTAID 

### If 

### in eyes 

## • Hold eye open and rinse slowly and gentlywith waterfor**15~20** 

### minutes. 

# • Remove contact lenses, 

### ifpresent, afterfirst 5 minutes, then continue rinsing 

## • Call a poison control centerordoctorfortreatment 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. WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conformsto the chemical specifications expressed on the label. To 

### the extent consistentwith applicable law, Selier makes no otherwarranties, and disclaims all other warranties, express orimplied, including but not limited towarranties of merchantability and fitness for the intended purpose. To the extent consistentwith appticable law, seller's liability for default, breach, or failure underthis label shall be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Seller shall have no liabilityfor consequential damages. In case of emergency orfor product information, call 1**~800~xxx-xxxx** 

### or contact your veterinarian ifyour 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 ofage orolder



### 9[SUB-LABEL FOR REFILL CARTRIDGES] [Product Name] [Flea & Tick [& Mosquito][Treatment] [and] Control] SpotROn Flea & Tick Controlfor Dogs ACTIVE INGREDIENTS: Etofenprox (CAS

### # 80844-07-1)

....................................................................30.0% S-Methoprene (CAS

### # 65733-16-6)

..................................................................3.6% Piperonyl Butoxide (CAS

### # 5t-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 inconsistentwith 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. Ifyou need directions for application, please call1-800-XXX-XXXX. (Precautionary and StoragelDisposal) text included) Wellmark International 1501 EastWoodfield Road 200W Schaumburg, Illinois 60173

10

### Alternate Sets of ICONS for the RF2164 AIT COMBO 

### [ICON SET 1) [OPEN) [LOAD)

[CLOSE)

[APPLy]

[DISPOSE)



### 11[ICON SET 2] ALTERNATE ICONS FOR DIRECTIONS FOR USE 

### (will be specificto dog's size)



### greendoorfacingdown 

### Push

### twosidebullooS



### To LOAD Placetubewith



### Closethegreendoer

### and



### the tube

### will

### snapopen ToAPPLY Usel1ptoparttur andgetnexttodog's

### skill Presscircleongreen door



### once ateachof# 

### spots betweenshoulders and

### tall

DISPOSE

### ofemptytube \:INO sidebuttonsto and



### ("#Spots" is a variable dependent on size) Alternate LOAD icon}

ToLOADplacetube WHITEskie UP

# ~

CLOSEthe green door and thetube will snap open.
12-[ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size)
sooop 10\illOPEN

### door

To LOADplacetubeWHITE_ UP**~r1hegreentabs**



### CLOSEHle

### greendoor and

### thetubewill To APPLY UseTiptopartfur 

### andgetnexttodog's

### skin.**~ ro~** 

### cirde ongreendoor



### onceateach of# 

### spots betweenshoulders 

### andlall

C'#Spots" is a variable dependent on size)



### 213

# RF2164 AlT COMBO [Textfor "Dog" must be same size as Brand Name] Front Panel M For Use Onlyon 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 ofage orolder [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & Tick Control for Dogs Genera! Claims: (Note thatclaims 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 indoorand 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 forcoat 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{stickerfor home calendar {Satisfaction guaranteed oryour 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 ofTicks for up to 30 days] [Starts Killing Fleas and Ticks within 15 minutes] [Kills 85% ofticks within 48 hoursf[Kills more than 50% offleas in 2 hours{ {Dual Action kills adult fleas and prevents flea development[ [Kills fleas, ticks, mosquitoes, flea eggs and flea larvae]]Dual protection (againstfleas and ticks){ Kills the Deer Tick, which maytransmit Lyme Disease Kills and Repels mosquitoes (the majorcarrier of canine heartworm-) Monthly application for most effective protection IGRClaims: ]Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea developmentfor [more than 10weeks{ up to]75 days[2.5 months[[ [Breaks Flea Life Cycle for{more than 10weeks] up to [75 days[2.5 months[ [Controls flea reinfestation for [more than 10 weeks] upto [75 daysf[2.5 months[ [With {S-Methoprene{ Insect Growth Regulator [IGR[to Break Flea Life Cycle[



### 1Appncator Claims [New] [applicator] [New] contemporary design ]brand name]]Applicator] helps to prevent getting liquid on ]your] hands ]brand name]]AppJicator] tip parts hairto help]JiquidllappJication] get down to [thellyour]]dog's] skin Ergonomically contoured [ergonomicIIshapeIIdesign] foreasy handling leaseof 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] doorautomaticaJly opens the]disposableIIliquid dispensing] tube

]viaillcartridge] ]brand name]]Applicator]]will not drip after opening] ]brand name]]Applicator]Won'tdripwhen 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 yourdog
- notyour hands Directs the liquid ontoyourdog
- awayfrom your hands Applies liquid to your dog's skin
- notyours Helps prevent applying the wrong spot-on Idose]]product] on Ito] the wrong pet Convenient, easyto useACCU-TIP [Applicator] [DISPENSER] ]Easyto use] Longerapplicatortip 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 dripwhen set on top ofthe counter, ortable, or otherflat surface, For usewith [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] monthlytreatments)]1 [3]]4]]6] Months Supply]24]]48] doses Easyto use [convenient] refills 

### Applicator name options (applicator device is used in text) Applicator Tool Device Applicator Device Application Tool

2Thermoform 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

## 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 ANIMALSI

[RF2164

### NT COMBO) prevents flea eggs from developing into adult fteas [more than 10 weeks) for upto [75 days)[2.5 months). RF2164

### NTCOMBO also kills fleas and ticks for3 weeks and kills and repels mosquitoes for3 to 4 weeks.J Effective flea & tick control foryour dog. [brandJ provides flea and tick protection fOf dogs for upto 3D-days
- and protection from flea reinfestation beyond. That's because 

### it doesn'tjust

### kW adult fleas and ticks, 

### it also prevents reinfestation by knocking out flea eggs and larvae that could hatch lateron. Plus, it kills and repels mosquitoes. A unique, convenient applicatorforyou
.... The new [brandJ Applicator is specially designed to make applying flea and 

### tick control eaSIer, more precise
-- and neater
- than ever before. You simply insertthe appropriate [brandJ tube [vialJ[cartridgeJ foryourdog 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 hairto 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, ifthe applicator is laid down on a table, counter or otherflat surface, it won't run out or drip, DIRECTIONS FOR USE: It is a violation of Federal Lawto 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 soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. RF2164 AfTCOMBO works by application directlyto the dog's skin, not to the hair. When applying, use applicator device tipto push aside dog's hairto 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 applicatordevice that allows dog owners to treat their dogs more securely, and dispose ofliquid cartridges [tubesJ[vialsJwith less mess.



### 4

### [Note: Each package contains sufficient cartridgesltubes/vJals for [X] applicationsJ [Note: This label contains alternate, independentsets of Directions For Use, which are providedto allowforflexibility in device manufacturing. Each set of DFU has the same 6 steps: Open, Load, Close, Apply, Dispose, Use Restrictions, so the minordifferences relate to devicefeatures. Potential icon designs are on the last pages ofthis 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 applythe [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 insidethe applicator device. 3. CLOSE [icon] Point the applicatordevice 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 ofthe back from the shoulderto the base ofthe tail. At each spot, use the tip ofthe 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 ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 AlTCOMBO by hand over the dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] When finished, hold applicator device over trash. Push s·rde [buttonstogether] to open applicatordevice door and discard empty cartridge [tube][vial] into trash or offerfor 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 afterthe init"ral treatment. Do not retreat morethan 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 foreasy application. Apply RF2154 AfT 

### COMBO evenly to four orfive spots on the top ofthe back from the shoulderto the base of the tail. At each spot, usethe tip of the applicator device to part the hair until the skin is visible. Then push 

### 5

### 5 

### 6 down on the round [circleJ[buttonJ[thumb padJ todispense a portion ofthe solution on the 

### skin. Do not apply an excessive amount ofthe solution at anyone spat that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164AfTCOMBO by 

### hand overthe dog. Although the dog's skin and hair oils 

### will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment 

### will help to distribute the material overthe skin.

[DFU Set No. 2J FOR [TOYJ[SMALLJ[MEDIUMJ SIZE DOGS To apply the [RF2164 AfTCOMBOJ treatment, use one disposable liquid cartridge [tubeJ[vialj 

### [for each application] with the applicatordevice. 1. OPEN [iconJ 

### With green doorfacing downward, push side [buttons] to open applicator. 2. LOAD [iconJ (3 alternate statements) 

### -[To 

### Load, insert tube [cartridge][vial] [colorside 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 ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side of the dog. Do not spread RF2164 

### AJT COMBO by hand overthe dog. Although the dog's skin and hair oils wiJ/ 

### naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [iconJ 

### Push side [buttons] to open door and drop empty tube [vial][cartridge] into trash or offerfor recycling 

### if available. [Close applicatordevice door and store in original package.] 6. USE RESTRICTIONS 

### Do not reapply product for 30 days unless re-treatment is required, but not soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]

6

### 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 offour Of

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

### excessive amount ofthe solution at anyone spot that CQuid cause some ofthe so/utlon to run offthe side ofthe 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 aftertreatment 

### will help to distribute the material overthe skin. 

### 5 6

... [DFU Set No.3] FOR [TOy][SMALL][MEDIUM)DOGS To applythe [RF2164

### AIr COMBO] treatment, use one disposable liquid cartridge [tube][vial] 

### [for each application] with the applicatordevice. 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 dooronce at each of [two] (Toy dogs) [three] (Small 

### Dogs) (Medium dogs) evenly placed spots between the shoulderto the base ofthe 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 ofthe 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 overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] 

### To dispose of empty tube, open [color, e.g. green] door and drop empty tube into trash or offerfor 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 soonerthan 8 days afterthe initial treatment. Do not retreat more than once per month. [Note: Each package contains sufficient cartridges/tubes/vials for [X] applications]



### 7FOR [LARGE][EXTRA LARGE] DOGS 

### 1 2

.. . 

