EPA Reg. No. 2517-134 part 2
1

Material to be added to an e-Jacket or Jacket 

Reg. No. 2 ')/7-i?C( 

Description: (."D,Jo flY I1vVIJIX\chwM;(-

1. 

2. 

¥ Placement within the e-Jacket/Jacket 9tI Default: (chronological, top = newest) 

o File Location: (PDF page number) 

'rf Send to Data Extraction contractors this material: 

. 191 Newly stamped accepted label 

Yo Notification 

o NewCSF 

o Other: __________ _ 

Attach this coversheet to the top of the material or jacket. It must be 

well-organized and clipped together - NOT STAPLED. Then give the 

material with this coversheet to staff in the Information Services 

Center (Room S-4900). 

Reviewer's Name: Rosanna Louie 

Phone: 308.0037 Division: RD 

Date: 1\ fc'132-0ll 
2

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Sergeant's Pet Care Products, Inc. 

c/o lvIr. James Messina, Exponent, Inc. 

1150 Connecticut Avenue, NW 

Washington, DC 20036 

FEB - 3 2011 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Amendment to Sergeant's Fipronil + Methoprene Dog Squeeze-On 

EPA Reg. No. 2517-134 

Submission dated January 19, 2011 

Decision No: 443571 

Dear Mr. Messina: 

The labeling referred to above, submitted in connection with registration under the 

Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is acceptable. Two (2) copies 

of the finished labeling must be submitted prior to releasing the product for shipment. 

A stamped copy of the label is enclosed for your records. If you have any questions 

regarding this action, please contact Rosanna Louie-Juzwiak at (703) 308-0037. 

Sincerely, 

Richard Gebken 

Product Manager 10, Insecticide Branch 

Registration Division (7505P) 

Enclosure: Sergeant's Fipronil + Methoprene Dog Squeeze-On, Stamped Accepted 
3

Sergeant's Master Label 

28 January2011 Amendment Version 10.2 EPA No. 2517-134 

Information in 1 of 9 EPA SAL 4 Nov 2010 

[Optional text appears in brackets - the final product label may include some or all of the 

optional text on front, back or side label panels. _~] 

Sergeant's Fipronil + Methoprene Squeeze-On for Dogs 

[ABNs] 

[(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] 

[(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for dogs] 

ACCEPTED 

[SentryProline (Spot On) for dogs] FEB - 3 2011 

[[SENTRY®] FIPROGUARDTM PLUS for dogs] 

[[Sergeant's®] PRONYL OTC'M PLUS for dogs] 

Under the Federal Insecttctde, 

FungIcide. and Rodent1clde Act, 

as amended, for the pest1c1de 

Regtstered under 

[Apply to puppies over 8 weeks old] 

[Apply to puppies 8 weeks or older] 

[Mosquitoes] 

,. EPA ~Reg. No. Z$l 7 I 34 I@>O,<>T I WEON 

i CATS 

, 

[Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28 days] 

[Adult Fleas] 

[[Kills [adult] Fleas [for up to three months]] 

[Kills newly emerged adult Fleas before they lay eggs] 

[Kills Adult Fleas, which may be a source of [flea allergy dennatitis] [, flea bite anemia]] 

[Kills Fleas Up to [4 weeks] [1 month] [30 days]!] 

[If dog is at high risk for flea reinfestation a once month application may be needed] 

[Multiple Infestations] 

[Kills chewing lice [and controls mites that may cause sarcoptic mange]] 

[Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] 

[Kills fleas, flea eggs, ticks, chewing lice [&] [and] [mosquitoes]] 

[Kills fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae [&] [and] [prevents the 

development of flea pupae]] 

[Kills Fleas, Ticks [&] [and] [Mosquitoes]] 

[Breaks the Flea Life Cycle [for up to three months]] 

[Monthly flea, tick, [mosquito,] chewing lice and flea egg protection] 

[Monthly flea, tick, [mosquito] and chewing lice protection] 

[Kills fleas, ticks, [mosquitoes,] flea eggs, and chewing lice] 

[[Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing 

lice, flea eggs, flea larvae [&] [and] prevent the development of flea pupae]] 

[[Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, 

flea eggs [&] [and] flea larvae] 

[[4 Week] [1 month] [30 day] [Flea [and] [&] Tick Treatment] 

[[Four (4) Week] [1 month] [30 day] [Flea, Tick, and Chewing Lice Control] 

[[Four [4] Week] [1 month] [Flea, Tick, [Mosquito] and Chewing Lice Control] 

[Use [brand name] monthly to break the flea life cycle.] 

[Use [brand name] monthly to control ticks and chewing lice] 
4

Sergeant's Master Label 

28 January 20ll Amendment Version 10.2 EPA No. 2517-134 

Information in 2 of 9 EPA SAL 4 Nov 2010 

[Monthly flea, tick, [mosquito,] flea egg, flea larvae and chewing lice pr<Jte(;tic,n.] 

[Once A Month Flea and Tick [Application][Treatment] 

[[4 week] [1 month] [30 day] Flea and Tick [Application] [Treatment]!] 

[Kills Fleas, [and] Ticks for up to [4 weeks] [1 month] [30 days]!] 

[Kills Fleas, [and] Ticks [and Mosquitoes] for up to [4 weeks] [1 month]!] 

[Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [1 month] [30 days]] 

[Ticks] 

[Kills Ticks including those that may transmit Lyme disease] 

[Kills Ticks for Up to [4 weeks] [1 month] [30 days]!] 

[Kills (deer) ticks [including those that may transmit Lyme Disease] [for up to [4 weeks] [1 

month] [30 days] [per application]] 

[Kills all stages of deer ticks] 

[Kills Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] [30 days]] 

[Kills [brown dog ticks], [American dog ticks,] [and lone star ticks] [and deer ticks] 

[(Rhipicephalus sanguineus)] [for up to [4 weeks] [1 month] [30 days]] 

[Kills American Dog Ticks [(Dermacentor variabilis)] for up to [4 weeks] [1 month] [30 days]!] 

[Flea Eggs and Larvae[ 

[Controls flea reinfestation for up to [12 weeks] [3 months]] 

[Kills adult fleas, flea eggs, flea larvae and prevents the development of pupae for up to [three 

months] [12 weeks].] 

[Effectively controls all stages of the flea (including adult fleas, flea eggs, flea larvae and 

prevents the development of flea pupae)] 

[Effective against all stages of the flea (including adult fleas, flea eggs, flea larvae and prevents 

the development of flea pupae)] 

[If dog is at high risk for flea reinfestation a once month application may be needed] 

[Prevents from developing, flea eggs [larvae] [pupae] for up to [3 months] [12 weeks]] 

[With (S)-methoprene Insect Growth Regulator [IGR] which Breaks the Flea Life Cycle] 

[With (S)-methoprene to Break Flea Life Cycle] 

[With Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

[Dual Action [!]:Fipronil with (S)-methoprene IGR [insect growth regulator] Effectively Breaks 

the Flea Life Cycle] 

[Dual Action [I]: Effectively Breaks the Flea Life Cycle [ill 

[Kills Flea Eggs & Flea Larvaefor [up to 3 months] [up to 12 weeks]!] 

[Prevents Flea Eggs From Developing Into Biting Adults] 

[Prevents all stages of the flea life cycle from developing] 

[Controls reinfestation of fleas for up to 3 months] 

[Effective against all stages of the flea life cycle] 

[Effectively controls all stages of the flea life cycle] 

[All Others] 

[For Dogs and Puppies 8 weeks of age or older] 

[Controls mites that may cause sarcoptic mange] 
5

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in [ ] is optional. Page 3 of9 EPA SAL 4 Nov 2010 

[For Dogs [up to 221bs.], [23-441bs.], [45-88 Ibs.], [89-1321bs.] 

[Fast Acting] [Long Lasting] 

[Prevents reinfestation of listed pests for [4 weeks] [1 month]] 

[Easy to use [application]] 

[Apply monthly] 

[[A once monthly application required][Apply monthly to control] [for] chewing lice] 

[Rapid elimination of chewing lice infestations] 

[[Three] [3] Applications] andlor [3 Month Supply] or [12 Week Supply] 

[Best if used year round!] 

[(ICON Showing [4 week] [1 month] [30 day] Protection)] 

[4 Week Dose!] [1 Month Dose!] [30 Day Dose!] 

[Specially Formulated for Dogs and Puppies 8 weeks of age or older] 

[[Free] Calendar Stickers Inside!] 

[Apply once every [4 weeks] [month] [30 days]!] 

[WaterproofJ 

[Can be used on breeding, pregnant and lactating [bitches] [female] [dogs]] 

[[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [inside lJ 

[Can be used on puppies 8 weeks of age and older] 

[Convenient spot treatment] 

[Easy to Use [ApplicationlJ 

[Effective after bathing and exposure to water and sunlight] 

[For year-round protection, apply [Brand name] monthly] 

[Fipronil (9.8%) + (S)-methoprene (8.8%)] 

[Lift [here] for more information] 

[Contains Fipronil and (S)-methoprene[,] [-] the active ingredients used in Frontline Plus®*] 

[*[Brand name] is not manufactured by or distributed by Merial. Frontline Plus® is a 

registered trademark of Me rial.] 

[U.S. Patent No. 5,567,429] 

[3 applications] 

[For year-round protection, apply [Brand name] monthly] 

[Effective after bathing and exposure to water and sunlight] 

[Stops and prevents infestation of listed pests for [4 weeks] [1 month]] 

[Stops existing infestation and prevents establishment of additional infestation of listed pests] 
6

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-l34 

Information in I is 40f9 EPA SAL 4 Nov 2010 

[For use ONLY on dogs 

[Up to 22lbs] 

123-44lbs] 

[45-88lbs] 

[89-l32lbs] 

[over 8 weeks of age II 

[For Dogs & Puppies 8 weeks or older andllup to 22lbs.1 

IFor Dogs 23-44lbs.1 

[For Dogs 45-88 lbs.] 

