U.S. EPA, Pesticide Product Label, FRONTLINE PLUS FOR CATS ...

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Zareen Ahmed, Ph.D. Merial 3239 Satellite Blvd. Duluth, GA 30096-4640

Dear Dr. Ahmed:

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Subject:

Frontline Plus for Cats

EPA Reg. No. 65331-4

Letter dated 5/24/01

The labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is acceptable subject to the comments listed below. One copy of the finished labeling must be submitted prior to releasing the product for shipment.

In accordance with PR Notice 2001-1, you are strongly urged to change the skin and eye First

Aid Statements to read as follows:

If on skin or clothing:

-Take off contaminated clothing.

-Rinse skin immediately with plenty of water for 15-20 minutes.

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

Alternately, you may delete the skin and eye first aid statements.

If you have questions, please call Ann Sibold at 703 305-6502.

Sincerely,

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t . ~ Marion 1. Johnson, Jr. Product Manager 3 Insecticide Branch Registration Division (7505C)

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Master Label Carton

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Kills fleas, flea eggs & ticks

? Fost-acting

? Kills ticks including those that may transmit Lyme disease

? Waterproof

For Cats &Kittens

8 weeks or older

A~ 'JE IN''::~ED1Ef\,-~

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fipr~~01 (S)-~oprene

9.8% 11.8%

INERi ING'EDIEN~ 78.4%

TOTAL

100.0%

KEEP OUT OF REACH OF CHILDREN

CAUTION

COr:"oins:3 :')-0.017 -i oz (05: mil '::>;.:>Iicotori

(PROTOTYPE GRAPHICS)

Printed at 110% Actual Size

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How to Apply

1. Rem-~ve Applicator from Child~Resistant Package

Use scissors. Or lift and remove plastic tab to expose

foil, then peel down.

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2. Open Applicator

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Hold upright and snap applicator tip away from face ~ I

and bady_

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3. Apply FRONTLINE PLUS FOR CATS 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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Adult Flea

FRONTLINE PLUS FOR CATS.~roYides fast, effective and convenient treatment and cONrol of fleas ':ind ticks for cats and kittens 8 weeks

or older.

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Flea Egg~

Stops and prevents infestations Kills adult Reas, Rea eggs & Ilea larvae Prevents all Rea stages (eggs, larvae, pupae) from developing Kills fleas which may cause Rea allergy dermatitis Kills all stages 01 deer ticks (which may carry Lyme disease), brown dog ticks, American dog ticks & lone star ticks Prevents and controls reinfestations Fast..acting Long-lasting

Waterproof

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Flea larvae

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Flea Pupae

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Brown Dog Tick

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Convenient to use

FRONTLINE PLUS FOR CATS contains fipronil and the insect growth regulotor (IGR) (S)-methoprene. FRONTLINE PLUS effectively torgets

lone Star Tick

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all stages of fleas Fipronil collects in the oils of the skin and hair

Deer Tick

follicles, and continues to be released from hair follicles onto the skin and coot, resulting in long-lasting activity against fleas and ticks.

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American Dog Tick

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FRONTLINE PLUS FOR CATS provides fast, effective and convenient treatment and control of fleas and ticks for cats and kittens 8 weeks or older

Directions For Use

It is a violation of Federal low to use this product ~o manner inconsistent with its labeling. Do not 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 and all stages of brown dog ticks, American dog ticks, lone star ticks, and deer ticks (which may corry Lyme disease), 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 7~e 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

Frequency Of Application

When used monthly, FRONTLINE PLUS FOR CATS completely breaks the flea life cycle and controls &k infestations. Research demonstrates that FRONTLINE PLUS kills adult fleas, flea eggs, and flea lar.ue for up to six weeks. FRONTLINE PLUS also prevents development of all flea stages for up to six weeks. FRONTLINE PLUS kills &ks for at least one month. A once monthly application is recommended ....here tick control is needed. Atthough FRONTLINE PLUS can control fleas for up to six weeks, if there is a high risk of reinfestotion or if the pet has fleas which may couse flea allergy dermatitis, a once monthly application may be needed.

FRONTLINE PLUS remoins effective even after bathing, water imme~ion, or exposure to sunlight A\.Qid contact with treated area until dry. Do not reapply FRONTLINE PLUS for 30 days.

Meriallimited 3239 Satellite Blvd. Duluth, GA 30096-4640, USA

MADE IN FRANCE

IDFRONTLINE is a registered trademark of Merial. ?1200 I Merial. All rights reserved

EPA Reg. No. 65331-4 EPA Est. 65331-FR-2 (EPA Est. 65331-DEU?l)

~f ,.0~ :r~ not s.c-:S-'ed with FROr.--,'NE PLl:5 for any rro,.()' "'e pmcLc WIll be replo:.o-: or thE ~urchose pnce "'?"~nded If . ................
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