### 3

... 4 APPLY [icon] The dog should be standing foreasy application. To apply, usetip to part hair and get next to dog's skin. Press [circle] [[roundJ thumb pad] on green door once at each offour orfive evenly placed spots between the shoulderto the base ofthe tail. Do not apply an excessive amount ofthe solution at any one spotthat CQuid cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 

### NT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distributethe application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material overthe 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

## Jproducts registered for residential area control ofthese pests in conjunction with this treatment. Monthlytreatments are required for optimal control and prevention offleas. [The successive feeding activity offleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs 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 awayfrom children and animals. Liquid Cartridge [viaIJ[tubeJ Disposal: Ifempty: Do not reuse cartridge [vialJ [tubeJ. Place in trash orofferfor recycling ifavailable. If partially filled: Call your local solid waste agency fordisposal instructions. Never place unused product down any indoor or outdoordrain. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANSAND 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 occurafterusing ANY pesticide product for pets. Ifsigns of sensitivity occur, bathe your pet with mild soap and rinse with large amounts ofwater. If signs continue, consult a veterinarian immediately. Some pets may experience hair loss ortemporary skin irritation at the application site, Ifsigns persist orbecome more severe, contact veterinarian immediately and report incident to company at 1-800-XXX-XXXX. 

### 8FIRSTAID 

### Ifin eyes 

## • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

# • Remove contact lenses, 

### ifpresent, afterfirst 5 minutes, then continue rinsing 

# • Call a poison control centerordoctorfortreatment advice. Have the product container orlabel 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. WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To 

### the extent consistentwith applicable law, Sellermakes no otherwarranties, and disclaims all other warranties, express or implied, including but not limited to warranties ofmerchantability and fitness for the intended purpose. To the extent consistent with applicable law, seller's liabilityfor default, breach, or failure underthis label shall 

### be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Sellershall have no liability for consequential damages. In case ofemergency orfor product information, call 1-800-xxx-xxxx or contact your veterinarian 

### ifyour 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 ofage orolder



### 9[SUB-LABEL FOR REFILL CARTRIDGES] [Product Name] [Flea & Tick [& Mosquito][Treatment] [and] Control] Spot-On Flea & TickControl 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 

### ifspace allows] DIRECTIONS FOR USE: 

### It is a violation of Federal Lawto use this product in a manner inconsistent with its labeling. Read and follow all directions and precautions on this product label. 

### To applythe RF2164 

### AfT COMBO treatment, use one disposable liquid cartridge 

### [tube][vial][foreach 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. Ifyou 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

### Alternate Sets of ICONS forthe RF2164 

### AfT COMBO [ICON 

### SET 1] [OPEN] [LOAD]

[CLOSE]

[APPL

## YJ

[DISPOSE]



### 11VCON SET 2)ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size)



### greendoorfacing Pushtwo

### side

### 1lu11oos

To LOAD Place

### tubewith

Closethegreen doorand

thetube

### wmsnapopen. ToAPPLYUsel1ptopartfur 

### and 

### getnexttodog's

### skin_ 

### Presscirde

### on green:door 

### once at

### eachofit 

### spots bet\¥eenshoulders and

### tal

DISPOSEof

### emptytube 

### 1vIoskJe buttons

### to greendoorand 

### drop

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

- UP

CLOSE1he green door and the lubewill snap open. 

# 1"-

### [ICON SET 3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specificto dog's size)


### Use

### lingersooop 10

### illOPENdoor

To LOAD placetubeWHITEside UP

# ~

CLOSEthe

### greendoor andthe tubewillsnapopen ToAPPLY UseTrp10parttur 

### and gel

### next10dog's

### skin.**,~r** ,__circle 00

### greendoor



### onceateachof# 

### spots between shoulders andtail



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

# Material to be added to an e-Jacket/Jacket Reg. No. 

# 2724-811 Description: New Registration 1. Placementwithinthe 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 contractorsthis material: X Newly stamped accepted label o Notification X NewCSF X Other: 

# Correspondence
3. Attach this coversheettothetop ofthe material orjacket. It must be well organized and clippedtogether, NOT STAPLED. Then givethe materialwith this coversheetto staffin the Information Services Center (Room S-4900). 

# Reviewer's Name: Kevin Sweeney Phone:**~3"",O"",5"----",5-",O-",6,,,,-3** 

# ____ 

# Division: --!.R..!-"D"-- __ Date:**~3~/1~4~/~20~1~1~** 

# __________________ __
Created March 14, 2011**~\i\Oosr",~** U.S. ENVIRONMENTAL PROTECTION EPARegiSlralionNo. Dalc ofIssuance: 

# • • AGENCY



# . ft

.**~** 

### U OfficeofPesticidePrograms 

### 2724-811 

## MAR -9 2011

## ~S!fZ~ Registration Division (7505P)



### - 

# \,**~...;** 1200 PennsylvaniaAve., N.W.

'%0)": ",<,0 Washington, D.C. 20460 "It**PRO""\"~** Term oflssuancc: 

### NOTICE OFPESTICIDE, Conditional Registration 0" Registration 

### Expires March 10,2013 

# o Reregistration (underthe Federal Insecticide, Fungicide, 

### Name ofPesticide Product: 

### RF2164 AIT COMBO and Rodenticide Act, as amended)
Name andAddress ofRegistrant (include ZIP Code): WellmarkInternational 1501 E. Woodfield Road Suite200W Schaumberg, Illinois 60173 Note: Changes inlabeling differingin substancefrom thatacceptedin connection with this registrationmustbe submitted to and accepted bytheRegistrationDivisionpriorto use ofthe label in commerce. In any correspondence onthis productalwaysrefer tothe aboveEPAregistrationnumber. Onthe basis ofinfonnation furnished bythe registrant, the above named pesticide is hereby registered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement orrecommendation ofthis productbythe Agency. In orderto protect health and the environment, theAdministrator, onhis motion, may at any time suspend orcancel the registration ofapesticide in accordance with theAct. The acceptance ofanyname in connectionwiththe registration ofaproduct underthis Act is nottobe construed as giving the registrant a right to exclusive use ofthe name orto its use ifit has been covered byothers. This product is conditionallyregistered in accordance with FIFRA sec. 3{c)(7)(a) provided that: I. Thisregistration is time-limited andexpires two years from the datethis productis first released for shipment.
Youmustprovidethe Agencywith a projectedrelease for shipmentdate within 30 days ofthe date ofthis Notice ofRegistration. The Agency

### will calculate the expiration date basedonthe projectedrelease for shipment date until an actual releasefor shipmentdate is provided in writing.
2. Only one confidential statement offormula (CSF) (basic) willbe filed for this product; no alternate formulation orminor formulation statements maybe submitted orapproved forthis product. 

### 3. The basic CSF dated November 19, 2010 is acceptable andbecomes the CSF ofrecord. The alternate formulation CSF

### #I dated November 19,2010 is notacceptable.
4. Makethe following changes to the label:

a. Change: "5 size categories provide tighter (smaller] weightrangesto improve [maintain][deliver]

### efficacy[p~rfonnance][fleaand tick][control][protection] and to help reducethe risk ofadverse

### reactions on [for] yourdog."to "5 size categoriesprovide [smaller] weightranges to improve [maintain][deliver] efficacy [performance][flea and tick][control][protection] on [for] your dog." b. Remove: "Starts working in 15 minutes [lasts up to30 days]."

c. Change: "[brand name] [applicator] creates a barrierto [help] preventgetting liquid on [your] hands." to "[brand name] [applicator]helps to prevent getting liquid onyour hands." d. Remove: "Innovativeflea and tick application system [applicator]".

e. Change: "Kills and repels mosquitoes (the majorcarnerofcanineheartworm disease)" to "Kills and repels mosquitoes (the majorcarrierofcanme heartworm)" f. 

### The claim "New [formula]" and otherclaims employingthe word 'New' may appear on productproduced for 6 months from the date offirst distribution only.
g. Revise the EPA Registration Numberto read: "EPA Registration No. 2724-811. h. Based on comments made in 

### the CompanionAnimal Safety DataEvaluation Report dated February 5, 2009: i. Change: 'USERESTRICTIONS' toread: "Applythis productonce every 30 days unless aretreatment is necessary. Do notmake the re-treatment soonerthan 8days afterthe initial treatment. Do notretreat more than oncepermonth." ii. Change the heading: 'Retreat ifNecessary' to 'Use Restrictions' on all labeling. iii. 

### Atthebottomofpage 4 change" 'Reapply ifNecessary' to 'Use Restrictions' i. 

### Include American units ofvolumetricmeasure on your label. This includes the volume ofthe vials, which are currently only expressed in milliliters. Add the equivalentAmerican liquid measure expressed in ounces (oz.).