IFor Dogs 89-132lbs.1 

ACTIVE INGREDIENTS: 

Fipronil ........................................................................ 9.80% 

(S)-methoprene ............................................................ 8.80% 

OTHER INGREDIENT**: .................................... 81.40% 

TOTAL 100.00% 

I**diethylene glycol monoethyl etherl 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See [Back] [or] [Side] [Label Panel[sll for Additional Precautionary Statements 

NET CONTENTS: 

{END - FRONT PANEL} 

[3] [three] 0.023 fl oz (0.67 mL) applicators 

[3] [three] 0.045 fl oz (1.34 mL) applicators 

[3] [three] 0.091 fl oz (2.68 mL) applicators 

[3] [three] 0.l36 fl oz (4.02 mL) applicators 

="" 
7

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in 50f9 EPA SAL 4 Nov 2010 

[[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (lGR) to effectively 

kill fleas and ticks [(including those that may transmit Lyme Disease).] [The active ingredients in 

[brand name] feature a sustained release fonnula developed for fast acting [and long lasting] 

control of fleas, ticks, [mosquitoes] and chewing lice for up to [1 month] [[4][four] weeks] on 

dogs.] 

[Brand name] 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation. Avoid 

contact with skin, eyes or clothing. Wash hands thoroughly with soap and water after handling and 

before eating, drinking, chewing gum, using tobacco, or using the toilet. 

HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 8 

weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product. 

[Some dogs may experience temporary startle effects when any product is applied.] Dogs may 

experience some temporary irritation at the site of product application. If signs persist, or become 

more severe within a few days of application, consult a veterinarian immediately. If your dog has an 

unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain 

medications can interact with pesticides. Consult a veterinarian before using on medicated, 

debilitated or aged dogs. Call 1-800-781-4738 for 24-hour assistance. 

FIRST AID 

If swallowed: Call a poison control center or a doctor immediately for treatment advice. 

Have person sip a glass of water if able to swallow. Do not induce 

vomiting unless told to do so by a poison control center or doctor. Do not 

give anything by mouth to an unconscious person. 

Ifin eyes: Flush eyes with plenty of water. Call a doctor ifirritation persists. 

If on skin: Wash with plenty of soap and water. Get medical attention if irritation 

persists. 

HOTLINE NUMBER 

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

going for treatment. You may also contact 1~800~78IA738 for emergency medical treatment 

infonnation. 
8

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

60f9 EPA SAL 4 Nov 2010 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product ih a manner inconsistent with its labeling. 

DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU 

AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL 

DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL 

USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. 

Do not use on puppies under 8 weeks of age. [Do not split one tube between dogs.] [Do not use 

multiple tubes on one dog.] Weigh your dog to be sure you are applying the right dose fonnulated 

for the weight of your dog. Consult a veterinarian before using this product on debilitated, aged, or 

medicated dogs. Can be used on breeding, pregnant, or lactating dogs. Consult a veterinarian 

before using on dogs with known organ dysfunction. Dogs may experience some temporary 

irritation at the site of product application. Certain medications can interact with pesticides. 

Sensitivities may occur after using ANY pesticide product on dogs. If signs of sensitivity occur 

bathe your dog with a mild soap and rinse with large amounts of water. If signs continue, consult a 

veterinarian immediately. 

{Outer Packaging) 

How to open: Remove product tubes [vial] from the package. Separate one tube from the others. 

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the 

narrow end at the notches with scissors. 

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to 

apply all of the solution to the dog's skin, as directed below. Do not apply more often than once 

every 4 weeks. 

[Optional drawings that mayor may not appear on finished label] 

FREQUENCY OF APPLICATION 

Use [brand name] monthly for complete control of flea, tick [and] chewing lice [and mosquito] 

infestations. [Studies show that] [brand name] kills adult fleas for up to three months. Apply 

monthly if your dog is at high risk for flea reinfestation [, or in a highly infested environment]. 

Apply monthly to control ticks, [mosquitoes] and chewing lice. [Brand name] remains effective, 

even after bathing, water immersion, or exposure to sunlight. Allow treated area to dry thoroughly. 

Do not reapply for 30 days. 

For Dogs Weighing up to 221bs. [including small dogs and puppies, 8 weeks or older]: 

{For cartons containing 0.67 mL (0.023 fl oz) applicator tubes} 

Apply one tube (0.67 mL )(0.023 fl oz) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 
9

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Infonuation in 7 of9 EPA SAL 4 Nov 2010 

For Dogs Weighing 23 - 441bs. 

{For cartons containing 1.34 mL (0.045 fl oz) applicator tube} 

Apply one tube (1.34 ml)(0.045 fl. oz.) [from the back of the neck to a point midway between the 

neck and taiL] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 45 - 881bs. 

{For cartons containing 2.68 mL (0.091 fl oz) applicator tube} 

Apply one tube (2.68 ml)(0.09I fl. oz.) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 89 - 1321bs. 

{For cartons containing 4.02 mL (0.136 fl oz) applicator tube} 

Apply one tube (4.02 ml)(0.136 fl. oz.) [fTom the back of the neck to a point midway between the 

neck and taiL] [as a spot on the dog's back between the shoulder blades.] 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool 

(below 77°F [25°C]) dry place inaccessible to children and pets. Do not refrigerate. Protect from 

direct sunlight. 

CONTAINER DISPOSAL: If empty: Non-refillable container. Do not reuse or refill this 

container. Offer for recycling if available. If partly filled: Call your local solid waste agency for 

disposal instructions. Never place unused product down any indoor or outdoor drain. 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this product, 

user or buyer accepts the following warranty. The directions for use of this product are believed to 

adequate and must be followed carefully. It is impossible to eliminate all risks associated with the 

use of this product. Unintended consequences may result because of unknown factors. All such 

risks shall be assumed by the user or buyer. Sergeant's is committed to providing high quality 

products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or 

implied, of merchantability or of fitness for a particular purpose or otherwise, that extend beyond 

statements on this labeL To the extent consistent with applicable law, Sergeant's, the manufacturer, 

or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the 

extent consistent with applicable law, the exclusive remedy of the user or buyer shall not exceed the 

purchase price paid.] 

[If you have questions or comments about this product, please write: [Sergeant's] [SENTRY] 

Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.] 

In Case of Emergency, call: 1-800-781-4738 

Non-Emergency, call: 1-800-224-PETS (7387) 

[Coupon(s) inside or on outside of box ] 

[Made in USA] 
10

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in· 8of9 EPA SAL 4 Nov 2010 

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

Omaha, NE 68154·0399 

EPA Reg. No. 2517-134 

EPAEs!. No. 25l7-TN-l [XXXXX-XX-XXX] 

[BAR CODE AREA] 

u.S. Patent No. 5,567,429 

[How to Apply - May contain graphics illustrating product use, e.g., dog with a drop falling 

onto its neck from a vial on front, side, or back carton label and/or applicator labeling.] 

[Application Instructions] [Directions for Use] 

How to open 

1. Remove product tubes [vial] from the package. 

2. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and 

away from the face and body, cut off the narrow end at the notches with scissors. 

How to apply 

1. Invert tube over dog and use open end to part dog's hair. 

2. Squeeze tube firmly to apply all of the solution to the dog's skin [as a spot to the dog's back 

between the shoulder blades.] [or] [from the back of the neck to a point midway between the 

neck and tail.] 

[Optional drawings that mayor may not appear on finished 

label] 

~ ........ . 

¥-t ...... . ~ . " , , , " ,"', ',' , . . . 

[Flea life cycle diagram] [Flea Life Cycle] 

]Sample coloring and layout may 

be different on final label] 

[Look at the Label (Look at the Label icon) [Easy] 

6 Step [Easy] [Spot On] [Squeeze·On] [Topical] Checklist] 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use dog products on cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

FLEALARVAE 
11

Sergeant's Master Label 

28 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in 9 of9 EPA SAL 4 Nov 2010 

[Brand narne[ 

[3 Month [Treatment] [Application] Tracker] 

[For yearMfound protection, apply [Brand name] monthly.] 

[Pet's Name (Empty blank for owner to fill in name)] 

[First] [1st] [Second] [2nd] [Third] [3rd] 

[Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: MM/DD/YY)] 

[calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply 

[brand name] in 30 days.] 

[Monthly Application Reminder Magnet (image of reminder magnet)] 

[Enclosed for your convenience is an application reminder magnet. Push the (reset) button, and the 

reminder light will blink twice. The reminder tag is now set for 30 days. At the end of 30 days the 

reminder light will blink, reminding you to reapply [Brand name]. Press the button once and the 

blinking light will stop. Press the button again and this will reset the timer for another 30 days.] 

'" Adult Flea @ Adult Flea 

... flea eggs ~ flea eggs 

..., flea larvae 

_ fleapupae 

Brown Dog Tick 

Deer Tick 

American Dog Tick 

chewing lice 

Lone Star Tick 

-""" mosquIToes 

[Optional graphics above 

-PACKAGE 

Front Label 

(3) flea larvae 

~ fleapupae 

® Brown Dog Tick 

® DeerTIck 

@ American Dog Tick 

® chewing lice 

@ Lone Star Tick 

~ mosquIToes 

Back Label 

{Brand Name} [cat graphic with line through1 

For dogs [up to X][X-Y]lbs 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions before 

Fiproni19.8% w/w, (S)Mmethoprene 8.8% w/w using. Use scissors to open. 

0.023 fl oz (or) 0.045 fl oz (or) 0.091 fl oz (or) 

O.136floz llabelcode} 

{END - TUBENIAL COPY} 

EPA REG. No. 2517-134 {label code} 
12

Trlllcking 

Crelllte Resubmission 

FFS Letters 

Action Code History 
13

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

FEB - 3 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Sergeant's Pet Care Products, Inc. 

c/o Mr. Kelly Hoskins 

2625 South 158lli Plaza 

Omaha, NE 68130-1770 

Subject: Accelerated Review of a Minor Fonnulation Amendment per PR Notice 98-10 to 

Revise the Current Basic CSF for Sergeant's Fipronil + S-methoprene SqueezeOn for Dogs 

EPA Reg. No. 2517-134 

Your Submission Dated November 23, 2010 

Decision No: 443624 

Dear Mr. Hoskins: 

We have no objection to the use of the proposed alternate fonnulations requested in your 

application submitted November 23, 2010. The amended alternate CSFs nos. 3 and 4, both dated 

November 23, 2010, have been added to the file for the subject product. 

If you have any questions regarding this action, please contact Rosanna Louie-luzwiak at 

(703) 308-0037. 

