us epa, pesticide product label, frontline top …...2012/04/24  · in direct response to merial...

11
10 ^ , ^ ^ UNITED STATES [ENVIRONMENTAL PROTECTION AGENCY ^^ T " WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION April 24, 2012 Ms. Kciren C. Cunningham, DVM, DABVP Head, Regulatory Affairs North America Merial Limited 3239 Satellite Boulevard, Building 500 Duluth, GA 30096-4640 Subject: Amended Master Labeling; Removal of 2-Year Time-Limited Registration Restriction FRONTLINE® Top Spot® For Cat;, EPA Reg. No. 65331-2 Your Submission Dated April 13, 2012 Dear Ms. Cunningham: The labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, is acceptable. In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events; for its FRONTLINE® products (EPA Reg. Nos. 65331-2, 65331-3, 65331-4, and 65331-5), the following changes are being made to the terms and conditicns of the subject product registration as a result of EPA's recent review (copy enclosed) of this submission: 1. The 2-year time-limited registration restriction has been removed from the subject product registration. 2. Merial's reporting of enhanced incident da:a is now only required on an annual basis, rather than on a quarterly basis because 7 years of enhanced incident data reporting have been provided and these data did not demonstrate a concern. Please note that this product is still subject to all other previously required conditions of registration, including the spot-on mitigation. A copy of your label stamped "Accepted" is enclosed for your records along with a hard copy of the HED review completed for the subject product. If you have any questions about this label review, please contact Mr. Carmen J. Rodia, Jr. at (703) 306-0327 or via e-mail at Rod/[email protected]. Sincerely Yours, Richard 1 Gebken Product Manager (10) Insecticide Branch Registration Division (7504P) Enclosures: Label stamped "Accepted" HED Memo: "Fipronil Spot-On Products: Conditional Registration and Enhanced Reporting, "dated February 27, 2012 065331-OC002 D463901

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Page 1: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

10 ̂ ,

^ ^ UNITED STATES [ENVIRONMENTAL PROTECTION AGENCY^^ T" WASHINGTON, D.C. 20460-0001

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

April 24, 2012

Ms. Kciren C. Cunningham, DVM, DABVPHead, Regulatory Affairs North AmericaMerial Limited3239 Satellite Boulevard, Building 500Duluth, GA 30096-4640

Subject: Amended Master Labeling; Removal of 2-Year Time-Limited Registration RestrictionFRONTLINE® Top Spot® For Cat;, EPA Reg. No. 65331-2Your Submission Dated April 13, 2012

Dear Ms. Cunningham:

The labeling referred to above, submitted in connection with registration under the Federal Insecticide,Fungicide and Rodenticide Act (FIFRA), as amended, is acceptable.

In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverseevents; for its FRONTLINE® products (EPA Reg. Nos. 65331-2, 65331-3, 65331-4, and 65331-5), the followingchanges are being made to the terms and conditicns of the subject product registration as a result of EPA's recentreview (copy enclosed) of this submission:

1. The 2-year time-limited registration restriction has been removed from the subject product registration.2. Merial's reporting of enhanced incident da:a is now only required on an annual basis, rather than on a

quarterly basis because 7 years of enhanced incident data reporting have been provided and these datadid not demonstrate a concern.

Please note that this product is still subject to all other previously required conditions of registration,including the spot-on mitigation. A copy of your label stamped "Accepted" is enclosed for your records along with ahard copy of the HED review completed for the subject product. If you have any questions about this labelreview, please contact Mr. Carmen J. Rodia, Jr. at (703) 306-0327 or via e-mail at Rod/[email protected].

Sincerely Yours,

Richard 1 GebkenProduct Manager (10)Insecticide BranchRegistration Division (7504P)

Enclosures: Label stamped "Accepted"HED Memo: "Fipronil Spot-On Products: Conditional Registration and Enhanced Reporting, "dated February 27, 2012

065331-OC002 D463901

Page 2: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

'.v to Apply

FRON71/NTapSpo,

-tepl.Applicator

Hold upright with (oil side toward youand snap applicator tip.

Step 2.APPLY FRONTLINE TOP SPOTPart the cat's haii above the shoulderblades, at the base of the neck. Placethe applicator tip just above the skinand squeeze. Apply entire contents ofthe applicator in a single spot directlyonto the cat's skin. Do not apply on tcpof the hair coat. Avoid contact withtreated area until dry.

Questions or Comments?Call: 1-800-660-1842,Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

>Tech-icolarea:No p nt except prod, barcode * 3 0 0 0 0 0 0 * BACK

FRONTLINETop SpaT SS.