5. You must submitenhanced incidentreports for this producton a quarterly basis beginning April 1 , 2011. Please flag any ConfidentialBusiness Information as such. Enhanced incidentreporting should be submittedto the ProductManager. Quarterly sales information should be submitted to the Registration Division (7505P), Insecticides Branch (ATTN: Richard Gebken). The following is a list ofinformation needed byEPAtobettercharacterizethese incidents: EPA Registration Number Productname (brand name) 

### Lot# Wherepurchased: internet, store, veterinarian Active Ingredient(s) Weightrange forproduct Date on whichincidentoccurred. (mmJdd/yyyy) Statein which the incidentoccurred. (standard 2 letter abbreviation) Registrant case 

### # Species: dog, cat, other (specity) Breed: (as reported by petowner)Age: months oryears Sex: M, F, orneutered Weight: pounds PrimaryRoute ofExposure: dennal, oral, otheranimal, inhalation, other BodySystem: neurological, dennatologicaI, GI, respiratory, ocular, other Major signs noted with separatecolumn for eachsign, using standard tenninology Time to Onset: (hours, days) Treatedby veterinarian: yes or no Firsttimeproduct used: yes or no Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Anyknownprecondition EPA SeverityCode: death, major, moderate, minor Outcome: died, recovered, still treated, unknown

6. Along with the enhanced incidentreporting, you must submitan analysis ofthe incidents seen, to include the following details: All incidents should bereported includingall minordermal and ocular irritationreports. Summary table for dogs showing numberofincidents ofeachseverity codefor eachroute ofexposure. Each incident should only be reported once. Ifone incidenthas several routes ofexposure, the order should be ocular> oral> dennal. In otherwords, an incident withboth oral and dennal exposure wouldbereported as oral exposure, and an incident withbothocularand oral exposure would be reported as ocular exposure. A similarswnmarytable for cats (misuse orsecondaryexposure) showingnumber of incidents ofeach severitycode for each route ofexposure. Summarytable for dogs and table for cats showingnumber ofincidents that are believed due to secondaryexposure (e.g.,**multi~pet**households). A summarytable for dogs showing numberofincidents for eachseveritycode for these age ranges: <3 months,**3~6** months,**6~9** months,**9~**12 months, 1yr, 2yr, 3 yr, 4 yr, 5yr, 6 yr, 7yr, 8yr, 9 yr, 10 yr, 11 yr, 12 yr, 13 yr, 14 yr, 15 yr, >15 yr. A summarytable showingthe numberofdogincidents for eachseveritycode for each pet weightrange onthe productlabel. A summarytable for dog weight showingnumberofincidents for eachproductweight range. This table should show number ofincidents in dogs weighingless than thatproduct weightrange, number ofincidents in dogs in lowerhalfofweightrange, number of incidentsin dogs in upperhalfofweightrange, and dogs weighingmore than the product weightrange. Table showingnumberofincidents for each dog breed. Table showing number ofincidents indogs for each clinical sign. Table showingnumberofincidents in dogs for each organ system. Report aggregate incidents,butdo notcombinemoderate and minor incidents.

### 7. You must submitand/or cite alldatarequired for registration ofyourproductunderFIFRA Section 3(c)(5) whentheAgencyrequires allregistrants ofsimilarproductsto submit such data, and submit acceptable responses required for reregistration ofyourproductunderFIFRAsection4. 8. The acutetoxicity profile for this productis as follows: Route ofExposure Acute oraltoxicity Acute dennal toxicity Acute inhalation toxicity Primary eye irritation Primary skin irritation Dennal sensitization ToxicityCategory IV IV IV III IV 

### Negative

A stamped copy ofthe label is includedfor your file. Two copies ofthe finished labeling must be submittedpriorto releasingtheproduct for shipment. Ifthese conditions are notcomplied with, the registration will be subjectto cancellationinaccordance with FIFRA sec. 6(e). Yourrelease for shipment ofthe productconstitutes acceptance oftheseconditions. IfEPA determines that future mitigation measures are necessary for allpet spot-ons, the Agency will informregistrants. Ifmitigationmeasures are necessary, EPA may take regulatory action. Ifyou have any questions concerningthis registration, please contactKevin Sweeneyat (703) 305-5063.

, 

## /

# Sigll";ir~fAPP,\\,g

# :da10 

# I**Ri.a,~\:..w'~** Pnj t Manage; (10) 

### Registration Division tsecticide Branch
EPAForm 8570>6 

### Date: 

## MAR 9 2011

# RF2164 AfT

# COMBO [Textfor "Dog" must be same size as Brand Name] Front Pane!
R For Use Only on Toy (6 R 12 Ibs.), Small (13 R31 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 orolder [Flea & Tick [& Mosquito][Treatment] [and] Control] SpotROn Flea & Tick Controlfor 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 ofadverse 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[ [FastActing][Long Lasting][Kilis Fleas and T'lcks by Contact] [Fresh[Clean[[ScentJlSmellJ [Reapply monthly] [Suitable for yeaHound use[Month] stickerfor home calendar [Satisfaction guaranteed oryour money back] [Patent Pending] Efficacy Claims: Each tube [cartridge][vial] [application] [kills fleas & ticks for 3 weeks] and [kills and repels mosquitoes for 3to 4 weeks] [Protects for upto [Four/4] Weeks][One month][Four/4 Week 1 Flea][Tick][Mosquito] Treatment] [Aids in Control ofTicks 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% ofticks within 48 hours][Kilis morethan 50% offleas 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 DeerTick, which may transmit Lyme Disease Kills and Repe!s mosquitoes (the major carrier of canine heartworm disease) Monthly application for mosteffective protection !GRC!aims: [Contains an Insect Growth Regulator (lGR) to kill flea eggs and preventflea developmentfor [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 RodentlctdeAct. as amended. for the peaUclde registered.J¥lder EPA**Re~** No. 

## 2/;;1.4--51;1

1App!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 hairto 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 usewith [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 doorautomatically opens the [disposable][liquid dispensing] tube

[vial[cartridgeJ Innovative flea and tick application system [applicatorJ [brand name[ [ApplicatorJ [will not dripafter 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
- notyour hands Directs the liquid onto your dog
- notyour hands Directs the liquid onto yourdog
- awayfrom your hands Applies liquid to your dog's skin
- notyours Helps prevent applying the wrong spot*on [doseJ [productJ on [toJ the wrong pet Convenient, easy to useACCU-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 notto dripwhen set on top ofthe counter, or table, or otherflat 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] monthlytreatments] [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

### 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

## 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 awayfrom treated dogs for 24 hours. Ifapplied or ingested, contactyour veterinarian immediately. [RF2164 AIT COMBO) prevents flea eggs from developing into adult fleas [more than 10 weeks) for upto [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 foryour dog. [brand} provides flea and tick protection fordogsfor upto 3D-days
- and protection from flea reinfestation beyond. That's because it doesn'tjust 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 foryou
.... 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 allowthe 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, ifthe applicator is laid down on a table, counteror otherflat surface, it won't run out or drip. DIRECTIONS FOR USE: It is a violation of Federal Lawto 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 forthis product is twice per month, and the second application must be made more than 8 days afterthe 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 allowdirect 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 theirdogs 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 allowforflexibility 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

### [DFU Set No.1] FOR [TOy][SMALL][MEDIUM] SIZE DOGS To applythe [RF2164 AlT COMBO] treatment, use one disposable liquid cartridge**[tube][via~[for**

### each application] with the applicatordevice. 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 applicatordevice 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 ofthe back from the shoulder to the base ofthe tail. At each spot, use the tip ofthe 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 ofthe solution on the skin. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2 t64AIT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog t2-24 hours aftertreatment will help to distribute the material overthe skin. 5. DISPOSE [icon] When finished, hold applicator device overtrash. Push side [buttons together] to open applicator device door and discard empty cartridgejtube][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 soonerthan 8 days afterthe 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 RF2t64AIT COMBO evenlyto four orfive spots on the top ofthe back from the shoulder to the base ofthe tail. At each spot, use the tip ofthe 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 ofthe solution to run offthe side ofthe dog. Do not spread RF2 t64AIT COMBO by hand overthe dog. Although the dog's skin and hairoils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material over the skin. 

### 5 

### 6 5[DFU Set No.2] FOR [TOY][SMALL][MEDIUM] SIZE DOGS To applythe [RF2164 AfT COMBO] treatment, use one disposable liquid cartridge [tube][vial] [for each application] with the applicatordevice. 1. OPEN [icon] With green doorfacing downward, push side [buttons] to open applicator. 2. LOAD [icon] (3 alternate statements) -[To Load, insert tube [cartridgeJ[viaIJ [colorside downJ[white side up]. Press down on tube [cartridge][vial][ until [two green] tabs click in place]. -[To Load, place tube[cartridgeJ[vial]underthe [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 hairand get nextto 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 ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164

### AlT COMBO by hand overthe 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 overthe skin. 5. DISPOSE [icon] Push side [buttons] to open door and drop emptytube [vial][cartridge] into trash or offerfor recycling if available. [Close applicatordevice door and store in original package.] 6. RETREAT IF NECESSARY Do not reapply product for 30 days unless re-treatment is required, but not soonerthan 8 days afterthe 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 offour orfive [evenly placed] spots between the shoulder and the base ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that could cause some of the solution to run off the side ofthe 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 overthe entire dog, brushing the dog 12-24 hours aftertreatment will help to distribute the material over the skin. 

### 5

... 

### 6
6[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] Usefinger scoop to 

### lift open door. 2. LOAD [icon] (2 alternate statements) -[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] 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 nextto 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 shoulderto the base ofthe tail. Do not apply an excessive amount ofthe solution at anyone spot that CQuid cause some ofthe solution to run off the side ofthe 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 overthe skin. 5. DISPOSE [icon] To dispose ofempty tube, open [color, e.g. green[ door and drop empty tube into trash or offerfor 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 soonerthan 8 days afterthe 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 shoulderto the base ofthe tail. Do not apply an excessive amount ofthe solution at any one spot that could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 AlT COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe entire dog, brushing the dog 12-24 hours after treatment will help to distribute the material over the skin. 

### 5

.. . 

### 6

...