Richard Gebken 

Product Manager 10, Insecticide Branch 

Registration Division (7504P) 
14

DATA PACKAGE BEAN SHEET 

Date: 30~Dec~2010 

Page 1 of 1 

* * * Registration Information * * * 

Decision #: 443624 

DP #: (385167) 

NON PRIA 

Parent DP #: 

Submission #: 888047 

Registration: ~?:t7' .. :1_3:04 ___ ~ __ ~_~_~_GJ:A_~T_~ ___ FJf'.R.9NI_1,._ + METH.oPRENE SQUEEZE::9N F9.~ 

Risk 

Company: 

Manager: 

2517 

~_1\I1 __ 1_0_ 

- SERGEANT'S 

~_~ic_h_ar9 __ co_e_b_~E!n 

PET 

__ -_F.?~) 

CARE 

__ ~_5:_E3?~_1 

PRODUCTS, 

__ R(I_(Irn_1t 

INC. 

PYI 5-7237 

~c~tl~i Risk Manager Reviewer: Rosanna Louie RLOUIE 

Sent Date: 29-Dec-2010 Calculated Due Date: 21-Feb-2011 

Type of Registration: Product Regi~lration :. Secli_on 3 

Action Desc: (~_~>"~C?_I3f.J!LJ_LA: C:_HANc:;~;:rEC::Hr.J_I_C:,ll,L_; __ 

Ingredients: ~_O~_4_02, __ i?_:_I>i1~t~opr,,_~e(8.8%) 

1_?_9_1_?I_, __ ~_ipr.c>n_il(~:a%.l. __ 

Edited Due Dale: 

* * * Data Package Information * * * 

Expedite: 0 Yes. No 

DP Ingredient: 105402, S-Methoprene 

1291~1., Fipr.oni! 

DP Title: A!ternate CSF Review 

Date Sent: 30-Dec-2010 Due Back: 

CSF !ncluded: • Yes 0 No Labe! !ncluded: 0 Yes. No Parent DP#: 

As.signed To 

Organization: RD f TR~ 

Team Name: CHEM 

Reviewer Name: 

Conlractor Name: 

Date In Date Out 

* * * Studies Sent for Review * * * 

No Studies 

;z.:-\1.(c" 

Last Possible Science Due Date:&-cp~lh2Q1J~ 

Science Due Dale: 

Sub Data Package Due Date: 

~ \:\ ~~l<) "W,/ \ \~ rr5 

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

No Additional Data Packages 

* * * Data Package Instructions * * * 

Attn CHEM: Please review the attached a!ternales #3 and #4 CSFs for approval. Contact Rosanna Louie-Juzwiak at 308.0037 with any 

questions. 

Attachments: 

Cover letter 

App!1cant-supp!ied CSFs uacket unavailable to retrieve paper copy of approved CSFs) 

draft AMernate #3 and #4 CSFs 
15

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OPPTSIOPP/RDfTRB/PRODUCT CHEMISTRY TEAM 

WASHINGTON, D.C. 20460 

DATE OUT: January 19,2011 

DP BARCODE No.: 385167 

Company Name:SERGEANT'S PET CARE PRODUCTS, INC. 

REG. No.: 2517~134 

Action Code: 345 

Decision No: 443624 

SUBJECT: Product Chemistry Review of the EP, "Sergeant's Fipronil + Methoprene Squeeze-On for 

Dogs" 

PC Code(s): 105402; 129121 .1, _;() Food Use: No. 

FROM: William Herald, Microbiologist, REHSIRS 1/~/' , I "~:~ /71) I G ( I ) 

TO: 

Product Chemistry Team ( I '1 ~ ~/(..f\./\ I 

Technical Review Branch/RD (750SP) / 

Rosanna Louie I Richard Gebken, RM 13 

Insecticide Branch I RD (7505P) 

With a fetter dated November 23, 2010, registrant has submitted newly proposed alternates CSF 

3 and 4(dated 11/23.10) for the end use product, " Sergeant's Fipronil + Methoprene SqueezeOn for Dogs." 

The alternate formulations have been submitted to add a new sources for the active ingredients. 

TRB has been asked 10 evaluate the revised CSF alternate formulation and determine their 

acceptability. 

SUMMARY OF FINDINGS 

1.:. The proposed end use product contains Fipronil ) [Reg. No. and

[Reg. No. ); or Reg. No. as the 

active ingredients with the product label claims of 9.8% and 8.8% respectively. 

LThe proposed two CSF(s), Alt. Nos. 3 and 4 (both dated 11/23/10) are filled out correctly 

and completely. The nominal concentrations of the active ingredients concur with the product 

label in compliance with PR Notice 91-2, and Title 40 CFR § 152.43. All the non-food use inert 

ingredients present in the formulation have been approved by the Agency (1/19/11). The 

certified upper and lower limits of the active and inert ingredients are in compliance with 

standard certified limit tables set forth in 40 CFR § 158.350(b)(2). 

~ The proposed alternate CSF(s), Alt. Nos. 3 and 4 (both dated 11123/10) are substantially 

similar in chemical composition and physical-chemical composition to the current basic CSF 

(dated 8/31/10). 

CONCLUSIONS: 

The TRB has reviewed the alternate CSF(s), Nos. 3 and 4 (both dated 11/23/10) and has 

determined them acceptable. 

W. J. Herald 2011 

*Product ingredient source information may be entitled to confidential treatment*
16
Pages 17 and 18 are claimed confidential by the submitter upon submission to the agency and are not included in this copy.
19

Please rear! inslructions on reverse before G leting form Form Approvel J1B No 2070-0060 Approval expires 05-31 98 . 

United States [.1Registration OPP Identifier Number 

EPA Environmental Protection Agency D.Amendment 

Washington, DC 20460 ~ Other 

Application for Pesticide ~ Section I - 1. Company/Product Number 2. EPA Product Manager 3. Prooul;eo t..;lassiflcation 

2517-134 Richard Gebken 

4. CompanyfProduct (Name) PM#10 ~None DRestricted 

Sergeant's Pel Care Products, Inc.! Sergeant's Fiproni! + S-methoprenc 

Squeeze-On For Dogs 

5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordanc~ ·/dt'l F~FRA S'Jctic.1'3( c )(3)(b)(I), my 

Sergeant's Pet Care Products, Inc. product is similar or identical in composillC'!' and labelhg to: 

2625 South I 58th Pla7..a 

Omaha, NE 68130-1770 EPA Reg. No. 

-- Product Name 

o Check if this is a new address 

Section II 

D Amendment - Explain below. D Final printed labels in response to Agency letter dated XX-XX-XX 

D Resubmission in response to Agency letter dated D "Me Too' Application 

D Notification - Explain below. ~ Other - Explain below. 

Explanation: Use additional page(s) if necessary. (For section I and Section II.) 

Submission of an Alternate #2 CSF and Formulator's Exemption Statement as a minor formulation amendment pursuant to 

PR Notice 98-10. 

Section III 

1. Material This Product Will Be PackaQed In: 

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

~Yes· [g] y" Oy" o Metal 

ON' ON' [g] N, ~ Plastic 

If "Yes" No. per If "Yes" No. per DGlass 

·Certification must Unit Packaging wgt. Container Package wgt. Container 

DPaper be submitted 0.023 n oz (0.50 011) 3 vials 

0.04511 oz (1.34 ml) I I Dother (Specify) Plastic Bag 0.091 11 oz (2.68 ml) 

0.13611 07.: (4.02 ml) 

3 Location 01 Net Contents Information 4. Size(s) Retail Container 5. Location of label Directions 

~Label o Container 0.023 n oz (0.50 ml). 0.04511 oz(I.34 ml), 0.091 n DOn Can 

oz (2.68 ml), 0.136 n oz (4.02 ml) {glOn Labeling accompanying product 

6. Manner in Which Label is Affixed to Product ~lithOgraPh cg]Other 

DPaper glued 

DStenciled 

Section IV 

1. Contact Point (Complete items directly befow for identification of individuaf to be contacted, if necessary, 10 process this application.) 

Name Title Telephone No. (Include Area Code) 

Kelly R. J·loskins Manager ofTcchnical Affairs 402-938-7079 

Certification 6. Date Application 

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. 1 Received 

acknowledge that any knowingly false or misleading statemenl may be punishable by fine or imprisonment or both (Stamped) 

under applicable law. 

2. S;g",I"~ to:: J;;//~ 3. Title 

BY, )!:, .. Manager of Technical Affairs 

4. Typed Name: / Kelly R. Hoskins / / 5. Date: 11/23/2010 
20

Form approved. OM8 No. 2070-0060, 2070-0057, 20/0-0107, 2070-0122,2070-0164 . 

.sEPA 

United States 

Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Applicant's Name and Address EPA File SymboJlRegistration Number 

Sergeant's Pet Care Products, Inc. 2517-134 

2625 South 158th Plaza Product Name 

Omaha, NE 68130-1770 Sergeant's Fipronil + S-methoprene Squeeze-On II 

Date of Confidential Statement of Formula (EPA Form 857()-4) 

11/23/2010 

As an authorized representative of the applicant for registration of the product identified above, I certify that; 

(1) This product contains the following active ingredient(s): 

Fipronil (9.8%) 

S-methoprene 01.8%) 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that aci,ve ihgri-dient if' t'le rnnufacturing, 

formulation or repackaging enother product which contains that ective ingredient which is registered under FIFRA Sectioj, 3; i::- ,'lurchased by 

us from another person and meets the requ·,rements of 40 CFR section 158.50(e)(2) or (3). ' ' , ' , ~ 

(3) Indicate by checking (A) or (8) below which paragraph applies: 

11 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this s:;.h,r,lf..nt. 

That formula statement indicates, by company name, registration number, end product name, the source of the ective ingrepir-r;t(s) listed in 

paragreph (1). 

OR 

, (8) The Confidentiel Statement of Formula (CSF)(EPA Form 8570-4) referenced above end on file with the EPA is complete, current, an 

accurate and contains the information required on the current CSF. 

(4) The following active ingredients in this product qualify for the formulator's exemption. 

Source 

Active Ingredient Product Name Registration Number 

Fipronil Technical 

Fipronil Technical

S-methoprene 

S-methoprene

S7Z;, )LI ck Name and Title Date 

Kelly R. Hoskins, Manager of II 11/23/2010 

EPA Form 85~-27 (Rev. 06-2~ I Copy 1 EPA 

Copy 2 - Applicant copy 

*Product ingredient source information may be entitled to confidential treatment*
21

Tracking 

Create Resubmission 

FFS Lettet'$ 

Action Code History 
22
23
24

EXponent 

January 19, 2011 

Richard Gebken, PM10 

Office of Pesticide Programs (7504P) (AMEND) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + Methoprene Dog Squeeze-On 

EPA Registration Number 2517-134 

Dear Mr. Gebken: 

Exponent 

1150 Connccr;cut Avenue, NW 

Suite 1 100 

Washington, DC 2003(, 

telephone 202-772-4-900 

),nimile 20:2-772-4979 

www.cxponent.com 

In response to the Agency letter dated December 22, 2010, Sergeant's Pet Care Products, Inc. 