For us<! ONLY on CATS & KITTENS 8 weeks orolder:Fast-acting, long-lasting, waterproof treatmentand ci itrol of fleas, ticks, chewing lice andmosquitoes.ACTIVKINGREDIENTfipronl 1 . 9.7%INERT \HGKIDIENTS 90.3%TOTAL 100%KEEf OUT OF REACH OF CHILDREN

CAUTIONFRON"UNE«TOP SPOT for Cats:Fleas• Kills leas• Kills newly emerged adult fleas before they lay

eggs• Stop; existing infestations and prevents

estati ishment of new infestations• Kills I eos which may cause flea allergy

derrr ititisTicks• Kills nil life stages of ticks (larva, nymph and

adui;, including brown dog ticks(Rhip:cephalus sanguineus). American dogticks' Dermocentor vafiabilis), lone star ticks(Amniyommo omericanurri) and deer ticks(Ixoi'ds scapularis)

• Kills licks that may transmit Lyme disease,hoer obartonellosis, ehrlichiosis,babe liosis. anaplasmosis and othertick-torne diseases

Lice• Rapidly eliminates chewing lice infestationsMosquitoes• Kills mosquitoesFRONTLINE TOP SPOT is approved foruse on all oats, including:• Breeding, pregnant, and lodoting queens• Kittens as young as 8 weeks

One spot application is all thats needed:FRONTLINE TOP SPOT spreads from the singlepoint of application, rapidly covering the entire catand localizing in the hair, on the surface of the skinand in the sebaceous glands.These g onds act asa reservoir, continuously replenishing FRONTLINETOP SPOT onto the skin and hair coa:, so it keepsworking even if the cat gets wet.Fleas, ticks and chewing lice are killed quickly aftercoming into contact with a treated cct. Fleas andticks do not need to bite the cat in ord* to die.DIRECTIONS FOR USEIt is a violation of Federal Law to use ttvs product ina manner inconsistent with its lobe ing. Do notallow children to apply product. TC PREVENTHARM TO YOU AND YOUR PET. RE AD ENTIRELABEL AND DIRECTIONS BEFORE EACHUSE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON CATS ONLY. DO NO' USE ONRABBITS. DO NOT USE ON OTHEP ANIMALS.To kill fleas, ticks, chewing lice and mosquitoesapply FRONTLINE TOP SPOT fcr Cats asfollows:• OPEN ApplicatorHold upright with foil side toward ycu and snapapplicator t p.• APPLY FRONTLINE TOP SPOTPart the cat's hair above the shoulder t lodes, at thebase of the neck. Place the opplic itor tip justabove the skin and squeeze. Apply en ire contentsof the applicator in a single spot direotly onto thecat's skin. Do not apply on top of the hair coot.Avoid contact with treated area until Ay.FRONTLINE TOP SPOT for Cats is approvedfor use on all cats, including breeding, pregnant.and lactating queens and kittens as young as 8weeks.FRONTLINE TOP SPOT remains effective evenafter bathing, water immersion, or jxposure tosunlight.FREQUENCY OF APPLICATIONWhen used monthly. FRONTLINE TOP SPOTcompletely controls flea, tick and ciewing liceinfestations. Do not reopply FRONTLINE TOPSPOT for 30 days.

ACCEPTED

FRONTLINEKills fleas, ticks,chewing lice& mosquitoes• Fast-acting• Long-lasting• Waterproot

1 monthly doseKills ticks, including those thatmay transmit Lyme disease

Top SpottfiffeniPHK- " "

FORCATS

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

MADE IN FRANCE

I

3 IIII00000II00000I

For use ONLY onCATS & KITTENS

8 weeksand Older

CAUTION

FRONTLINE TOP SPOT kills adult fleas for up tosix weeks, however, if there is a high risk ofreinfestation or if the cat has fleas which maycause flea allergy dermatitis, a once monthlyapplication may be needed.FRONTLINE TOP SPOT kills licks for at least onemonth. A once monthly application isrecommended where tick control is needed.FRONTLINE TOP SPOT kills oil life stages ofticks (larva, nymph and adult). FRONTLINE TOPSPOT kills ticks that may transmit Lyme disease.hoemobartonellosis. ehrlichiosis. babesiosis.anaplasmosis and other tick-borne diseases.FRONTLINE TOP SPOT kills chewing lice for atleast one month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE TOP SPOT kills mosquitoes within24 hours for up to 14 days, and within 48 hours forup to 28 days with a monthly application.STORAGE AND DISPOSALDo not contaminate water, food, or feed by storageand disposal.STORAGE. Store unused product in originalcontainer only, out of reach of children andanimals.PESTICIDE DISPOSAL If portly filled: Callyour local solid waste ogency or 1-800-CLEANUPfor disposal instructions. Never place unusedproduct down any indoor or outdoor drain.CONTAINER DISPOSAL. If empty:Nonrefillable container. Do not reuse or refill thiscontainer. Place in trash or offer for recycling ifavailable.FIRSTAIDHave the product container or label with you whencalling a poison control center or doctor or goingfor treatment.IF SWALLOWED: Coll a poison control center ordoctor immediately for treatment advice. Hoveperson sip a glass of water if able to swallow. Donot induce vomiting unless told to do so by apoison control center or doctor. Do not giveanything by mouth to on unconscious person.IF IN EYES: Hold eye open and rinse slowly andgently with water for 15-20 minutes. Remove