7

### 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 ofthese pests in conjunction with this treatment. Monthly treatments are required for optimal control and prevention offleas. [The successive feeding activity offleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment of dogs with RF2t64

### NT COMBO rapidly kills fleas and may reduce the incidence ofthis condition.] [RF2 t64AIT COMBO iswater 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: Ifempty: Do not reuse cartridge [vial] [tube]. Place in trash oroffer for recycling if available. Ifpartiallyfilled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoordrain. 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 orclothing. 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 ofwater. If signs continue, consult a veterinarian immediately. Some pets may experience hair loss ortemporary 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. FIRSTAID If in eyes 

## • Hold eye open and rinse slowly and gently Vllith waterfor 15-20 minutes. 

## • Remove contact lenses, if present, afterfirst 5 minutes, then continue rinsing 

## • Call a poison control center ordoctorfortreatment 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.

8WARRANTYAND CONDITIONS OF SALE: Sellerwarrants that this product conforms to the chemical specifications expressed on the label. To the extent consistent with applicable law, Seller makes no otherwarranties, 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 underthis label shall be limited to the amount ofthe purchase price. To the extent consistent with applicable law, Seller shall have no liabilityfor consequential damages. In case of emergency orfor product information, call 1-800-xxx-xxxx or contact your veterinarian 

### jfyour 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 ofage orolder



### 9[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 applythe RF2164 AIT COMBO treatment, use one disposable liquid cartridge 

### [tube][vial][foreach application] with the applicatordevice, 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. Ifyou 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

### Alternate Sets of ICONS forthe RF2164 AlT COMBO [ICON SET 1] [OPEN] [LOAD]



# '" [CLOSE]

[APPLy]

[DISPOSE]

11[ICON SET 2) ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size)



### To LOAD 

### Place tubewith WI-lrrE side UP

### inte)applicator

# I

Close

### the green doorand



### the tube1/,1111

### snap open. ToAPPLY UseTIpto parttur 

### and getnext

### to dog's skin. Pressdrdeon green door



### once ateachof -# 

### spots between shoulders and

### tal!

DISPOSEofemptytube 

### two side buttonsto and tube



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

### (Alternate LOAD icon) To LOAD place tube WHITE skle UP

### ~erthe_:~7n tatB

# ·.~I! 

# / c::'

CLOSEthe green door and the tube will snapopen.


### 1

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

### Uselingerscoopto liftOPEN door



# I CLOSE

### ltle green door 

### and the tube

### WIllsnapopen.

onceat # spoIs between shoulders aMtail



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



### 2

### Wellmark 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 PetTopical Device 10/281201010:20AM

Kevin! Kimberly**~** Iwanted to touch base with you guysand offer HED'sthoughts on the new pet topical device that was presented to us by Wellmark. Allie Lamay and I tookthe topic to our Exposure SAC and we directed an open discussion regarding the device. The ExpoSAC concurred that there is not a need foran additional qualitative human health riskassessmentfor the currently registered product due to the proposed change. They agreed thatthe device does not reduce exposure potential forthe applicator; at a minimum it is equivalent to the current method and may have the potential to increase risk. Many thought that the newdevice could create a newexposure scenario because ofthe potential for ai to accumulate with each application, in effect, becoming a sinkfor 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 newdevicewould be qualitative and speculative at best. In sum, mostwho attended ExpoSAC viewed the device nota 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 howthe 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

### Re: Spot On Applicator Question 

### [j Wade Britton to: Kevin Sweeney 09/22f2010 10:45AM 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, SeniorEntom%gist

## u.s. Environmenta/l 

## I Originaletofenproxriskassessmentforpets was donebyJackArlhur.1 J i

### l~ Kevin Sweeney Wade Britton , Thanks Kevin. IlookedoverJack'sriskassessmentanditisapt

Thanks Kevin. I looked overJack's risk assessmentand 

### it is appropriate based upon current standards. So, no new RA required. Allie and Iwill directdiscussion ofthe new application device to the ESac and keep you guys posted on what comes outofthe mix. Wade Kevin Sweeney Odginai etofenprox riskassessment'for pfifswa
... From: To: Cc: Date: Subject: Kevin SweeneyfDCfUSEPAlUS Wade BrittonfDCfUSEPAlUS@EPA Kimberly NescifDCfUSEPAlUS@EPA 09f22J20

### to to:37 AM Re: Spot On Applicator Question 091221201010:37:44AM

Original etofenprox risk assessmentfor pets was done by JackArthur. You may wish to discusswith Jack, He did the onefor Pet Logic. I think it may have been used for Wellmark 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 HEDwould liketo know to what p
... 09/221201010:19:32AMFrom: To: Cc: History: I 

### Spot On ApplicatorQuestion 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 SpotOn Applicator Question 09/22/201010:19 AM

Kevin Sweeney I 2724-796Kevin J. Sweeney, SeniorEntomologist

## u.s. Environmental

# I
Kevin Sweeney Wade Britton Originaletofenproxriskassessmentforpets was donebyJackArthUr.J' Thanks Kevin. I lookedoverJack's riskassessmentandItIs**a~1**

Kevin
- We in HED would like to knowto what products (names, reg no., active) the new external applicatordevicewould apply, We intend to generate discussion within our Exposure ScienceAdvisory Council regarding howto assess risk from the applicator. On a separate note, we wanted to look back at the risk assessments conducted forthe registered productto which thiswould 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

### FW: September 

### 15 MeetingNotes JamesMcFadden 

### to: 

### Kevin Sweeney 10105/201001:04 PM Cc: Steve Spaulding ShowDetails

Kevin
- As far as Ican 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 ofSeptember 15, 2010 to discuss a new Applicator Concept. Attendees: EPA: Kevin Sweeney Wade Britton Alexandra LeMay Kit FalWell Richard Gebken Kimberly Nesci Byron Backus Wellmark International Steve Spaulding Steve LeVeau James McFadden

After introductions, Steve Leveau discussed findings ofWellmark's consumer research; documenting concerns consumers had about the use ofcurrent spot-on products. He then introduced the new applicator concept, and showed how it addressed many ofthe consumerconcerns. Key benefits were expressed thatthe 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- 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 ofthe applicator may need to be discussed (internally) to determine howto (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 ofthe 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 adesire 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 formulawas 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.

- EPAwas not clear about how the confirmation ofdelivery volume would be submitted. Ifsubmitted in a report, it would require assignment ofan MRID#, and the application would then likely be assigned to PRIA Category R310. Ifsubmitted as part ofthe 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 issueswould likely be handled (and whether HED review would be required).

- EPA agreed itwas 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 ifyou have comments or corrections to these notes and thank you again for your time and assistance. In addition, we would appreciate ifyou 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 forthe Recipient(s) named above. Ifyou are not !he in!ended Recipient, any use, dissemination, distribution or copying ofthe communication is strictly prohibited. If received in error, weapologize and askthatyou please notify the Sender by returning thise·mail and permanently deleting this communication from your computer, including destruction ofany printed copies. Any views expressed herein are not necessarily those ofthe Company represented bythis 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

# Wellmark"

January 3, 2011
R. Gebken, PM 13 Registration Division Document Processing Desk Office ofPesticide 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.

WellmarkInternalional



### Subject: Response to EPA E-MaiJ ofJanuary 3,2011, Cleanlabelsfor EPA New ProductApplication, EPA File SymhoI2724-IRR,RF2164

## Arr COMBO
DearMr. Gebken: Enclosed with this letterplease find printed labels as requested in E-mail from Kevin Sweeney on January 3, 2011. These labels support the RF2164 ArrCOMBO Application.

Please let me know ifyou have any questions orrequire further information regarding this application, and thank you for your assistance. '

Regards,

## ~~~7**~~?~...-/".;.;;~~~** James McFadden, Ph.D. Sr. Regulatory Project Manager

Page 1of I

### 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 submitteda revisedlabeldirectlyto the reviewerandit 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. kevinKevin 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> SubjectFW: 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-IRRRequired:

### Descriptio~l : Agenda: Kevin
- 

### Meetwith Wellmark on pettopical delivery device Calendar Entry Wed 0911512010 11'.00 AM

- 12:00 

### PM Rooms: RD Small Conference Room D (S-7771)/PotomacYard 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

Fortomorrow'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 Ithink we mentioned previously, the attendees from ourside are: Steve Spaulding, Director of RegulatoryAffairs Steve LeVeau, Sr. Marketing Manager, Companion Animal Health (And me). Thank you foryour assistance James McFadden Sr. Regulatory Project Manager Wellmark 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, whichwe 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.

### 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

# RF2164 

# AfT COMBO [Textfor "Dog" must besamesizeas Brand Name] Front Panel- ForUse Onlyon 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 Onlyon Dogs6 months ofageor o!derJ 

### [Flea &. 

### Tick [& 

### MosguitolJTreatmentJ [and] Contron 

### Spot-On Flea &. 

### TickControlfor Dogs General Claims: (Note that claims previously approved for RF2042 COSO, 2724-796, are in black text) 5 size categories providetighter fsma!!erlweight ranges

### to improve [maintainlfdeliverJ efficacy [performancel[flea andtickJrcontrolJ[protectionl andto help reducethe risk of adverse reactions on [for] yourdog Effective on indoorand outdoor dogs ([1][3][4][6] monthlytreatments) [1][3][4][6] Months Supply]24][48] doses Spreads naturallywith 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] ]FastActing][Long LastingTIKills Fleas and Ticks by Contact] [FreshllClean][[Scent][Smell] [Reapply monthly}]Suitable for year-round use][Month] stickerfor home calendar [Satisfaction guaranteed oryour money back] [Patent PendingJ EfficacyClaims: 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 upto 30 days] [Starts Killing Fleas and Ticks within t5 minutes] [Starts working in 15 minutes [lasts UPto 30days] [Kills 85%ofticks 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 maytransmit Lyme Disease Kills and Repels mosquitoes {t.b.§ major carrier of canine heartwormdisease) Monthlyapplication for mosteffective protection IGRClaims: {Contains an Insect Growth Regulator (IGR) to kill flea eggs and prevent flea development for [more than toweeks} up to [75 days]2.5 monthsll [Breaks Flea Life Cycle for]more than 10weeks} up to [75 days][2.5 months} ]Controls flea reinfestation for [more than 10weeks] upto [75 days][2.5 months] [With [S-Methoprene] Insect Growth Regulator [IGR} to Break Flea Life Cycle]