(Sergeants, EPA Company Number 2517) is responding to the Agency-initiated Required 

Label Amendment by submitting the following documents: 

(1) Cover letter; 

(2) Application for Pesticide Form (8570-1); and 

(3) Revised product label (five copies). 

Sergeant's has reviewed EPA's requested label comments and either incorporated them or 

revised them to include appropriate language to clarify the supported efficacy claim. Further, 

the revised label includes EPA's comments in the Notice of Registration dated November 4, 

2010. Please find enclosed a revised label for EPA's review and approval. 

If you have any questions, please contact me at 202-772-4932. 

rsJ!L·~ey \ - " 

J!mIes Messina 

Mthorized Representative for 

Sergeant's Pet Care Products, Inc. 

Enclosures 

cc: Kelly R. Hoskins, Sergeant's Pet Care Products, Inc. 
25

Please read instructions on reverse before comp/et1ng form. Form Aporoved. OMB No. 2070-0060. Aooroval eXIlires 05-31-98 

United States W _Registration OPP Identifier Number 

EPA Environmental Protection Agency D.Amendment 

Washington, DC 20460 ~other 

Application for Pesticide ~ Section I 

1. Company1Product Number 2. EPA Product Manager 3. Proposed Classification 

2517-134 Richard Gebken 

4. Company1Product (Name) PM#10 [gINone DRestricted 

Sergeanfs Fipronll + Methoprene Only Squeeze-On For Dogs 

5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)(b)(I), my 

Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 

2625 South 15Sth Plaza 

Omaha, NE6S130 EPA Reg. No. 

Product Name 

D Check if this is a new address 

Section II 

~ Amendment - Explain below. D Final printed labels in response to Agency letter dated XX-XX-XX 

~ Resubmission in response to Agency letter dated 12-22-2010 D "Me Too" Applicalion 

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

Explanation: Use additional page(s) if necessary. (For section I and Section II.) 

Submission of a response to EPA letter dated December 22, 2010 regarding an Agency-initiated labeling amendment. 

I PRIA .. . 

Section III 

1. Malerial This Product Will Be Packaaed In: 

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

[gJ Yes* [gJ Yes Dy" DMetal 

DNo D No ~ No [gj Plaslic 

If "Yes" No. per If "Yes" No. per DGlaSS 

*Certification must Unit Packaging wgt. Container Packagewgt. Container 

DPaper be submitted 0.023 fl OZ (0.50 ml) 3 vials 

0.045 fl oz (1.34 ml) I I DOther (Specify) Plastic Bag 

0.091 flo:;~.68ml) 

0.136 fl oz 4.02 mt) 

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

[gJLabel D Container 0.023 fl oz (0.50 ml). 0.045 fl oz I 1.34 m)), 0.091 fl DOn Can 

oz (2.68 mt), 0.t36 fl oz (4.02 mt) DOn Labelino accompanying product 

6. Manner in Which label is Affixed to Product DLithograph [gJOther 

-- DPaper glued 

DStenciled 

Section IV . 

1. Contact Point (Comple/e items directlv below for identifICation of individual 10 be contacted if necessaJY. to c.'DCEs;:;·:his ap;'licat:G.1.l 

-,-

Name Title I' Telephore No. ('nclude Area Code) 

James Messina Authorized Represcntative .1. 202-772-4932 

Certification ,. Date Application 

I certify th!~iitments I have made on this form and all attachments thereto are true, accurate and complete. I Received 

/CK.~~=ge t ny knowingly false or misleading statement may be puniShable by fine or imprisonment or both (Stamped) 

under a Ii Ie aw. 

~~tul h 3. Title 

- BY: Authorized Representative 

4. TYPed/Nre: James Messina 5. Date: 0111912011 

V 
26

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in [ ] is optional. Page I of 9 EPA SAL 4 Nov 20 I 0 

FRONT PANEL .. DOGSQUEEZE ON 

FIPRONIL+METHOPRENE 

[Optional text appears in brackets - the final product label may include some or all of the 

optional text on front, back or side label panels. The 'cRP required text will not change.] 

Sergeant's Fipronil + Methoprene Squeeze-On for Dogs 

[ABNs] 

[(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] 

[(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for dogs] 

[Sentry Proline (Spot On) for dogs] 

[[SENTRY®] FIPROGUARDTM PLUS for dogs] 

[[Sergeant's®] PRONYL OTCTM PLUS for dogs] 

[Apply to puppies over 8 weeks old] 

[Apply to puppies 8 weeks or older] 

]MosquitoesJ 

[Kills mosquitoes] rwithin 24 hours for up to 7 days] [and within 48 hours for up to 28 days] 

[Adult Fleas] 

[[Kills [adult] Fleas [for up to three months]] 

[Kills newly emerged adult Fleas before they lay eggs] 

[Kills Fleas, which may be a source of [flea allergy dermatitis] [, flea bite anemia] [and] 

[tapeworm infestations]] 

[Kills Fleas Up to [4 weeks] [I month] [30 days]'] 

[If dog is a high risk for flea reinfestation a once month application may be needed] 

[Multiple Infestationsj 

[Kills chewing lice [and controls mites that may cause sarcoptic mange]] 

[Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] 

[Kills fleas, flea eggs, ticks, chewing lice [&] [and] mosquitoes] 

[Kills fleas, ticks, mosquitoes chewing lice, flea eggs, flea larvae [&] [and] [prevents flea 

pupae]] 

[Kills Fleas, Ticks [&] [and] Mosquitoes] 

[Breaks the Flea Life Cycle [for up to three months]] 

[Monthly flea, tick, mosquito, chewing lice and flea egg protection] 

[Monthly flea, tick, mosquito and chewing lice protection] 

[Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice] 

[[Seven] [7] Way Protection to kill fleas, ticks, mosquitoes, chewing lice, i1eh eggs, flea'larvae 

[&] [and] prevent flea pupae]] 

[6 [Six] Way Protection to kill fleas, ticks, mosquitoes, chewing lice, flea eggs [&] Ear_oJ r1ea 

larvae] 

[[4 Week] [I month] [30 day] [Flea [and] [&] Tick Treatment] 

[[Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Chewing Lice Control] 

[Use [brand name] monthly to break the flea life cycle.] 

[Use [brand name] monthly to control ticks and chewing lice] 
27

Sergeant's Master Label 

19 January 20 II Amendment Version 10.2 EPA No. 2517-134 

Information in [ ] is optional. Page 2 of 9 EPA SAL 4 Nov 20 I 0 

FRONT PANEL DOG SQUEEZE ON 

FIPRONIL+.METHOPRENE 

[Monthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.] 

[Once A Month Flea and Tick Treatment] 

[[4 week] [I month] [30 day] Flea and Tick Treatment!] 

[Kills Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I month] [30 days]!] 

[Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [I month] [30 days]] 

[[Images of the different kinds of bugs killed with a line drawn through each bug]] 

(Ticks] 

[Kills Ticks including those that may transmit Lyme disease] 

[Kills Ticks for Up to [4 weeks] [I month] [30 days]'] 

[Kills [all stages of] (deer) ticks [before they can] [that] [transmit Lyme Disease,] [for up to [4 

weeks] [I month] [30 days] [per application]] 

[Kills Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] [30 days]] 

[Kills [brown dog ticks], [American dog ticks,] [and lone star ticks] [and deer ticks] 

[(Rhipicephalus sanguineus)] [for up to [4 weeks] [1 month] [30 days]] 

[Kills American Dog Ticks [(Dermacentor variabilis)] for up to [4 weeks] [I month] [30 days]!] 

{Flea Eggs and Larvae( 

[Controls [flea] reinfestation [for upto [12 weeks] [3 months]]] 

[Kills adult fleas, flea eggs flea larvae and prevents pupae for up to [three months] [12 weeks].] 

[Effectively protects against all stages of the flea (including adult fleas, flea eggs, flea larvae 

and prevents f1 ea pupae)] 

[If dog is a high risk for flea reinfestation a once month application may be needed] 

[Prevents from developing, flea eggs Darvae] [pupae] for up to [3 months] [12 weeks]] 

[With (S)-methoprene Insect Growth Regulator [IGR] which Breaks the Flea Life Cycle] 

[With (S)-methoprene to Break Flea Life Cycle] 

[With Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

[Dual Action [!]:Fipronil with (S)-methoprene IGR [insect growth regulator] Effectively Breaks 

the Flea Life Cycle] 

[Dual Action I!]: Effectively Breaks the Flea Life Cycle [ill 

[Kills Flea Eggs & Flea Larvae for [3 months] [12 weeks]!] 

[Prevents Flea Eggs From Developing Into Biting Adults] 

[Prevents all stages of the flea life cycle from developing] 

[Controls reinfestation [for up to 3 months]] 

[Effectively protects against all stages of the flea life cycle] 

[All Others] 

[For Dogs and Puppies 8 weeks of age or older] 

[Controls mites that may cause sarcoptic mange] 

[For Dogs [up to 22Ibs.], [23-44Ibs.], [45-88Ibs.], [89-132Ibs.( 

[Fast Acting( [Long Lasting] 
28

Sergeant's Master Label 

19 January 201 1 Amendment Version 10.2 EPANo.2517~134 

Infonnation in 1 I is optional. Page 3 of9 EPA SAL 4 Nov 2010 

FRONT PANEL DOG SQUEEZE ON 

[Prevents reinfestation of listed pests for [4 weeks] [1 month]] 

[Easy to use [application]] 

[Once month treatment recommended] 

[A once monthly application is recommended for chewing lice] 

[Rapid elimination of chewing lice infestations] 

FIPRONIL+ METHOPRENE 

[[Three] 13] Applications] and/or [3 Month Supply] or [12 Week Supply] 

[Best if used year round!] 

I(ICON Showing 14 week] [1 month] [30 day] Protection)] 

14 Week Dose'] II Month Dose'] [30 Day Dose!] 

[Specially Fonnulated for Dogs and Puppies 8 weeks of age or older] 

[[Free] Calendar Stickers Inside!] 