FRONT

contact lenses, if present, after the first 5 minutes,then continue rinsing eye. Call a poison controlcenter or doctor for treatment advice.IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for 15-20 minutes. Call a poisoncontrol center or doctor for treatment advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS. CAUTION.Harmful if swallowed. Causes eye irritation. Avoidcontact with skin, eyes or clothing. Wash handsthoroughly with soop and water after handling andbefore eating, drinking, chewing gum. or usingtobacco.HAZARDS TO DOMESTIC ANIMALS.For external use only. Do not use an kittens under 8weeks of age. Individual sensitivities, while rare,may occur after using any pesticide product. Petsmay experience some temporary irritation at thesite of product application. If signs persist, orbecome more severe within a few days ofapplication, consult a veterinarian immediately.Certain medications con interact with pesticides.Consult a veterinarian before using on medicated,debilitated or aged animals. Call 1-800-660-1842.Monday-Friday, 8om-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat oropen flame.WARRANTYTo the extent consistent with applicable law, sellermakes no warranty, expressed or implied,concerning the use of this product other thanindicated on the label. Buyer assumes all risk ofuse and handling of this material when such useand handling ore contrary to label instructions.

Merial Limited3239 Satellite Blvd.Duluth.SA 30096-4640. USA©FRONTLINE and TOP SPOTare registered trademarks of Merial.©2011 Merial Limited, Duluth.GA.All rights reserved.

f.<f, INSIDE PANELS

and Rodenticide Act, as amended, fertilepesticide registered under

\. Reg. No:.

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C

ft•H

0

Page 4: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

H<*1\

FRONTLINE '\3»Top Spot

Kills fleas, ticks,chewing lice & mosquitoes »

• Fast-acting• Long-lasting• Waterproof

Kills ticks, including those thatmay transmit Lyme disease

For use ONLY onCATS & KITTENS

8 Weeksand Older

ACTIVE INGREDIENT:Fipranil: 9.7%INERT INGREDIENTS: ...90.3%TOTAL: 100%Contains 3 -0.017floz(0.50mL)opplicatms

SEE INSERT FOR FIRST AID AND PRECAUTIONARY STATEMENTS.

KEEP OUT OF REACH OF CHILDRENCAUTION

PROTOTYPE GRAPHICS

Page 5: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

FRONTUNFTopSpofS&

FRONTLINE® TOP SPOT* for Cats is:• Fast-acting• Long-lasting• Waterproof

One spot application is all that's needed:FRONTLINE TOP SPOT spreads from the single point of application, rapidly coveringthe entire cat and localizing in thi> hair, on the surface of the skin and in the sebaceousglands. These glands act as a reservoir, continuously replenishing FRONTLINE TOPSPOT onto the skin and hair coa, so it keeps working even if the cat gets wet.Fleas, ticks and chewing lice ore cilled quickly after coming into contact with a treatedcat. Fleas and ticks do not need (3 bite the cat in order to die.

FRONTLINE TOP SPOT for Cats:

Fleas• Kills fleas• Kills newiy emerged adult fleas oefore they lay eggs• Stops existing infestations and prevents establishment of new infestations• Kills fleas which may cause flea allergy dermatitisTicks• Kills all life stages of ticks (lorva nymph and adult), including deer ticks (Ixodes

scapularis), brown dog ticks (KnipicepMus sanguineus). American dog ticks(Dermacentor voriabilis) and lo ie star ticks (Amblyomma americanum)

• Kills ticks that may transmit Lynie disease. Rocky Mountain spotted fever, ehrlichiosis,babesiosis, anaplasmosis, haemobartonellosis and other tick-borne diseases

Lice Mosquitoes• Rapidly eliminates chewing lice infestations • Kills mosquitoes

FRONTLINE TOP SPOT is apf roved for use on all cats, including:Breeding, pregnant, and lactating queensKittens as young as 8 weeks

Adult Fleas

Ticks

Chewing Lice

Mosquitoes

Page 6: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

Hovs to Apply

FRONTLINE

Step .J

Step I. To REMOVE Applicator:Lift and remove the plastic tab to exposefoil backing; then peel away the foil.Or use scissors to open.

Step:!. ApplicatorHold upright with foil side toward youand snap applicator tip.