1Applicator Claims [New] [applicator] [NewJ contemoorarydesign [brand name] [Applicator] creates a barrierto [helP] prevent getting liquid on [yourJ hands [brand name) [Applicatorl tip parts hairto help fliquid][applicationJ get down to ftheJfyourlfdog'sJ skin Ergonomically contoured femonomiclfshapelfdesign] for easy handling [ease of use} [easy use] For usewith 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 doorautomatically opens the fdisposablelfliguid dispensing] tube

[viaOfcartridqe1 Innovativeflea andtick application system [applicator] [brand name] [Apolicator] [will not drip after opening] [brand name] [Applicator) Won't dripwhen set down as you gofetch the [your] dog Includes unique [brand] applicator Puts the liauid on yourdog
- notyour hands Directs the liquid ontoyourdog
- not your hands Directs the liquid onto yourdog
- awayfrom your hands Applies liquid to yourdog's skin
- not yOurs Helps prevent applving the wrong soot-on [dose] [productl on [to] the wrong pet Convenient, easyto use ACCU-TIP [Applicator] [DISPENSERl [Easy to use] Longer applicatortip 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 Onefree month suoply [dose] included Bonus pack Free [applicatorUtubeIfvialEcartridgeIlfinsidel Designed not to dripwhen set on top ofthe counter, or table, orother flat surface. For usewith [brand] applicator Applicator [device] notincluded [brand] Refill Pack fbrandlfapolicator [device] not included]



### Applicator name options (applicator device is used in text) Applicator Tool Device Apolicator Device Aoolication Tool

2

### Thermoform name options (tube. cartridge andvial 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

## RF2164 AfT COMBO IMPORTANT! DO NOT Use on Dogs LESS THAN 6 MonthsOLD 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 awayfromtreated dogsfor24 hours. Ifapplied or ingested. contactyour 

### veterinarian immediately. [RF2t64

### AfT COMBO] prevents flea eggs from developing into adultfleas [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 foryourdog. [brand] provides flea and tick protection for dogsfor UP to 30-days
- and protection from flea reinfestation beyond. That's because 

### itdoesn'tjust kill adultfleas and ticks. 

### it also prevents reinfestation 

### by knocking outflea eggs and larvae that could hatch later on. Plus. it kills and repels 

### mosquitoes. A unique. convenient applicatorforyou
.... 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 insertthe appropriate [brand] tube [vial][cartridgeJ for yourdog intothe 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 helpsto spread [part1 the [Your] dog's hairto 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 confidentthatthe liquid ooes onto your dog and notyour hand. Plus, if the applicator is laid down on a table. counter orotherflat 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 inconsistentwith 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, notto the hair. When applying, use applicator device tip to push aside dog's hair to allow directapplication to the skin. Do not getthis product in dog's eyes or mouth. [(Note: Application now assumes onetube[vialJ[cartridqe] perQQR.per application)] The RF2164 

### AfT COMBOprovides a unique applicatordevice thatallows dog O\'vners to treat theirdogs more securely, and dispose of liquid cartridges ftubesJ[vials]with less mess. [Note: Each package contains sufficientcartridges/tubeslvials for [X] applications] [Note: This label contains alternate, independent sets of Directions For Use. which are provided to allowfor flexibility in device manufacturing. Each set of DFU hasthe 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 isfor illustrative purposes onlyand does not represent full textas indicated in DFU which will appear on label.] 41. 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 thatthe cartridge [via!][tubeJ fits securely in the slots insidethe applicatordevice. 3. CLOSE [icon] Point the applicator device tip upward and closethe lid. The disposable [liquid1 cartridge [via!][tubel 

### wi!! automatically be clipped open and is now ready to be applied to yourdog. 4. APPLY [icon] The dog should be standing for easyapplication. Apply RF2164 

### Aff COMBO evenlyto [two spots](toy dogs}[three spots](sma!! dogs)(medium dogs) on the top ofthe back from the 

### shoulderto the base of the tail. Ateach spot. use the tiD of the applicatordevice to part the hairuntil the skin isvisible. Then push down on the round rcircleJrbutton][thumb padl to dispense a portion of the solution on the skin. 

### Do notapplyan excessive amount ofthe solution at anyone spot that could cause some of the solution to run off the sideofthe dog. Do not spread RF2164 AIT COMBO by hand overthe 

### doo. Although the dog's skin and hair oils wil! naturally distribute the application over the entire dog. brushing the dog 12-24 hours aftertreatment

### wi!! he!p to distribute the material over the skin. 5. DISPOSE [icon] When finished, hold applicatordevice overtrash. Push side [buttons together] to open applicator device door and discard empty cartlidge ftubeJ[via!J into trash orofferfor recycling if available. [Close applicator device door and store [applicatordevice] in origina! package.] 6. RETREAT!F NECESSARY. Do not reapply product for 30 days unless re-treatment is required, but not soonerthan 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 RF2164AIT COMBO evenlyto four orfive spots on the top of the backfrom the shou!der tothe base ofthe tail. At each spot. use the tip of the applicator device to partthe hair until the skin is visib!e. Then push down on the round [circ!elfbuttonJrthumb pad] to disoense a portion of the solution onthe skin. Do not app!van excessive amountof thesolution atanyone spot that could cause some of the solution to run offthe side of the dog. Do not spread RF2164 

### Aff COMBO by hand overthe 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

### -[DFU Set 

### NO.2]

1. OPEN [icon] With green 

### doorfacing downward. push side [buttons] to open applicator. 2. LOAD [icon] (3 alternate statements) -[To Load. inserttube 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 hairand get next to dog's skin. [Press circle on green door] [Press round thumb pad] once at each offtwo] (Toydogs) [three] (Small Dogs){Medium dogs) evenly placed spots between the shoulder and the base of the tail. Do not apply an excessive amount ofthe solution at anyone spotthat could cause some ofthe solution to run offthe side ofthe dog. Do not spread RF2164 

### Nf COMBO by hand overthe dog. Although the dog's skin and hair oils will naturally distribute the application overthe 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 emptytube fvialJ[cartridge] into trash or offer for recycling if available. [Close applicator device doorand store in original package.] 6. RETREAT IF NECESSARY Do not reapply productfor 30 days unless re-treatment is reqUired. but not soonerthan 8 days afterthe 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 orfive [evenly placed] spots between the shoulder and the base of the tail. Do notapply an excessive amount of the solution at anyone spotthat could cause some of the solution to run offthe side ofthe dog. Do notspread RF2164 

### Nf COMBO by hand over the dog. Although the dog's skin and hair oils will 

### naturally distribute the application overthe entire dog. brushing the dog 12-24 hours aftertreatment will help to distribute the material over the skin.**5~ 6~**  6

### Ii 1. OPEN [icon] Use finger scoop to lift 

### open door. 2. LOAD (icon] (2 alternate statements)**~[To** 

### Load, place tube [cartridgelfviallunderthe [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 nextto dog's skin. Press [circle] [[roundl thumb padl on green door once at each offour 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 offthe 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 overthe skin.**~** 

### !L.=

7

### 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 offleas. [The successive feeding activity of fleas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD). Treatment ofdogs 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: 1rcartridael 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 awayfrom children and animals. Liquid Cartridge [vial]ftubeJ Disposal: If empty: Do not reuse cartridge (vial] [tube]. Place in trash or offerfor recycling if available. If partiallyfilled: Call your local solid waste agencyfor 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. Consulta 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 ofwater. 

### If signs continue, consult a veterinarian immediately. Some pets may experience hair loss or temporary skin irritation atthe application site. Ifsigns persist or become moresevere. contact veterinarian immediatelvand report incident to companyat 1-800-XXX-XXXX. FIRSTAID If-in eyes 

## • Hold eye open and rinse slowly and gentlywith waterfor 15-20 minutes. 

## • Remove contact lenses, 

### if present, afterfirst 5 minutes, then continue rinsing 

## • Calla poison control center or doctorfor treatment advice. Have the product container or label with you when calling a pO'lson control center ordoctor or going for treatment. You may also contact 1-800-XXX-XXXX for emergency medical treatment information.

8WARRANTY 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 liabilityfor 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 liabilityfor consequential damages. In case of emergency or for product information, call 1M800 Mxxx-xxxx or contact your veterinarian 

### ifyour 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 onToy (6-12Ibs.1. Small (13-31 Ibs.). Medium**(32~55Ibs.).** large (56**~80** Ibs'>, and Extra large(81 Ibs. and over) Dogs6 months ofageorolder

9

### Alternate Sets of ICONS for the 

### RF2164 AfT 

### COMBO [ICON SET 1] [OPEN]

# ~

[LOAD]

[CLOSE]

[APPLY]

[DISPOSE]

11[ICON 

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



### TOAPPLY

### Use1""'1'10

## !>"11m" an<!

### gel

### """10dIog'1s

__

_ cildleoogmen

### obr 0R:eate:adlofbE spo6 

# -- an<!laI

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

### Alternate LOAD icon

1

### [ICON SET3] ALTERNATE ICONS FOR DIRECTIONS FOR USE (will be specific to dog's size)

Tof4PFiLVUseTipIDpa1fur 

### _getnex!IDOOg's
__ l!' 

## "lJ<lIIS

## -~ _tail

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

2Tracking Create Resubmission FFS Letters

Action Code History

# 21-DayScreen Completedby Contractor 

# 21-DayExpires on _-,-I_L_-_I-,-<l_-_/=o_



# Jacket# 

# z 7 

# '2[/- 1P.r2.. 

# MRID#**~** 

# ContentScreen: ed to P « 

# f7 J/E,.,,,,/ 

# 6-5Review: A 

# TransferThis Jacketto:

I

## PRIA 2

- 21 DayContentScreenReview Worksheet (EPA/OPPUse Only) 3123/09 

### 21 DayScreen StartDate:

___**~/uIL------,,273,,---,--I-=O,---**

### ____ c:- 

### Experts In-Processing Signature: "",F IfA'Vt.NV6'OAl 

### Date //- Z. 

### 9-/ 0 

### FeePaid:

# 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 ItemsforReview Application Form (EPAForm 8570-1)(link to form) signed & 