[Apply once every [4 weeks] [month] 130 days]!] 

IWaterproof] 

[Can be used on breeding, pregnant and lactating [bitches] [female]ldogs]] 

[[Free with purchase] [Free inside] Monthly Application Reminder IMagnet]linside]] 

[Can be used on puppies 8 weeks of age and older] 

[Fipronil (9.8%) + (S)-methoprene (8.8%)] 

[Lift [here] for more infonnation] 

[Contains Fipronil and (S)-methoprene[,] [-] the active ingredients used in Frontline Plus®*] 

[*[Brand name] is not manufactured by or distributed by Merial. Frontline Plus® is a 

registered trademark of Merial.] 

[U.S. Patent No. 5,567,429] 

[[3] applications] 

[For year-roW1d protection, apply [Brand name] monthly] 

[Effective after bathing and exposure to water and sunlight] 

[Stops and prevents infestation oflisted pests for [4 weeks][l month]] 

[Stops existing infestation and prevents establishment of additional infestation of listed pests] 
29

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in [ [is optional. Page 4 of9 EPA SAL 4 Nov 2010 

FRONT PANEL . ..' DOG SQUEEZE ON 

'.. . FIPRONIL+METHOPRENE 

[For use ONLY on dogs 

[Up to 22 lbs] 

[23-44 lbs] 

[45-88Ibs] 

[89-132Ibs] 

[over 8 weeks of age]] 

[For Dogs & Puppies 8 weeks or older and] [up to 22 Ibs.] 

[For Dogs 23-44 Ibs.] 

[For Dogs 45-88 Ibs.] 

[For Dogs 89-132 lbs.[ 

ACTIVE INGREDIENTS: 

Fipronil ........................................................................ 9.80% 

(S)-methoprene .......... n .',. 'n •••••••• " •••••••••••• , •• , ••••••••••••••• 8.800/0 

OTHER INGREDIENT**: .................................... 81.40% 

TOTAL 100.00% 

[**diethylene glycol monoethyl ether] 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See [Back][or][Side] [Label Panel[slJ [or] [insert] for Additional Precautionary Statements 

NET CONTENTS: 

{END - FRONT PANEL} 

[3] [three] 0.023 fl oz (0.67 mL) applicators 

[3] [three] 0.045 fl oz (1.34 mL) applicators 

[3] [three] 0.091 fl oz (2.68 mL) applicators 

[3] [three] 0.136 fl oz (4.02 mL) applicators 
30

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in I ] is optional. Page 5 of9 EPA SAL 4 Nov 2010 

BACK ISIDEPA,NEL .' '. '. ,DOGSQUEEZEON 

FIPRONIL+.METHOPRENE 

[[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (IGR) to effectively 

kill fleas and ticks [(including those that may transmit Lyme Disease).] [The active ingredients in 

[brand name] feature a sustained release formula developed for fast acting [and long lasting] 

control of fleas, ticks, mosquitoes and chewing lice for up to 30 days on dogs.] 

[Brand name] 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. 

PRECA UTIONARY STATEMENTS 

HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation. Avoid 

contact with skin, eyes or clothing. Wash hands thoroughly with soap and water after handling and 

before eating, drinking, chewing gum, using tobacco, or using the toilet. 

HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 8 

weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product. 

[Some dogs may experience temporary startle effects when any product is applied.] Dogs may 

experience some temporary irritation at the site of product application. If signs persist, or become 

more severe within a few days of application, consult a veterinarian immediately. If your dog has an 

unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain 

medications can interact with pesticides. Consult a veterinarian before using on medicated, 

debilitated Or aged dogs. Call 1 w800w 781-4738 for 24-hour assistance. 

FIRST AID 

If swallowed: Call a poison control center or a doctor immediately for treatment advice. 

Have person sip a glass of water ifable to swallow. Do not induce 

vomiting unless told to do so by a poison control center or doctor. Do not 

give anything by mouth to an unconscious person. 

If in eyes: Flush eyes with plenty of water. Call a doctor if irritation persists. 

If on skin: Wash with plenty of soap and water. Get medical attention if irritatiOlt, .. 

persists. - - ---

HOTLINE NUMBER - Have the product container or label with you when calling a poison control cel1tf!r9r doc1or, or 

going for treatment You may also contact 1-800w781w4738 for emergency medicd'treatment 

information. ' .. 
31

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in I I is optional. Page 6 of9 EPA SAL 4 Nov 2010 

BACK/SIDE PANEL DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU 

AND YOUR DOG, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH 

USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. 

FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON 

OTHER ANIMALS. 

Do not use on puppies under 8 weeks of age. [Do not split one tube between dogs.] [Do not use 

multiple tubes on one dog.] Weigh your dog to be sure you are applying the right dose formulated 

for the weight of your dog. Consult a veterinarian before using this product on debilitated, aged, or 

medicated dogs. Can be used on breeding, pregnant, or lactating dogs. Consult a veterinarian 

before using on dogs with known organ dysfunction. Dogs may experience some temporary 

irritation at the site of product application. Certain medications can interact with pesticides. 

Sensitivities may occur after using ANY pesticide product on dogs. If signs of sensitivity occur 

bathe your dog with a mild soap and rinse with large amounts of water. If signs continue, consult a 

veterinarian immediately. 

{Outer Packaging} 

How to open: Remove product tubes [vial] from the package. Separate one tube from the others. 

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the 

narrow end at the notches with scissors. 

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to 

apply all of the solution to the dog's skin, as directed below. Do not apply more often than once 

every 4 weeks. 

[Optional drawings that mayor may not appear on finished label] 

FREQUENCY OF APPLICATION 

Use [brand name] monthly for complete control of flea, tick [and] chewing lice [and mosquito] 

infestations. [Studies show that] [brand name] kills adult fleas for up to three months. Apply 

monthly if your dog is at high risk for flea reinfestation [, or in a highly infested environment~. 

Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] remains effeC'd Ve, 

even after bathing, water immersion, or exposure to sunlight. Allow treated area to dry thGr~"'J.gl:ly. 

Do not reapply for 30 days. 

For Dogs Weighing up to 22 lbs. [including small dogs and puppies, 8 weeks u'r older]: 

{For cartons containing 0.67 mL (0.023 fl oz) applicator tubes} 

Apply one tube (0.67 mL)(O.023 fl oz) [from the back of the neck to a point midv.!.lj between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 
32

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in I I is optional. Page 7 of9 EPA SAL 4 Nov 2010 

BACK ISIDE PANEL DOG SQUEEZE ON 

FIPRONIL+ME'j'HOPRENE 

For Dogs Weighing 23 - 441bs. 

{For cartons containing 1.34 mL (0.045 fl oz) applicator tube} 

Apply one tube (1.34 ml)(0.045 fl. oz.) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 45 - 881bs. 

{For cartons containing 2.68 mL (0.091 fl oz) applicator tube} 

Apply one tube (2.68 ml)(0.091 fl. oz.) [from the back of the neck to a point midway between the 

neck and taiL] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 89 - 132 Ibs. 

{For cartons containing 4.02 mL (0.136 11 oz) applicator tube} 

Apply one tube (4.02 ml)(0.136 fl. oz.) Ifrom the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool 

(below 77°F [25°C]) dry place inaccessible to children and pets. Do not refrigerate. Protect from 

direct sunlight. 

CONTAINER DISPOSAL: If empty: Non~refillable container. Do not reuse or refill this 

container. Offer for recycling if available. If partly filled: Call your local solid waste agency for 

disposal instructions. Never place unused product down any indoor or outdoor drain. 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this product, 

user or buyer accepts the following warranty. [[The directions for use of this product are believed 

to adequate and must be followed carefully. It is impossible to eliminate all risks associated with 

the use of this product. Unintended consequences may result because of unknown factors. All such 

risks shall be assumed by the user or buyer.J] Sergeant's is committed to providing high quality 

products. To the extent consistent with applicable law, Sergeant's makes no waHanties, express or 

implied, of merchantability or of fitness for a particular purpose or otherwise, that extend beyond 

statements on this label. To the extent consistent with applicable law, Sergeant's, the manuf3::urer, 

or the Seller shall not be liable for indirect, special, incidental or consequential damages. Tu ttle 

extent consistent with applicable law, the exclusive remedy of the user or buyer shall not e;~..:;(!cd the 

purchase price paid.] 

[If you have questions or comments about this product, please write: [Sergeant;s]' [SENTRY] 

Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.] 

In Case of Emergency, caU: 1-800-781-4738 

Non-Emergency, call: 1-800-224-PETS (7387) 

[Coupon(s) inside or on outside ofbo'<] 

[Made in USA 1 
33

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in [ ] is optional. Page 8 of 9 EPA SAL 4 Nov 20 I 0 

BACK ISIDE PANEL DOG SQUEEZE ON 

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-134 

EPA Est. No. 2517-TN-I [XXXXX-XX-XXX] 

{END - HACKl SIDE PANEL} 

FIPRONIL+METHOPRENE 

[BAR CODE AREA] 

U.S. Patent No. 5,567,429 

OUTER PACKAGING OR INSERT COPY "'DOG SQUEEZE ON 

FIPR()NIL+ METHOPRENE 

[How to Apply - May contain graphics illustrating product usc, e.g., dog with a drop falling 

onto its neck from a vial on front, side, or back carton label and/or applicator labeling.] 

lAppIication Instructions] [Directions for Use] 

How to open 

1. Remove product tubes [vial} from the package. 

2. Separate one tube from the others. Holding the tube {vial} with notched end pointing up and 

away from the face and body, cut off the narrow end at the notches with scissors. 

How to apply [Optional drawings that mayor may not appear on finished label] 

1. Invert tube over dog and use open end to part dog's hair. 

2. Squeeze tube firmly to apply all of the solution to the dog's skin [as a spot to the dog's back 

between the shoulder blades.] [or] [from the back of the neck to a point midway between the 

neck and tail.] 

[Flea life cycle diagram] [Flea Life Cyele] 

[Sample coloring and layout may 

be different on finallabelJ 

[Look at the Label (Look at tile Label icon) [Easy] 

6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Chccklist] 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use dog products on cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 
34

Sergeant's Master Label 

19 January 2011 Amendment Version 10.2 EPA No. 2517-134 

Information in [ ] is optional. Page 9 of9 EPA SAL 4 Nov 2010 

OUTER PACKAGING OR INSERT. COPY DOG SQUEEZE ON , " " " ' '--., , "'" , " 

[Brand name] 

[3] [Month [Treatment] [Application] Tracker] 

[For year-round protection, apply [Brand name] monthly.] 

