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

March 09, 2010

Karen Cunningham, DVM Head, Regulatory Affairs LCM Merial, Ltd. 3239 Satellite Blvd., Bld. 500 Duluth, GA 30096

Subject: Revised Child Resistant (CR) Packaging Wording

Frontline Top Spot for Cats: EPA Reg. No. 65331-2 Frontline Top Spot for Dogs: EPA Reg. No. 65331-3 Frontline Plus for Cats: EPA Reg. No. 65331-4 Frontline Plus for Dogs: EPA Reg. No. 65331-5

Submissions dated August 14 and December 11, 2009

Dear Dr. Cunningham:

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

The above referenced submissions, in connection with registrations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, are acceptable.

Please note that we have approved the amended labeling for each product, with the understanding that it is consistent with the Agency's previously stamped accepted labels. See enclosed copies of the stamped labels for your record. If you have any questions concerning this action please contact Dr. B.A. Akinlosotu at (703) 605-0653.

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Product~anager 10 Insecticide Branch Registration Division (7505P)

Enclosure

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ACCEPTED MAR 09 2010

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Under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, for the

pesticide registered under:

EPA. Reg. No: tP53.3J- Z-

Kills fleas, ticks, chewing & mosquitoes • Convenient spot treatment for

fast-acting, long-lasting control of fleas, ticks, chewing lice and mosquitoes

• Waterproof

For Cats & Kittens 8 weeks or older. ACTIVE INGREDIENTS flpronil..... . ............... 9.7% INERT INGREDIENTS ........ 90.3% TOTAL ............................ 1 00.0%

KEEP OUT OF REACH OF CHILDREN CAUTION Contains 3(6)-0.017 R oz (0.50 ml) applicators

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How to Apply

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FRONTLINE® Top Spot®

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1. To Remove Applicator Lift and remove the plastic tab to expose foil backing; then peel away the foil. Or use scissors to open.

2. To Open Applicator Hold upright and snap applicator tip away from face and body.

3. To Apply FRONTLINE"' Place applicator tip through animal's hair to the skin level between the shoulder blades. Squeeze applicator, applying entire contents in a single spot to the animal's skin.

Questions or Comments? Call: 1-800-660-1842

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FRONTLINE" For Cats & Kittens 8 weeks or older.

Top Spot® for cats

FRONTLINE provides convenient ond effective flea, tick, chewing lice and mosquito control for cats and kittens 8 weeks or older.

Fast-acting and long-lasting Prevents reinfestation Convenient to use Kills newly emerged adult fleas before they lay eggs Controls fleas whir:h may r:ause flea allergy dermatitis Kills all stages of brown dog tir:ks, Amerir:an dog tir:ks, lone star tir:ks and deer tir:ks (whir:h may r:arry Lyme disease) Kills mosquitoes Rapidly eliminates infestations with r:hewing Iir:e Can also be used on breeding, pregnant and ladating queens Waterproof

FRONTLINE contains the active ingredient fipronil that effectively targets fleas, ticks, chewing lice and mosquitoes. Fipronil collects in the oils of the skin and hair follicles, and continues to be released from hair follicles onto the skin and coat, resulting in long-lasting activity.

® Flee Adult

• Brown Dog Tick

• Lone Star Tick

(f) Deer Tick

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FRONTLINE TOP SPOT FOR CATS provides convenient and effective flea, tick, chewing lice and mosquito control for cats and kittens 8 weeks or older. Directions For Use It is a violation of Federal Low to use this product in a manner inconsistent with its labeling. Do nat allow children to apply product. TO PREVENT HARM TO YOU AND YOUR PET, READ ENTIRE LABEL AND ENCLOSED DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. USE ON CATS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. To kill fleas, all stages of brown dog ticks, American dog ticks, lone star ticks, deer ticks (which may corry Lyme disease), chewing lice and mosquitoes, apply to cats and kittens (8 weeks or older) as follows: Hold opplicotor upright and snap applicator tip away from face and body. Place applicator tip through animol's hair to the skin level between the shoulder blades. Squeeze applicator, applying entire contents in a Single spot to the animal's skin. Avoid superficial application to the animal's hair. Only one applicator per treatment is needed. FRONTLINE TOP SPOT FOR CATS can also be used for the treatment and control of mosquitoes, and flea, tick and chewing lice infestations on breeding, pregnant and lactating queens. Frequency Of ApplicCltion When used monthly, FRONTLINE TOP SPOT FOR CATS completely controls flea, tick and chewing lice infestations. Research demonstrates that FRONTLINE kills adult fleas for up to six weeks. FRONTLINE kills ticks for at least one month. A once monthly application is recommended where tick control is needed. Although FRONTLINE can control fleas for up to six weeks, if there is a high risk of reinfestation or if the pet has fleas which may cause flea allergy dermatitis, a once monthly application may be needed. With a monthly application, FRONTLINE TOP SPOT FOR CATS kills mosquitoes within 24 hours for up to 14 days and within 48 hours for up to 28 days. FRONTLINE remains effective even after bathing, water immersion, or exposure to sunlight. Avoid contact with treated area until dry. Do not reapply FRONTLINE for 30 days. Merial limited 3239 Satellite Blvd. Duluth, GA 30096-4640, USA MADE IN FRANCE ®FRONTLINE and TOP SPOT are registered trademarks of Merial. ©2009 Merial. All rights reserved.