### complete includingpackagetype
Confidential StatementofFormula all boxes completed, fonu signed, and a) All inerts (link to

### http://www.epa.gov!opprdOOllincrtsl), including fragrances, approved for the proposed uses (see FootnoteA) 

### yes Yes No 

### N/A*

no



### Certification with Respectto Citation ofData (EPAForm 8570-34) (Link to \r 

### form) completed and signed (N/A 

### if 100% repack) /\ Certificate and data matrix consistent Ifapplicant is relying on data that are compensable, is the offer to pay statement included. (see Footnote B)
If is there a letter ofAuthorization for exclusive use yes



### (EPA Form (Link to form) 

# x

no



### 4 completed and signed (N/A 

### ifsource is unregistered or applicant owns the

5 DataMatrix (EPA Fonn**8570~35)** 

### (Link to form) bothinternal 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 categoryexperts use) c) Applicant owns all data (Fee category experts use)


### 5 Copies ofLabel (link to http://www.epa.gov/oppfeadlllabeling/lrmi) 6 (Electroniclabels on CDareencouraged and guidanceis available)( link to 

# X http://www.epa.gov/pesticideslregulating/registering/submissions/index.htm#Iabels



### I

### 7 

### Isthedatapackageconsistentwith PRNotice 86-5 (link to PRN 86-5) 

# X

Notice ofFiling (link to 

### 8 

### httQ:/Iwww.eI,!3.gov/Qesticides/reguiatin2/tolerance Qetitions.htm) included 

# 'X- withpetitions (link to http://www.epa.gov/pesticides/reguiating/tolerances.htm) 

### 9 

### Ifapplicablefor conventional applications,reduced risk rationale (link to 

# X http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) RequiredData(linkto httl!:/ 

### /www.eQ3.gov/l!esticidesLregulatinI!Idata 

### reguirements.htm) and/or datawaivers. See Footnote C.

a) 

### List study (or studies) notincluded 

### with application



## 10

2

### Comments:

## IL~!%,' 

## \ 

# /g D !Vo 

### (>t\Adces 

## c,s.st>c(Cc'ied 

# w!jetciLet 1.lner+- '\f!c\Ced.{,CA-t 

# on 0!-{e.rr;4-t..::::... _(IOCML{lq

## unrCCD~,fiize) 1rc-.Je-

## nuflA~**~ ~,** 

( 1f1 

### 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. 

### Duringthe 21 day initial contentreview, all CSFs will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan unapproved inert is identified, the applicant must either 1) 

### resolve the inert issueby, 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 ofthe inert or 3) withdraw the application. Removing or substituting an inert ingredient will require a new CSF and mayrequire submission ofdata. All information, fonTIs, data and documentation resolving the inertissue musthave 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 ofthe 21 day initial content screen, applicants are stronglyencouragedto verify that all inert ingredients have been approved for the application's uses even if

### a productis currentlyregistered byconsultingthe inert Web 3

### site [link to http://www.epa.f!:ov/opprdOO]/inerts/lists.html] and ifthe inert is not approved, to obtain the necessaryinertapproval priorto submittingan application to register a pesticideproduct containingthatinertingredient. Someinert ingredients are no longer approved for food uses orcertain types ofuses. The name and/or CAS number on a CSFmust match the name and CAS number on this web site. Simpletypographical errors in the name or CAS number have resulted in processing delays. If

### an inert is notlisted on the ineltingredient web site and the applicant believes that the inelthas been approved, the applicant should contact the hlert Ingredient Assessment Branch (IIAB) at inertsbranch@epa.f!:ov andresolve the issue. Copies ofthe correspondence with llAB resolving the issue should accompany the application. All new inerts except PIP inerts arereviewed by IIAB. TheIIAB should also be contacted for any questions on what supporting data needs to be submittedfor and the Agency's inertreview process. Questions onPIP inerts shouldbe directed to the Chiefof Microbial Pesticides Branch [Link to http://www.cpa.gov/oppbppdI/biopesticides/contactsbprd.htm] . When a brand, trade, or proprietary name ofan inertingredient is listed on a CSF, additional information such as an alternate name ofthe 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 detennineifit has been approved. Each component ofan inert mixture (including a fragrance) must be identified. In

### some cases, the supplierofthe mixture or fragrance may need to

### provide this information to the Agency. Prior to the Agency's receipt ofan application, applicants mllst arrange with a proprietary mixture or fragrance supplier to providethe componentinformation to the Agency or promptly upon EPA'srequest. Ifthe inertingredients in a proprietaryblend (including fragrances) cannot or are not identified or provided within the 21-day contentreview period, the Agency will reject the application. During the 21 day contentreview, applicants should submit information to the individual identifiedby the Agency when the applicant is informed ofan unapproved inert. Unapproved Inerts Identifiedon 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 applicationby, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing theunapproved inert from the CSFor replacing it with one that is approved for the application'suses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate the inertreview/approval process;
4

### 3. Withdraw the application (the Agencyretains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedby the applicant within the 21 day contentreview period, the Agency will reject the application and retain 25% ofthe full fee ofthe categoryidentified. Conventional New Product Applications When the Registration Division identifies an unapproved inert on a CSFwith an application for a new productthat the applicant has not identified as requiring an inert approval (R311, R312 orR313), it will contact the applicant with the following options: 1. Correctthe application by, for instance, correctingthe inert's identity orCAS number, providing documentationthat 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. Submitthe infonnation and data needed for the Agency to approve the unapproved inert, including any required petition to establish oramend a tolerance orexemptionfrom a tolerance. (This option may change the PRIA category forthe application, which couldrequire a longer decision review time and a largerfee. Ifadditional 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% ofthe full fee for the fee category estimated); or

Ifnone ofthe 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 forthe new product-inert approval category. PIP Applications When the Biopesticide and PollutionPreventionDivision identifies an unapproved inert on aPIP CSF and a request to approve the inert does not accompanythe application, it will contactthe applicant with thefollowing options: 1. Correctthe application by, forinstance, correcting the spelling orname ofthe 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 mustbereceived bythe Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe forboth actions. 5

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented during the 21 day contentreview period, theAgency will reject the application and retain 25% of the fee.

B. A policy ondocumentation ofoffers to payis stillbeing developed, however, for a me-too orfast track (similarlidentical) new product, R300 orA530, an application without the necessary authorizations ofoffers to pay will be placed into eitherR30 1or 

### A531. TheAgency recommends that authorizations ofoffers to paybe submitted with otherPRIA applications to avoid delays in the Agency's decision. C. 

### Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submittingtheir application to the Agency. Documentation ofsuch discussions shouldbesubmitted with the study waiver.



### 6

### RE: RF2164 AfTCOMBO (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 ClausenEnvironmental 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 communicationUNITED STATES ENVIRONMENTAL PROTE<.;TION AGENCY WASHINGTON, D.C. 20460



### November 26, 2010

OPPDecision Number: D-442499 EPAFile Symbol orRegistrationNumber: 2724-IRR ProductName: RF2164 AIT COMBO EPAReceipt Date: 23-Nov-201O EPACompanyNumber: 2724 CompanyName: WELLMARKINTERNATIONAL JAMES MCFADDEN, PH.D. WELLMARKINTERNATIONAL 1501 E. WOODFIELDROAD, SUITE 200 WEST SCHAUMBURG,IL 60173 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration Application Subjectto Registration Service Fee 

### DearRegistrant: The Office ofPesticideProgramshas receivedyour application and certification of payment. If

### you submitteddatawith this application, the results oftbePRN-86-5 screenwill be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has determinedthatthis Actionis subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. TheActionhasbeen identified as ActionCode: R300
NEWPRODUCT;ME-TOO PRODUCTFASTTRACK;
No additional paymentis due atthis time. 

### Ifyouhave any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerel

# ~**ro~mg:** 

### aff

- 

# Z

chn ogy & 

### Resources ManagementDivision

# 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)L C 

### _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\ "

## R300 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 Bmust be submitted
- Group A and Bcan not be cited. Dafa Guideline 

### Group A: Product Chemistry Data sUbmitted 

### No. SfudyTille Yes No 830.1550 Product Identity & 

### Composition 

# X Description of materials used to produce the 830.1600 product " .' 

### 830.1650 Description offormulation 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. studyTifle 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

## R300 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 datato be used forthe 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 EfficacyTesting ofTermite 

# i 810.3800 i 

### Baits



### 2 

## ,Print letter Enter More Information Tracking

# FEEFOR SERVICEINVOICE 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

# # '\

# Wellmark" James McFadden', Ptr.Et

Wellmark International

November 19,20I0 

### Richard Gebken, PM13 Registration Division, RD DocumentProcessing Desk (REGFEE) Office ofPesticide Programs (7505P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington V A 22202


### Subject: Submission ofNew ProductApplication Containing (S)-Methoprene, Ethofenprox and PBO; Product Name: RF2164 Aff COMBO, 2724-XXX 

### (Contains Confidential Business Information)

Dear Mr. Gebken: Enclosed with this coverletterplease find our application for a new productcontaining 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 applicatordevice, 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 ourexistingproduct registration (2724-796) we are submitting th;s'

.. application under PRIA Category R300, with A PRIA fee ofS1434. (CheckcOJj'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 of8i\<." Product Application, Etofenprox 