[Pet's Name (Empty blank for owner to fill in name)] 

[First] [I st] [Second] [2nd] [Third] [3rd] 

FIPRONIL+M.ETHOPRENE 

[Dose] [Treatment] [Application](Empty blank for owner to lilI in date)(Date: MM/DDIYY)] 

[calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply 

[brand name] in 30 days.] 

[Monthly Application Reminder Magnet (image of reminder magnet)] 

[Enclosed for your convenience is an application reminder magnet. Push the (reset) button, and the 

reminder light wiJ1 blink twice. The reminder tag is now set for 30 days. At the end of 30 days the 

reminder light will blink, reminding you to reapply [Brand name]. Press the button once and the 

blinking light will stop. Press the button again and this will reset the timer for another 30 days.] 

@ Adulf~' 

~ Adult Flea ~ filaEg<jS 

... Rea Eggs e§J fila l""" 

.., Rea larvae S f",Pupae 

- Rea f'l4>ae @ Erovm Dog Ti~k 

"" Brown Dog TICk @ LoneStarTlCk 

.,. Lone Star T tel< ® Oeff Tick 

"" Deer Tick @ Arntt~aIlDoq id ,,t 

, Arnerican Dog TICk 

@ CIYJIMng Lice '" O1eoNing Lice 

~, Mosquito ~ Mosquito 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

TUBE/VIAL LABEL DOG SQUEEZE ON 

FIPRONIL.,.METHOPRENE 

Front Label 

{Brand Name}fcat graphic with line through] 

For dogs [up to Xj[X-Yjlbs 

FiproniI 9.8% w/w, (S)-methoprene 8.8% w/w 

0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL 

{label code I 

[END - TUBENIAL COPY} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions before 

1lsing. Use scissors to open. 

EPA REG. No. 2517-134 (label code) 
35
36
37

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 22, 2010 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Sergeant's Pet Care Products, Inc., c/o Exponent 

Mr. James Messina 

1150 Connecticut Avenue, NW Suite 1100 

Washington, D.C. 20036 

Subject: Agency-initiated Required Label Amendment 

Sergeant's Fipronil + Methoprene Dog Squeeze On, EPA Reg. No. 2517-134 

Dear Mr. Messina: 

During a recent review of the Sergeant's Fipronil + Methoprene Dog Squeeze On product, 

EPA Reg. No. 2517-134, the Agency detenllined that certain pest efficacy claims are 

unacceptable and must be removed fro111 the label. To date, there is no acceptable data on file to 

support any pest repellency, kills pupae claim, and other certain or unqualified efficacy claims. 

Therefore, the struck-out text must be deleted from the label and the bolded text must be added 

as described below: 

Page 2: 

[Mosquitoes] 

[Kills mosquitoes] [within 24 hours] 

[Kills ([and] [&] repels) mos~Hitoes that may transmit heartwonn] 

[Adult Fleas] 

[Kills [adult] fleas [for up to three months.] 

[Kills newly emerged adult Fleas before they lay eggs] 

[Kills [and Fcpels] Fleas, source of [flea allergy dennatitis] [, flea bit anemia] [and 

tapewonn infestations]] 

[Kills [&] [aIld] [Repels] Fleas Up to [4 weeks] [I month] [30 days]!] 

[If dog is at high risk for flea reinfestation a once a month application may be needed] 

Multiple Infestations 

[Kills fchewingllice and controls mites that may cause sarcoptic mange] 

[Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] 

[Kills [aIld] [&] repels] fleas, flea eggs, ticks, fchewing:l-lice [&] [and] mosquitoes] 

[Kills [and] [&] [repels] fleas, ticks, mosquitoes, fchewingJlice, flea eggs, and flea 

larvae 

[&] [aHd] [flea pupae] 

[Kills [&] [and] [Repels] Fleas, Ticks [&] [and] Mosquitoes] 

Page I of3 
38

[Monthly flea, tick, mosquito, chewing lice, and flea egg protection] 

[Monthly flea, tick, mosquito and chewing lice protection] 

Page 3: 

[Ticks] 

[Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice] 

[ [Seven3 [73 Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae 

[&] [aad] flea ~llflaell 

[6 [Six] Way Protection~ to Kills fleas, ticks, mosquitoes, chewing lice, flea eggs [&] 

[and] flea larvae] 

[[Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Chewing Lice Control] 

[Kills [&] [and] Re~els Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I 

month] [30 days]'] 

[Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [1 month] [30 days]] 

[Images of the different kinds of bugs killed with a line drawn through each bug]] 

[Kills [and3 [&3 repels] Ticks including those that may transmit Lyme disease] 

[Kills [and] [&] re~els] Ticks for Up to [4 weeks] [1 month] [30 days]!] 

[[Kills [and R"J'els] [all stages ofJ (deer) ticks [before they can] [that] [transmit Lyme 

disease,] [for up to [4 weeks] [1 month] [30 days] [per application]]] 

[Kills [aad] [&] repels] Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] [30 

days]] 

[Kills [and] [&] re~els] [brown dog ticks,] [American dog ticks,] [and lone star ticks] 

[and deer ticks] [(Rhipicephalus sanguineus)] [for up to [4 weeks] [1 month] [30 days]] 

[Kills [&] [and] Repels] American Dog Ticks [(Dermacentor variabilis)] for up to [4 

weeks] [1 month] [30 days]!] 

[Flea Eggs and Larvae] 

Page 4: 

[Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] 

[Kills adult fleas, flea eggs, and flea larvae and pupae for up to [three months] [12 

weeks].] 

[Kills all stages of the flea (including adult fleas, flea eggs, flea larvae and flea pupae)] 

[If dog is a high risk for flea reinfestation a once month application may be needed] 

[Kills flea eggs [larvae] [pHpae] for up to [3 months] [12 weeks]] 

[Kills all stages o[the flea life eycle] 

[Complete protection against all stages of the flea life cycle] 

[All Others] 

[Dogs can be bathed 24 hours after treatment] 

[Prevents reinfestation] 

[Fast Action against [chewing] lice infestations] 

[Dogs can be ba-thed 24 hours after Spot on is applied] 

Page 2 of3 
39

Page 6: 

[[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (lOR) to effectively 

kill [and repel] fleas (all stages) and ticks [(including those that may transmit Lyme Disease)]. 

Within 30 calendar days from the date of this letter, you must respond by submitting 

updated draft labels that addresses the comments above, as well as incorporating the comments 

from the November 4, 2010 Notice of Registration. If these conditions are not complied with, 

the registration will be subject to cancellation in accordance with FIFRA Section 6(e). lfyou 

have any questions concerning this action, you may contact Rosanna Louie-luzwiak at 703-308-

0037 or email her at louie-juzwiak.rosanna@epa.gov. 

-\'. <" 

~~&:-L Richard Gebken 

Product Manager 10, Insecticides Branch 

Registration Division 

Page 3 of3 
40
41

Karen C, Cunningham, DVM, DABVP 

Head, Regulatory Affairs 

Lifecycle Management US 

Merlal Limited 

Tel: 678-638-3138 

Fax: 678-638-3707 

December 17, 2010 

Richard Gebken, Product Manager 10 

Registration Division 

Office of Pesticide Programs (7505P) 

U.S, Environmental Protection Agency 

Room 5-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202-4501 

SUBJECT: Sergeant's Pet Care Products, Inc" EPA Reg. No. 2517-134 

Dear Mr. Gebken: 

3239 Satellite Blvd 

Duluth, GA 30096 

Tel: 678.638.3000 

Merial submits this letter as a follow-up to our telephone conversation on December 3, 

2010 regarding Sergeant's Pet Care Products, Inc., EPA Reg. No. 2517-134 (Sergeant's 

Fipronil + Methoprene Squeeze-On for Dogs),The purpose of Merial's call was to 

understand some of the claims listed in the newly approved labeling for the 

aforementioned Sergeant's product, including claims of repellency. You indicated that 

Sergeant's cited Merial data to support the registration of this product. I painted out that 

repellency is not consistent with the known mode of action of fipronil and none of 

Merial's fipronil-based products have repellency claims. We also discussed the fact that 

Frontline Plus does not kill flea pupae, yet the Sergeant's label includes claims such as 

"kills flea pupae" and "kills all stages of the flea," You committed to following up with the 

EPA entomologists and suggested that Merial submit a formal challenge to the 

Sergeant's label. To that end, please find in Attachment 1 a table highlighting Merial's 

specific objections to claims in the Sergeant's Fipronil + Methoprene Squeeze-On for 

Dogs labeling dated November 4, 2010, 

Merial respectfully requests a complete and thorough review of the label for the me-too 

product Sergeant's Fipronil + Methoprene Squeeze-on for Dogs (EPA Reg. No. 2517-134) 

to ensure that all label claims comport with the label for Frontline® Plus for Dogs (EPA 

Reg, No, 65531-5). Merial believes that the Sergeant's product labeling approved 

November 4, 2010 would give Sergeant's an unfair competitive advantage if it were 

distributed, Merial requests that appropriate regulatory action be taken quickly to 

prevent distribution or sale of the product with this labeling and to ensure that the label 

is revised prior to consideration by the States. 

If you have any questions or require additional information, please contact rT)t;! py 

telephone at 678-638-3138 or email at karen.cunningham@meriaLcom, 

Sincerely, _ ~' 

"-'~e~ 

.~~~/~ Cunningham, DVM, DABVP 

Head, Regulatory Affairs Lifecycle Mgmt US 

Merial Limited 

M .. riallimit .. d is thE AnimO!I HEO!lth subsidiary of s1Inofi-av"-ntis 

A campanyumiled by shares I'1!gi!tel'1!d in EIlgIand ~nd Wiles Il'1!gillend nwnoor 3J3r1511 wilha f1igi!tef1id offiCI! at PII Box 3rI 

Sllndringham HOlm. SandringhamAv!fJIle. Hallow Bminess Pir\(. Harlow. Essex CMI9 5Q4. England. iIld dame!ticalotl in DulaWin!. USA is MerialllC 
42

Attachment 1 

Table highlighting Merial's specific objections to claims In the Sergeant's 

Fipronil + Methoprene Squeeze-On for Dogs labeling dated November 4, 2010 
43

Page Section Label Claim Rationale 

# (objectional portion highlighted) 

2 Mosquitoes [Kills mosquitoes] [within 24 hours] Based on the efficacy review (MRID 

45866902), mosquito labeling language 

for Frontline Plus for Dogs reads: 

"Kills mosquitoes within 24 hours for up 

to 7 days and within 48 hours for up to 

28 days." 