EPA Reg. No. 65331-2 EPA Est. 65331-FR-2

(EPA Est. 65331-DEU-l) (EPA Est. 65331-GA-l)

(EPA Est. 74528-CHE-l)

Please call our experts at 1-800-660-1842 if you ha.e any questions or comments about flea, tick, lice and rT'OSQJltooortrolor FRONllJNETOP SPOT.

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"Flea, Tick, Chewing, Mosquito Protection:

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CATS compliance card x3 - Back

Remove the adhesive backing and attach to your refrigerator door.

Fleas, Ticks, Chewing Lice and Mosquitoes can be a year-round problem! ',;:~~~~f:~:6ttEJ~~;·' Spring Prevention

Reas and ticks start to breed more quickly as spring progresses.

Winter Prevention

The risk is still there. W"rth the cold weather, lIeas

can breed in your warm home.

Summer Prevention .. 1Ieatment

The period of highest risk. Summer temperatures and humidity

can quickly lead to huge infestations.

Autumn Prevention - Treatment

, , ;, ,nsiiVCiiom'f(jj.;use ii' " Th~ :cai~~d~r;~ti~~e'~ :~n·... . ,,' t~e fr~~t~o~:thj5'c:ord wi,n-::.- .

. . 'help you' rerf.1e~~,r ,to' apJply,:: ,FRONTUNE',;; , ''', . '; I' ~::Wrjt~{the·date. of;y~ur, ~.: ::'pet's. firs!- t~~~.t~'e~(in' the' box'shown.< ;t" .'. • " .'

2 .. After ~gyoUr poi, peel' , of1': the, sticker' corresponding' •

·to the current· month; ', .. 3 ::.~ Ploce:'the'~~m:ajnii,g . 'stj~kers' on~y~yr colend~r.:' 05,0 ~eniinder'to:apply .- .. FRONTLlNE~ monthly;or' os-needed.' . . .

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Prevems reinfestation from newly emerged adult lleas and all stages of brown dog ticks, American dog ticks, lone star

ticks, and deer ticks (which may carry Lyme disease).

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Remoye the adhesive backing and attach to your refrigerator door.

Fleas, Ticks, Chewing Lice and Mosquitoes can be 0 year.round problem!

Spring Pre'fention

Fleas and ticks statt to breed more quickly as spring progresses.

Summer Preyention .. Treatment

The period 01 highest risk. Summer temperatures and humidity

can quickly lead to huge infestations. --

Winter Autumn Preyention Prevention .. Treatment

i_Ii', ',·the'f..oiw"Uhi'ciird:Will ':",' '~~~t~~~r;t~l~~pp!y" ,~l.·;."Writ~;the 'dat~ of:your pet's,firsn~atrnerit'in th'e" .. box;shown.!· '," ., '". 2'· Aite,:treOimg)'llUr pOi,peeI off. the':~ticke.r. c~lTesponding to":the current;month} ' ..

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Preyents reinfestation from newly emerged adult lIeas and all stages 01 brown dog ticks, American dog ticks, lone star

ticks, and deer ticks (which may carry Lyme disease).

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FRONTLINE" Top Spot®

lor cats

FOR CATS & KITTENS 8 weeks or older. Convenient spot treatment for fast-acting, long-lasting control of fleas, ticks, chewing lice and mosquitoes.