### Wellmark 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 datacitation 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 ofFormula, (Basic and I alternate, 2 copies) Form 8570-27, Formulator's Exemption Statement, I copy Form 8570-34 Certification with Respect to Citations ofData Form 8570-35 DataMatrix for the RF2164 ArfCOMBO The following paragraphs provide additional description of: I. A list of(previously reviewed) snldies sllpporting this application and II. The benefits ofthe applicatordevice combined with ourethofenprox-based topical formula III. Discussion ofthe potential exposure issues associated with the applicator device. IV. Briefcomments on the draft label 

### 1. 

### StudiesSupportingtheApplication 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: ProductChemistry: 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, 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 scapularis 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 ofthese reports is cited 

### in the enclosed DataMatrix form, and each study is owned by Wellmark International.
Page 3 of8h ,ProdUCi Application, Etofenprox 

### II. Benefits oftheApplicatorDevice Used with OurEthofenproxFormula As discussed in ourSept. 15**Pre~Submission** 

### meeting with theEPA, Wellmark believes that the combination ofthis unique applicator and our**ethofenprox~based** 

### dogtopical formula offer significant benefits to the consumer: I. The Applicator Device

- the new device provides the consumerwith 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 applicatordevice will reinforce label language and reduce**mis~** 

### application to cats, which is a majorconcern for EPA. The ApplicatorDevice also allows consumers to make a**one~handed** 

### application ofthe product to their pets, resulting in an easierapplication for the consumer (not needing a third hand to hold thedog while they use two hands to apply the product). 2. The**ethofenprox~based** 

### fonnula. The relative safety ofourethofenprox 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 producthas a significantly lower total rate of 

### incidents. Even considering the lower sales of the ethofenprox product, the numberof incidents with cats for lhe ethofenprox product is significantly reduced. People who buy the ethofenprox product aren't smarter

- this product isjust much, much saferfor cats. Finally, the data also shows that the percentage ofincidents 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 ofthese points addresses a specific issuethat was raisedby the EPA in their Evaluation ofPet**Spot~OIl** 

### Products. And although the EPA has so far refused to allowus to document these benefits to the consumer in any way ontheproduct label, Wellmark believes thatthe data shows this product (dog topical and active ingredient) demonstrate significant benefits for the consumer and their pets. Therefore,**fast~track** 

### approval ofthe registration with the device would benefit both the consumerand theirpets. Wellmark would also like to pointout that in ouroriginal submission letter for the RF2042 CDSO product (now EPA Reg. No.**2724~796),** 

### we had noted that:

.......this new product should also providereduced risk to applicators andchildren. Ethofenprox has acute mammalian toxicity ofcategory IV and is classified as "not likely" to be a human carcinogen I. 

### SincePermethrin has an acute oral toxicity classification in Category III and is classifiedas a likely human carcinogen, an ethofenprox topical productfordogs will also provide reduced risk to applicators and children. This product is expected to be significantly saferthan some ofthe existing permethrin dog topical products, and so it will provide significant benefits to consumers. Although a reduced risk classification is notpossible since this product does not represent a new use, Wellmark believes the productdoes 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 catdeaths 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 dogtopical product will be much saferthan existingpermethrin dog topical products.

I See Federal Register NOlice for EPA'sFQPA Rationale for Ethofenprox and subsequent revisions 

### Page4 of81\, 

### 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 of2008 about the safety ofthis 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 productfor the consumer. 

### III.

### Discussion ofthepotential exposure issues associated with theApplicatorDevice. The application for the RF2164ATCOMBO 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 exposureand the exposureto dogs that need to be addressed by the EPA in the review ofthis application. The following paragraphs provide Wellmark's position onthese issues for considerationby the EPA. (Although HED indicated in our meeting that they didn't think the risk was higher than for the existing product.) 

### PotentialHumanExposure Issues Overall, thepotential human (adult and child) exposure associated with the RF2164 Applicator Device is considered by Wellmark to be similarto (and certainly not greaterthan) the potential exposure from the use ofthe existingethofenproxdogtopical, EPA Reg. No. 2724-796. Forapplicators, the only relevant route ofpotentialexposureduring 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 thedermal route is not ofconcern. The vaporpressure of all ofthe 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 ofthe RF2164 ApplicatorDevice minimizes dermal exposure during application by: • Placement ofthe applicatorcartridge in the RF2164 ApplicatorDevice is done with the unopened cartridge, so there is potentially no exposure priorto 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 applicatorto manually clip open the fluid cartridge with a scissors. Since the manual handling does have some potential for dermalexposure, the proposed RF2164 Applicator Device may reduce this potential. • During treatment ofthedog with the RF2164 solution, the RF2164 ApplicatorDeviceprovides some shielding ofthe applicator's hand (compared to the current device), so potential exposure should be reduced2

. 

### In addition, the application itselfis changed from a two-handed application to aone-hand application, which again could reduce the potential for dermal exposure. • Aftertreatment is complete, the disposable cartridge is designed to be securely disposed ofin trash without additional hand contact, so there is no potential for dermal exposure associated with the disposal step. • After disposal ofthe fluid cartridge, the RF2164 Applicator Device is intended (per label instructions) to be stored in the plastic clamshell until next use, so the provision ofa storage containerreduces accidentalexpOSure between applications.

2 

### Note that ourethnography studies have shown this is an issue with Frontline® customers. Page50fSl'i

..... Product Application, Etofenprox • There could be minimal potential exposure from handlingthe applicator device duringreuse. Again, the only relevant route ofexposure would be dermal. The only expected exposure for a child would be from contact with the pet post-application. Sincethe application rate ofthe RF2146 product is the sameas the cUiTentiy registered product (EPA Reg. No. 2724-796), both individual and aggregate risk assessments for otherspot-on productscoverthis new product. This is also the case for post-application adult exposure and risk. Considering these pointstogether, it seems clearthat potential human exposure associated with the RF2164 Applicator Device is eitherthe same or lowerthan 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 whetherthere was any potential for pesticide residue to accumulate on or contaminate the RF2164 Applicator Device. Wellmarksuggests that it would be expected that small amounts ofthe formulation may adhereto the outside ofthe applicatorfrom the application process. However, undernormal use these potential residues might be relatively constant as the applicator is usedto partthe hair ofthe animal and both removing and depositingthe formulation on the application device. Regarding human exposure, the exposure would be dermal and therefore ofminimal concern. Regarding pet exposure, ifthe applicatoris holding the device overthe dog at the time the cartridge breaks, the worsecase exposuretothe dogwould beapplication ofa single dose to one spoton the skin. Ifthe applicatordecidesto take another cartridge and treatthe animal, the exposure would be 2Xthe intendeddose. The companion animal safety study for adult dogs (6 month and older) was done at up to 5Xthe 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. PotentialPetExposure Issues The issues around petexposure are related to the amount ofthe actual dose and potential residues remaining in the cartridge or on the ApplicatorDevice after application. For example, ifpesticide residues were transferred tothe ApplicatorDevice during application, wouldthose residues beavailable to pets atthe next application and could they represent an overdose? Wellmark's response tothese issues suggests that: 1. Since the efficacy for the RF2l64treatment is dependent upon duplication ofthe delivery volume for the existing product (EPA Reg. No. 2724-796), it would initially seem importantto have data verifying that delivery volume for the new product was the same as the existing product. However, instead ofdelivery volume being a function ofmanufacturing that needs confirmation, that volume is specifically controlled by manufacturingto deliverthe appropriate (required) amount. SinceWellmark manufacturing will confirmthe cartridge fill volume prior to actual production, (and does so for every change in cartridge shape), it is not necessary to provide verification ofdelivery volume priorto sUbmission3• To provide more backgroundon control ofdelivery volume within a manufacturing environment, the following text explains how Wellmark controls delivery volume for existing packaging.
) It should be noted that this change in cartridge/tube shape is similar in execution to a numberofprevious changcs in shape or volume that have been executed by Wellmark. In none ofthese cases did EPA require contirmatory data on delivery volume, and so we don'tbelieve it is necessary to provide data for this new product submission. Page60f8**l'\~** < ProdUCI Applicalion, Elofenprox



### 2. In order to examine potential risks to pets, it is useful to considerthe potential likelihood of overdosing a dog with dog topicals using the new RF2164 ApplicatorDevice. Butbased 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 ifthey were to represent as much as 5% or 10% ofthe application, would not represent a safety hazard to the pets to which a treatment was being applied.

- In addition. the incidencedatadiscussed above for tlte existing product shows it to have an excellentrecord, with a significantly lower rate ofincidents and an improved incident profile. So on both ofthese issues (human and pet) related to potential exposure associated with use ofthe dog topical, Wellmark believes that:

- potential exposureto applicators is small and only via adermal route. Since ethofeprox has no dermal endpoint, exposure via the dermal route is not ofconcern. Page7 of 8**l\~** _. Product Application, ElOfcnprox



### - potential exposure to pets would be well within the margin ofsafety established in companion animal safety studies, so pet exposure is not ofconcern. 

### IV. BriefComments on the label A few briefcomments on the label are added to aid the reviewer:

- Text already approved by the EPA (forefficacy claims or precautionary statements) is shown in black in the label, added text specific to this product is in color.

- The efficacyclaims flow directly from the existing product (2724-796), but the directions for use are necessarily different.

- Two different (independent) sets ofDFU are included

- we would like to consider both.

- As far as we understand, additional label modifications required by Pet SpotOn mitigation requirements are addressed in the label text. 