2 Mosquitoes [Kills ([andJ [&J repels) mosquitoes Repellency is not consistent with the 

that may transmit heartworm] known mode of action of fipronil and 

none of Merial's fipronil-based products 

have repellency claims. 

2 Adult Fleas [Kills [and repels] Fleas, source of Repellency is not consistent with the 

[flea allergy dermatitis] [, flea bite known mode of action of fipronil and 

anemia] [and tapeworm none of Merial's fipronil-based products 

infestations]] have repellency claims. 

2 Adult Fleas [Kills [&J [andJ Repels Fleas Up to [4 Repellency is not consistent with the 

weeksJ [1 monthJ [30 daysJ!J known mode of action of fipronil and 

none of Merial's fipronil-based products 

have repellency claims. 

2 Multiple Bugs [Kills [andJ [&J [repelsJ fieas, flea Repellency is not consistent with the 

eggs, ticks, [chewingJ lice [&J [andJ known mode of action of fipronil and 

mosquitoes] none of Merial's fipronil-based products 

have repellency claims. 

2 Multiple Bugs [I@J~ ([andJ [&J [repelsJ fieas, ticks, Repellency is not consistent with the 

mosquitoes, [chewing] lice, flea known mode of action of fipronil and 

eggs, flea larvae [&J [andJ tij~~ none of Merial's fipronil-based products 

[l.lpifeJ have repellency claims. 

"Kills ... f1ea pupae" does not comport with 

the Frontline Plus label 

2 Multiple Bugs [Kills [andJ [&J [RepelsJ Fleas, Ticks, Repellency is not conSistent with the 

[&] [and] Mosquitoes known mode of action of fipronil and 

none of Merial's fipronil-based products 

have repellency claims. 

3 Multiple [SevenJ [7J Way Protection r~HI.~ "Kills ... f1ea pupae" does not comport with 

Infestations fleas, ticks, mosquitoes, lice, flea the Frontline Plus label 

eggs, flea larvae [&] [and] f(~'S 

pUpae 

3 Multiple Bugs [Kills [&J [andJ Repels Fleas and Repellency is not consistent with the 

Ticks for up to [4 weeks] [1 month] known mode of action of fipronil and 

[30 daysJ!J none of Merial's fipronil-based products 

have repellency claims. 

3 Ticks [Kills [andJ [&J [repelsJ Ticks Repellency is not consistent with the 

including those that may transmit known mode of action of fipronil and 

Lyme disease] none of Merial's fipronil-based products 

have reDellencv claims. 

1 of 2 
44

Page Section Label Claim Rationale 

# (ob;ectional Dortion hiahliahtedl 

3 Ticks [Kills [and] [&] [repels] Ticks [for Up Repellency is not consistent with the 

to] [4 weeks] [1 month] [30 days]!] known mode of action of fipronil and 

none of Merial's fipronil-based products 

have repellency claims. 

3 Ticks [Kills [and] [&] [repels] [all stages Repellency is not consistent with the 

of] deer ticks [before they can] known mode of action of fipronil and 

[that] [transmit Lyme Disease,] [for none of Merial's fipronil-based products 

! ~~, to [4 weeks;N month] [30 days] 

er aDolication 

have repellency claims. 

3 Ticks [Kills [and] [&] [repels] Ticks Repellency is not consistent with the 

(Including Deer Ticks) for up to [4 known mode of action of fipronil and 

weeks] [1 month] [30 days]] none of Merial's fipronil-based products 

have repellency claims. 

3 Ticks [Kills [and] [&] [repels] [brown dog Repellency is not consistent with the 

ticks], [American dog ticks.] [and known mode of action of fipronil and 

lone star ticks] [(Rhipicephalus none of Merial's fipronil-based products 

sanguineus)] [for up to [4 weeks] [1 have repellency claims. 

month] [30 days]]] 

3 Ticks [Kills [&] [and] [Repels] American Repellency is not consistent with the 

Dog Ticks [(Dermacentor variabilis)) known mode of action of fipronil and 

for up to [4 weeks] [1 month] [30 none of Merial's fipronil-based products 

days]!] have repellency claims. 

3 Flea Eggs and r~lIr~ adult fleas, flea eggs, flea "Kills ... f1ea pupae" does not comport with 

Larvae larvae and pbj)~\~ for up to [three the Frontline Plus label 

months] [12 weeks].] 

3 Flea Eggs and iJl:jll[£~m~lf:ge~K<:if£~l1:eLlle~ (i ncl uding "Kills all stages of the flea" and 

Larvae adult fleas, flea eggs, flea larvae and "Kills ... f1ea pupae" do not comport with 

llei4"u"'"e)] pp the Frontline Plus label 

3 Flea Eggs and mUll/I''' ' "",,5.j,,&!.?1 eggs [I arvae ] r~'N"'l 'PJl_R~t~, f or "Kills f1ea ... pupae" does not comport with 

Larvae up to [3 months] [12 weeks]] the Frontline Plus label 

4 Flea Eggs and [15U1~jJiiJlr~~'iies of the fiea life cycle] "Kills all stages" does not comport with 

Larvae the Frontline Plus label 

4 Flea Eggs and [Cioilr~ete:"fdtection~a"arns!tall "Complete protection against all stages" 

Larvae $I~;G~~Z9f{t[e:~ij~~:iti,~,~~~f~" _m_'" does not comport with the Frontline Plus 

label 

6 BACK PANEL [[brand name] contains Fipronil and Repellency is not consistent with the 

S-Methoprene (insect growth known mode of action of fipronil and 

regulator) (IGR) to effectively k!1J none of Merial's fipronil-based products 

[and repel]lIe:al>iCam~g:e~j and have repellency claims. 

ticks [(including those that may 

transmit Lyme Disease)]. "Kill...fleas (all stages)" does not 

comoort with the Frontline Plus label 

2 of 2 
45

Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130~1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 

November 23, 2010 

Rosanna Louie~Juzwiak 

Document Processing Desk 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Room SA900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202-4501 

Subject: 

Sergeant's 

Response to 

Fipronil 

EPA Notice 

+ S-Methoprene 

of Registration 

Squeeze~on 

for 

for DogS:(2.2 

~ 

.. !7-LL4}) 

Dear Ms. Louie-Juzwiak: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 1581h Plaza, Omaha, NE 68130-1770, 

EPA Company Number 2517) is submitting a response to EPA's Notice of Registration dated 

November 4, 2010 for Sergeant's Fipronil + S~Methoprene Squeeze-On for Dogs (EPA Registration 

Number 2517-134). Please find enclosed the following support documents: 

• 8570-1 fonn; 

• A copy of the offer to pay letter dated December 21,2009 to Merial Limited and delivery 

confirmation; 

• A copy of the FedEx tracking receipt (8673 4197 3765) and delivery confirmation; and 

• A copy of response correspondence from Merial Limited acknowledging receipt (dated 

March 3, 2010). 

Sergeant's is responding to the following requests made by the Agency: 

1. You must provide the Agency with a projected release for shipment date within 30 days of 

the date of this Notice of Registration. The Agency will calculate the expiration date based on 

the projected release for shipment date until an actual release for shipment date is provided in 

writing. 

a. Sergeant's projects the anticipated release for shipment date to be March 1,2011. 

2. Within 30 days from the date of this registration, in accordance with F1FRA §3(c)(1)(F) and 

3(c)(2)(B), you must submit a copy of all offers to pay compensation and evidence of their 

delivery, used to support the data required for this product. 

a. Please find enclosed a copy of the offer to pay letter to Merial Limited and delivery 

confirmation. 
46

Sergeant's Pet Care Products, Inc. 

2625 Soutl1158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • W1Nw.sergeants,com 

Ifyotl have any questions, please contact me at 402-938-7079. 

STil' / / /J' ~ lUuj lI15X--/1 __ 

Kelly Hoskins 

Manager of Technical Affairs 

Sergeant's Pet Care Products, Inc. 

Enclosures 

cc: Richard Gebken, EPA 
47

PI ease read' rns t rue 1'0 r ns on reverse b " re c .0 feting" 0=. Form A p prove , .....,8 No 2070 0060 Approval expires 05-31 98 , , 

United States [lRegistration opp Identifier Number 

EPA Environmental Protection Agency D,Amendment 

Washington, DC 20460 [g] Other 

Application for Pesticide w Section I 

1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 

2517-134 Richard Gebken 

4. Company/Product (Name) PM#10 ~"Jone DRestncted 

Sergeant's Pet Care Products, Inc. / Sergeanl's Fipronil + S-mcthoprenc 

Squeeze-On For Dogs . 

5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA 51>6[0'n '3\ c )(3)(b)(l), my 

Sergeant's Pet Care Products, Inc. product is similar or identical in compositio,n and labeling IQ: 

2625 South lS8th Plaza 

Omaha, NE 68130-1770 EPA Reg. No. . 

Product Name 

D Check if this is a new address 

Section II 

D Amendment - Explain below. D Final printed labels in response to Agency letter u~I~;I xx·xx-xx 

o Resubmission in response to Agency leiter dated 11f4f2010 D "Me Too" Application 

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

Explanation: Use additional page(s) if necessary, (For section I and Section 11.) 

Submission of a response to EPA Notice of Registration conditional requirements. 

Section III 

1. Material This Product Will Be Packaaed In: 

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

[g] Yes* 0yes DYes DMetal 

DNo D No ISJ No [gj Plaslic 

If ''Yes'' No. per If "Yes' No. per DGlaSS 

"Certification must Unit Packaging wgt. Container Package wgt. Container 

DPaper be submitted 0.023 11 oz (0.50 ml) 3 vials 

0.045 tloz(I.34ml) I I DOther (Specify) Plastic Bag 0.091 11 oz (2,68 ml) 

0.13611 oz (4.02 ml) 

3 Location 0/ Net Contents Information 4. Size(s) Retail Container 5. Location of Label Directions 

[glLabel D Container 0.023 11 oz (0.50 ml). 0.045 11 oz (1.34 ml), 0,091 11 

oz (2.68 ml), 0.136 11 oz (4.02 ml) 

DOn Can 

~On Labeling accompanying product 

6. Manner in Which Label is Affixed to Product b:!UthOgraPh IZlOther 

DPaper glued 

DStenciled 

Section IV 

1. Contact Point (Comptete items direc/IY below lor identification of individuat to be contacted, if necessery, to process this applica/ion.) 