ACTIVE INGREDIENT fipronil . . . . . . . . . . . . . . . . . . . . . . . . . .. 9.7% INERT INGREDIENTS ............... 90.3% TOTAL . . . . . . . . . . . . . . . . . . . . . . . .. 100.0%

KEEP OUT OF REACH OF CHILDREN CAUTION FRONTLlNE~ provides convenient and effective flea, tick, chewing lice and mosquito control for cats and kittens. • Fast-acting and long-lasting • Prevents reinfestation • Convenient to use • Kills newly emerged adult fleas before they lay eggs • Controls fleas which may cause flea allergy dermatitis • Kills all stages of brown dog ticks, American dog ticks, lone

star ticks, and deer ticks (which may carry Lyme disease) • Kills mosquitoes • Rapidly eliminates infestations with chewing lice • Can also be used on breeding, pregnant and lactating

queens • Waterproof

FRONTLINE" contains the active ingredient fipronil that effectively targets fleas, ticks, chewing lice and mosquitoes. Fipronil collects in the oils of the skin and hair follicles, and continues to be released from hair follicles onto the skin and coat, resulting in long-lasting activity.

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 PET, READ ENTIRE LABELAND DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. USE ON CATS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. To kill fleas, all stages of brown dog ticks, American dog ticks, lone star ticks, and deer ticks (which may carry Lyme disease), chewing lice and mosquitoes, apply to cats and kittens (8 weeks or older) as follows: Remove applicator from child-resistant package. Hold applicator upright and snap applicator tip away from face and body. Place applicator tip through animal's hair to the skin level between the shoulder blades. Squeeze applicator, applying entire contents in a single spot to the animal's skin. Avoid superficial application to the animal's hair. Only one applicator per treatment is needed. FRONTLINE TOP SPOT FOR CATS can also be used for the

09/1412009 TR 09/22/2009 TR

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('BACK

treatment and control of mosquitoes, and flea, tick and chewing lice infestations on breeding, pregnant and lactating queens.

FREQUENCY OF APPLICATION When used monthly, FRONTLINE'" TOP SPOT FOR CATS completely controls flea, tick and chewing lice infestations. Research demonstrates that FRONTLINE'" kills adult fleas for up to six weeks. FRONTLINE" kills ticks for at least one month. A once monthly application is recommended where tick control is needed. Although FRONTLlNE'~ can control fleas for up to six weeks, if there is a high risk of reinfestation or if the pet has fleas which may couse flea allergy dermatitis, a once monthly application may be needed. With a monthly application, FRONTLINE'" TOP SPOT FOR CATS kills mosquitoes within 24 hours for up to 14 days and within 48 hours for up to 28 days. FRONTLINE» remains effective even after bathing, water immersion, or exposure to sunlight. Avoid contact with treated area until dry. Do not reapply FRONTLlNE~ for 30 days.

STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage and disposal. STORAGE. Store unused product in original container only, out of reach of children and animals. PESTICIDE DISPOSAL. If partly filled: Call your local solid waste agency or 1-800-CLEANUP for disposal instructions. Never place unused product down any indoor . or outdoor drain. NOnn2l-iI\O\;)I1. C()(\\O'M' ~({q., II

CONTAINER DISPOSAL. If empty:" Do not reuse Athis container. Place in trash or offer for recycling if available.

FIRST AID Have the product container or label with you when calling a poison control center or doctor or going for treatment. IF SWALLOWED: Call a poison control center or 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. IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. Call a poison control center or doctor for treatment advice. IF ON SKIN: Wash with plenty of soap and water. Get medical attention if irritation persists.

PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling. HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on kittens under 8 weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product. Pets may experience some temporary irritation at the site of product application. If signs persist, or became more severe within 0 few days of application, consult a veterinarian immediately. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, debilitated or aged animals. Call 1-800-660-1842 for 24-hour assistance.

PHYSICAL OR CHEMICAL HAZARDS FLAMMABLE: Keep away from heat and open flame.

WARRANTY Seller makes no warranty, expressed or implied, cO~lcernirtg the use of this product other than indicated on t€€ IOB~I~ Buyer assumes all risk of use and handling of this material when such use and handling are contrary to label in!tr38iM's" EPA Reg. No. 65331-2 (, CeQ

Merial Limited ~ <> c ~ c ;':' 0

3239 Satellite Blvd. 0 "000

Duluth, GA 30096-4640, USA c 0 ~ t· (j ~ ~ ®FRONTLINE and TOP SPOT are (. 0 L~;: _ registered trademarks of Merial. (, t, _

©2004 Merial. All rights reserved. t L' ,.' L (. u

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TO REMOVE APPLICATOR: Lift and remove the plastic tab

to expose foil backing; then peel away the foil. Or use scissors to open.

Cat 0.017 fl oz Lot #

TO REMOVE APPLICATOR: Lift and remave the plastic tab

to expose foil backing; then peel away the foil. Or use scissors to open.

Cat 0.017 fl OZ

Lot #

Top Spot"

~ ~ TO REMOVE APPLICATOR:

Lift and remove the plastic tab to expose foil backing; then peel away the fail. Or use scissors to open.

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