### V.Summary In summary, this cover letter has provided: I. 

### A listof(previously reviewed) studies suppolting this application and II. A discussion ofthe benefits ofthe applicatordevice combined with ourethofenprox-based topical formula, and the demonstrated incident reduction achieved with the existingproduct III. A discussion ofthe potential exposure issues associated with the applicator device. Background on Wellmark 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 ofnormal production scale-up. (and hence are not available priorto registration approval.) IV. Briefcomments on the label, to provide some additional background information that may be useful in evaluation. Based on this discussion, Wellmark believes that theconsumer bellefit for this product will be significant, and we askthe EPA to allow the productto be registered under a Category R300 fast-track application. Ifyou have questions regarding this submission, orrequire 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 of8Please roadinstructions on reverse before completing**f"'~m** Form Approved OMB No 2070-0060 Approval expires 228.95


### - ,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 InternationallRF2164AfT COMBO 13

-- ----._- 5. Name and Mdress ofApplicant I Registrant (tnctude ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)

WelJmark Intemational (b)(i), my product is similaror identical in composition and labeling to: 1501 EastWoodfield Road, Suite 200W EPA Reg. No Schaumburg, ))Iinois 60t73 -------**---~**---- Product Name

--- 

# o Check ifthis isa newaddress Section M II 

# oAmendment
- Explain betow. 

# o Final printed labels in response to Agency letterdated 

# o Resubmission in response toAgency letterdated

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

# o"Me Too" Application 

# o Notification

- Explain below. 

# o Other

- Explain betow.

- Explanation: Use additional page(s) it necessary. (For section Iand section II-I Enclosed, please find application materials to support registration ofa new pesticide product, formulated as a dog topical application forfleas and ticks. This product contains the active ingredients etofenprox, PSO and S-methoprene, and is chemically identical to ourexisting registration, 2724-796. It is submitted as a new product registration because it is packagedwith a unique applicator device, but is substantially similarto the existing product. Because it is similar in use pattem and chemistry, we ask it be considered under PRIACode R300. A copy ofthe check for $1434 that was sent to the lockbox is enclosed. For questions, please contactJames McFadden, Tel: 847-330-5369; Fax: 847-330-5391; E-mail:jmcfadden@central.com
Section

- III 1. Material This ProductWilt be Packaged tn:



### ---- - Child-Resistant Packaging Unit Packaging Water SolUble Packaging 2. TypeotContainer

### @y~ 

# @Y"**~M""** 

# @Y" X No X No X Plastic X No Gtass If''Yes Unit No. per If"Yes Unit No. per Paper**~** Certificaflon musfbe 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. locationofLabet Directions



# o label 

# o Container

### t~_I_:~_~_ 9.0 cc tubes, 1 to 48-packs**~onLabel** On Label Accompanying**Pro~.I:I..~·:'** . 6. Mannerin Which Label isAffixed to Product 

# § Lithograph 

# o Other printed on cardboard Paperglued Stenciled Section M IV 

## • 1. Contact Point (Complete Items directly**be!~w**forIdentification ofindfvidualto be contacted, ifnecessary, to process this app:iLo:ix.] Name nUe 

# ITelepiuA.J No.**(tnctu"~**Area Code) James McFadden Sf. Regulatory Project Manager (841) :':;'0-5369

.**~---** Certification 

## I 6. DatE' AppliC'ltion 

# , Recei•.;;.; Icertify thatthe 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 mybe punishable byfine or imprisonment or both**!~I'lmped}** underapplicable 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 

### -Form approved. OMS No. 2070..0060, 2070-0057. 2070·0107, 2070-0122, 2070-0164. 

# &EPA
United States Environmental ProtectionAgency 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 ofConfidential Statement of Formula (EPA Fonn 8570-4)



### 11119/2010 As an authorized representative ofthe appticant for registration ofthe product identified above, I certify that: (1) This product contains the following active ingredient(s): 

### S-Methoprene Etofenprox Piperonyl Butoxide
(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging anotherproduct which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 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 ofFonnula (EPA FORM 8570-4) forthe above identified product is attached to this statement. That fonnula statement indicates, by company name, registration number, and product name, the source ofthe 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) Thefollowing active ingredients in this product qualify forthe fonnulator's exemption.

. , Source , Active Ingredient Product Name Registration Number 

### Etofenprox Piperonyl Butoxide**SignatuL.~** Name and TiUe Date 

### James McFadden, Reg, ProjectMgrc 11119/2010

. . EPA Fonn 8570 27 (Rev. 06 2004) Copy 1 EPA Copy2 -Applicant copy

# '''" erove 

# ". , . F dOMBN 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 ActNotice: The public reporting burden for this collectionofinformation is estimated to average 1.25 hours per responsefor 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 commentsregardingburden estimateor any otheraspectofthis collection ofinfonnation, including suggestions for reducing theburden to: Director,CoUection Srrn!egies Division (2822T), U.s. Environmental ProtectionAgency, 1200 PennsylvaniaAvenue, N.W., Washington, DC 20460. Do no! send the completed fonn to this address. Certification with Respectto Citation ofData 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, 20to General Use Pattern(s) (list all those claimed forthis proc:luct usin(:l 40 CFR Part 158) Product Name Pets and domestic animals (dogs) RF2164 /iffCOMBO NOTE: Ifyourproduct is a 100% repackaging ofanotherpurchased 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 aData-Call-tn Notice, and have included with this form a list ofcompanies sent offers ofcompensation (the Data Matrix form should be used forthis purpose).

SECTION t: METHOD OF DATA SUPPORT (Check one method only) 

# 0 Iam using the cite-all method ofsupport, and have included with this form 

# [2] Iam using the selective method ofsupport (or cile-all option. a list ofcompanies sent offers ofcompensation (the Data Matrix form underthe selective method), and have included with this form a should be used for this purpose). completed list ofdata requirements (the Data Malrix form must be used). SECTION II: GENERAL OFFER TO PAY !Required if using the cite-all method orwhen using the cite-alt option underthe 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 ofthis application, 10 the extent required by FIFRA.

SECTION III: CERTIRCATION Icertify thatthis application for registration, this form for reregislration, orthis Oala-Call-In response is supported by all data submitted or cited in the application for registration. the form for reregistration, orthe Oala-Call-In response. In addition, ifthe cite-all option or cite-all option under the selective method is indicated in Section I, this application is supported IYfall data in theAgency's files that (1) concern the properties or effects ofthis product or an identical or substantially similar product, or one or more ofthe ingredients in this product; and (2) is a type ofdata that would be required to be submitted underthe dala requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registralion ofa product ofidentical or similar composition and uses. I certifythat for each exdusive use study cited in support ofthis registration or rereg'lslration, that tam the original data submitterorthat t have obtained thewritten permission ofthe original data submitterto cite that study. Icertify that foreach study**c~ed** in support ofthis registration or reregistration that is not an exclusive use study, either: (a) tam the original data submitter; (b) t have obtained the permission ofthe original data submilterto use the studt in support ofthis application; (c) all periods ofeligibilityfor compensation have expired forthe study; (d) the study is in the public merature; or (e) Ihave notified inwriting the companythat 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) ofFIFRA; and (ii) to commence negotiations to determine the amount and terms ofcompensation. ifany, to be paid forthe use ofthe study. Icertify that in all instanceswhere an offerofcompensation is required, copies ofall offers to pay compensation and evidence oftheirdelivery in accordancewith sections 3(c)(1)(F) and/or 3(c)(2)(B) ofFIFRAare available and will be submitted to the Agency upon request. Should Ifail to produce such evidence to theAgency upon request, Iunderstand that theAgency may initiate action to deny, cancel orsuspend the registration ofmy product in conformity with FIFRA. I certify that the statements Ihave made on this form and all attachments to itare true, accurate, and complete. Iacknowledge that any knowingly false or misleading statementmay be punishabte by fine or imprisonmentor both underapplicabte 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 Paperversions avarlable. Submit only Paperversion

. 

## .UNITED STATES ENVIRONMENTAL PROTECTION AGENCY FormApproved OMS Nos. 2070-0060; 2070-0057; 1200 PennsylvaniaAvenue, N.W, 2070-0107; 2070-0122; 2070-0164 WASHINGTON,D C 20460 Paperwork ReductionACINolica: Thepublicreporting burdenfor lhis collectionofinforrnaUonis eslimated 10average 0.25hours perresponsefor regislralion activilies and 0.25hours perresponse for reregislration and special reviewactivities, including limeforreading lhe**inslru~li~ns1~~.**compleling lhe necessaryforms. Sendcommenlsregarding lheburdenestimateorany olheraspectoflhis collection ofinformalion, inciuding suggestions for reducing lheburden 10: Olreclor, CollectionSlrate les DiviSion 2822 U.S, Environmenlal ProleclionAen ,1200Penns IvaniaAvenue, N.W. washin Ion DC 20460. Do nol send lheform 10 lhis address. DATA MATRIX Date: November 19, 2010 EPA Re No.lFile S mbol 2724-XXX Pae1of1 AppUcant's/Registrant's Name &Address WellmarklntemationaJ Product 1501 E. Woodfield Rd., Suite 200West RF2164 NTCOMBO 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 ofMaterials 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 EnforcementAnalytical 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

- WaiverRequest 47518509 Wellmark International OWN 810.3300 Efficacy· Fleas and Ticks 47518511 Wellmark International OWN 810.3300 Efficacy· Fleas andTicks 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 andTicks 47844002 WelImark International OWN 870.7200 TargetAnimal Safety Adult Dogs 47518510 WellmarkInternational 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 TargetAnimal Safety**~** General 47844001 Wellmark International OWN Signature

# ~-~ Name and Title Date James McFadden, Sr, Regulatory ProjectManager November 19, 2010**~** < 

### --, EPA Fonr1S570-35 (12-2003) Eleclronlcand PaperversionSavailable, Submilonlypaperversion.**Fo~m** Approv,eci OMB ,Nos. 2070-0060; 207G-Q057; 207Q.0107; 20?()..Ot22; 2070-0164

ManagerUNITED 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; 2070-0164UNITED 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",Ie 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**'-".-~------"----~'.--,.- .--.~~**  -----,. '---EPA Form 8570-4 tRev. 9-94)

## IQe.r~ 'ifFroved. -eor 1\01\- -liDO!, V$e., 

# l<C.- %0 WMe
- EPA File Copy (original) Yellow
-Applicant CQp)'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