Name Title Telephone No. (Include Area Code) 

Kelly R. I-Ioskins Managcr of Technic a! Affairs 402-938-7079 

Certification 6. Date Application 

I certify that the statements I have made on this torm and all altachments thereto are true, accurate and complete. I Received 

acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) 

under aoolicable law. 

2.Si'OU jL/~h 3. Title . , 

BY, ' c;i Manager of Technical Affairs 

4. Typed Name: I Kelly R. Hoskins 5. Date: 1112312010 
48

Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

U.S. Registered Mail 

December 21, 2009 

Merial Limited 

3239 Satellite Blvd., Bldg 500 LOC 106B 

Duluth, GA 30096 

Subject: Offer to Pay Compensation Under FIFRA Section 3(c)(l)(F) 

Sergeant's Pet Care Products, Inc. Proposed Product Sergeant's Fipror:iJ + 

S-methoprene Squeeze-On for Dogs ("Product") 

To Whom It May Concern: 

As required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 

3(c)(l)(F), and implementing regulations at 40 CFR Part 152 Subpart E, Sergeant's Pet Care 

Products, Inc. ("Sergeant's") hereby notifies Merial Limited, EPA Company Number 65331 

("COMPANY") that it intends to cite data regarding fipronil andlor (S)-methoprene on file with 

the U.S. Environmental Protection Agency ("USEPA" or "Agency") related to your end-use 

products containing fipronil andlor (S)·methoprel1e to support the USEPA registration of an 

end-use Product containing the same active ingredients. 

According to the USEPA's Listing of Pesticide Data Submitters (dated September 30, 

2009), Sergeant's has identified COMPANY as an Original Data Submitter who has end-use 

product data on file with the Agency for the active ingredients fipronil andlor (S)-methoprene. 

Sergeant's hereby notifies COMPANY: 

1. that it is the intent of Sergeant's to submit to the USEPA an application for pesticide 

registration for the Product containing the active ingredients fipronil and (S)-

methoprene; 

2. that Sergeant's offers to pay compensation regarding data, as appropriate, to 

COMPANY, with regard to the approval of this registration application, to the extent 

required by FIFRA Section 3(c)(l)(F); and 

3. Sergeant's offers to commence negotiations to determine the amount and tenns of 

compensation, if any, to be paid for the use of any data. 

If COMPANY intends to request compensation for the use of COMPANY's data, with 

regard to the approval of Sergeant's registration application, Sergeant's respectfully requests 
49

Page 2 

that COMPANY indicate, by return correspondence, the amount and terms of such requested 

compensation and the following information for each Study for which cC?I11--rensation is 

requested: 

1. the MRlD number, 

2. the Study Title, 

3. the date of Study submission, and 

4. the amount of any compensation previously received by COMPANY forthe use of 

these data from other parties. 

Sergeant's requests a response from CO:MPANY "vithin 90 days from the date of this 

letter. If Sergeant's does not receive a response within 90 days, it will understand that no data 

compensation is requested by COMPANY. 

If you have any questions, please contact me at 402-938-7079. 

Kelly Hoskins 

Manager of Technical Mfairs 

Sergeant's Pet Care Products, Inc. 

cc: Larry Nouvel, Sergeant's Pet Care Products, Inc. 
50

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RETAIN THIS con FOR YOUR RECORDS, 
51

Page 1 of 1 

@ Print page Close €2J 

Detailed Results 

Tracking no.: 867341973765 Select time format 12H 

Delivered Delivered 

Signed for by: J.SMARR 

Shipment Oales Deslinalion 

Ship date Dec 21, 2009 DULUTH, GA 

Delivery date Dec 22, 2009 10:04 AM Signature Proof of Delivery 

Shipment Options 

Hold at FedEx Location 

Hold at FedEx Location service is not available for this shipment. 

Shipment Facts 

Service type Standard Overnight 

Shipment Travel H islory 

Select time zone: Local Scan Time 

All shipment travel aclivily is displayed in local time for the location 

DatelTima Activity Location Details 

Dec 22, 200910:04 AM Delivered OULUTH,GA 

http://www.fedex.com/TrackinglDetaiI7ftc_start _ url~&totalPieceNum~&backTo~&template _ ty... 11/23/2010 
52

~lllsDur~ Pillsbury Winthrop Shaw Pittman LLP 

2300 N Street, t#'J ! Washington, DC 20037-1122 I Ie! 202.663.8000 I fax 202.663.8007 

March 3, 2010 

By Federal Express 

Ms. Kelly Hoskins 

Manager, Technical Affairs 

Sergeant's Pet Care Products, Inc. 

2625 South 158ili Plaza 

Omaha, NE 68130-1770 

Warren U. Lehrenbaum 

leI 202.663.8754 

warren.lehrenbaum@Pillsburylaw.com 

Re: Demand for Compensation Under Section 3(c)(J)(F) of the Federal 

Insecticide, Fungicide, and Rodenticide Act (UFIFRA"). 

Dear Ms, Hoskins: 

I am writing on behalf ofMerial Limited ("Merial"), in response to your letters dated 

December 21,2009 (which we received on January 29, 2010). In those letters, you 

state that Sergeant's Pet Care Products, Inc. ("Sergeant's") offers to pay 

compensation to Merial pursuant to FIFRA §3(c )(1 )(F). for the use of Merial' s data 

on file with Environmental Protection Agency ("EPA"). 

We understand from your letters that Sergeant's has applied to EPA to register four 

end-use pest control products that are intended for use on dogs and cats. The four 

products are identified in your letters as follows: (i) Sergeant's Fipronil + Smethoprene Squeeze-on for Dogs; (ii) Sergeant's Fipronil + S-methoprene Spot-on 

for Cats; (iii) Sergeant's Fipronil'Only Squeeze-on for Dogs; and (iv) Sergeant's 

Fipronil Only Spot On for Cats. According to your letters, these products contain 

either fipronil only or fipronil plus s-methoprene as the active ingredients. Your 

letters indicate, further, that Sergeant's is only citing data pertaining to Merial's enduse products that contain fipronil or fipronil plus methoprene. 

Merial is prepared to enter into good faith negotiations aimed at reaching 'ag"etr.'1ent 

on the reasonable compensation that is owed to Merial by Sergeant's. In order to 

facilitate this effort, and to detennine what constitutes reasonable compensa,;j'on for 

the data at issue, we request that you provide us with the following items of 

www.pllisburylaw.com 40173t680v1 
53

March 3, 2010 

Ms. Kelly Hoskins 

Page 2 

infonnation for each of the four Sergeant's products that are the subject afyaur 

letters: 

• A copy of the proposed product label(s) submitted with each 

registration application, as well as any proposed supplemental 

labeling for the products; 

• A copy of the data matrix Sergeant's included with each 

registration application, and any subsequent revisions; 

• A copy of the Fonnulators Exemption Statement (EPA Fonn 

570-27) and a copy of the Certification with Respect to Citation 

efData (EPA Penn 8570-34) that Sergeant's submitted with 

each of its registration applications; and 

• Infonnation regarding the date(s) on which Sergeant's 

applications for registration were filed with EPA and the 

current status of those applications (in particular, are the 

applications still pending or have the registrations already been 

granted). 

In addition, we request that you provide us with written confinnation that Sergeant's 

is relying on the fannulators exemption for its four product registrations, in lieu of 

citing or supplying generic safety data for fipronil or methoprene. If Sergeant's is not 

relying on the formulators exemption, please explain why Sergeant's is not citing any 

generic safety data for fipronil or methoprene in support of its four registrations. 

Also, please confinn that: (i) Sergeant's is not citing any product chemistry data in 

EPA's files (Le., the product chemistry data used to support Sergeant's products were 

submitted by Sergeant's); and (ii) Sergeant's has used the cite-all method to satisfy 

the remaining data requirements applicable to its products (other than generic safety 

data for fipronil), including product efficacy and/or acute toxicity. 

In order to facilitate the prompt resolution of this matter and to avoid unnecessary 

additional effort and expense, please provide us with this infonnation within 30 days 

of the date of this letter. 

"""-W.pillsburylaw.COffi 401731680v1 
54

March 3, 2010 

Ms. Kelly Hoskins 

Page 3 

If you have any questions regarding this letter please feel free to contact me at (202) 

663-8754. 

cc: Selina Barnett, Esq. 

Karen C. Cunningham 

www.pllisburylaw.com 

Sincer YO~' j L-----

~~ ( 

Warren U. ehrenbaurn 

Pillsbury Winthrop Shaw Pittman 

Counsel for Merial Limited 

40173168Ov1 
55

EXponent" 

Submission to US EPA Document Processing Desk 

Document Processing Desk 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Date: November 23,2010 

Company: Sergeant's Pet Care Products, Inc. 

Submission List: 

• Submission of response to EPA conditions of registration for 2517-134. 

Confirmation of receipt by US EPA Document Processing Desk 

ExponenJ 

1150 Connecticut Ave., NW 

Suite 1100 

Washinglon, DC 20036 

lciephone 202·293-5374 

facsimile 202-293-5377 

www.cxponclltcom 

/Ip?/!u </.: c6 

US EPA Document Processing Desk Date/Time 
56

EXponent" 

Submission to US EPA OPP Document Processing Desk 

Office o[Pesticide Programs (7502P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room s-4400, One Potomac Yard 

2777 South Crystal Dr. 

Arlington, VA 22202 

Date: November 23, 2010 

Exponent 

1150 Connecticut Ave., NW 

Suite 1100 

Washington, DC 20036 

telephone 202·293·5374 

facsimile 202-293-5377 

www.exponentcom 

Company: Sergeant's Pet Care Products, Inc. (EPA Company Number 2517) 

Submission List: 

• Submission of an updated CSF and Formulator's Exemption Statement for Sergeant's 

Fipronil + S-methoprene Squeeze-On for Dogs (EPA Registration Number 2517-134) 

Confirmation of receipt by US EPA OPP Document Processing 

1I(:J3i(O 

US EPA Document Processing Desk Date/Time