APPl Y FRONTLINE TOP SPOTPart the cat's hair above the shoulderblades, at the base of the neck. Placethe applicator tip just above the skinand squeeze. Apply entire contents ofthe applicator in a single spot directlyonto the cat's skin. Do not apply on topof the hair coat. Avoid contact withtreated area until dry.

Questions or Comments?Call: 1-800-660-1842.Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

f?oCoa>

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( - f t f l l

(1)a:

jap/0 PUP8

FRONTLINEFRONTLINE TOP SPOT for Cots provides fast-acting, long-lasting, waterproof treatment and controlof fleas, ticks, chewing lice and mosquitoes for use ONLY on cats and kittens 8 weeks or older.

Directions far UseIt is a violation of Federal Law to use this product in a manner inconsistent with its labeling. Donot allow children to apply product. TO PREVENT HARM \'0 YOU AND YOUR PIT. READ ENTIRE LABEL ANDENCLOSED DIRECTIONS BEFORE EACH USE. FOLLOW AL. DIRECTIONS AND PRECAUTIONARY STATEMENTSCAREFULLY. USE ON CATS ONLY. DO NOT USE ON RABB, TS. DO NOT USE ON OTHER ANIMALS.

To kill fleas, ticks, chewing lice and mosquitoes apply FRONTLINE TOP SPOT for Cats as follows:• To REMOVE Applicator: Lift and remove the plastic fab o expose foil backing; then peel away the foil. Or use

scissors to open.• OPEN Applicator. Hold upright with foil side toward you and snap applicator tip.• /m/FRONTLINE TOP SPOT. Part the cat's hair abwe the shoulder blades, at the base of the neck. Place

the applicator tip just above the skin and squeeze. Apply entire contents of the applicator in a single spotdirectly onto the cat's skin. Do not apply on top of the lair coat. Avoid contact with treated area until dry.

FRONTLINE TOP SPOT for Cats is approved for use jn all cats, including breeding, pregnant, and lactatingqueens and kittens as young as $ weeks.FRONTLINE TOP SPOT remains effective even after be thing, water immersion, or exposure to sunlight.

Frequency of ApplicationWhen used monthly. FRONTLINE TOP SPOT completely controls flea, tick and chewing lice infestations.Do not reapply FRONTLINE TOP SPOT for 30 days.FRONTLINE TOP SPOT kills odult fleas for up to six weeks, however, if there is a high risk ofreinfestation or if the cat has fletis which may cause flea allergy dermatitis, a once monthly application maybe needed.FRONTLINE TOP SPOT kills licks for at least one month. A once monthly application is recommendedwhere tick control is needed. FRONTLINE TOP SPOT ti l ls all life stages of licks (larva, nymph and adult).FRONTLINE TOP SPOT kills ticks that may transmit Lyme disease. Rocky Mountain spotted fever, ehrlichiosis.babesiosis, onaplasmosis, haemobartonellosis and other tick-borne diseases.FRONTLINE TOP SPOT kills crewing lice for at least one month.A once monthly application is recommended where chewing lice control is needed.FRONTLINE TOP SPOT kills mosquitoes within 24 hours for up to 14 days, and within 48 hours for up to28 days, with a monthly application.

NUNOUJ

* FPAEs- 65331 -FR-2

: i EPA Es' . 74528-CHE-1

Page 8: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

FRONTLINE*top Spot*

TO REMOVE APPLICATOR:• Lift ond remove the plastic tab

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

0.017 flozLot*

CAT

FRONJUNE'rap Spot"

TO REMOVE APPLICATOR:Lift c nd remove the plastic tab

to expose foil backing; then peelaway tho foil. Or use scissors to open.

0.017 flozLot*

CAT

FR

TO REMOVE APPLICATOR: 'Lift and remove the plastic tab *

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

0.017 flozLot#

CAT

Page 9: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

I

ONLYFORCATSAND

.KITTENS

§10.017 fi oz

FRONTUNt®Top Spot'-"

Keep out of teach of childrenSee full label for

additional directionsCAUTION

EPA Reg. No. 65331-2

Page 10: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

FRONTLINETop

For use ONLY on CATS & KITTENS 8 weeks or older:Fust-acting, long-lasting, waterproof treatment and control offl ; as, ticks, chewing lice and mosquitoes.ACTIVE INGREDIENTfipronil ........................................................................ 9.7%lliERT INGREDIENTS ................................................... 90.3%7i:>Ml ......................................................................... 100%

KEEP OUT OF REACH OF CHILDRENCAUTION

FRONTLINE® TOP SPOT® for Cats:FI30S

• (ills fleas• (ills newly emerged adult fleas before they lay eggs• Stops existing infestations and prevents establishment of new

infestations• (ills fleas which may cause flea allergy dermatitisTi=ks• (ills all life stages of ticks (larva, nymph and adult), including

brown dog ticks (Rhipicephalus sanguineus), American dog ticks( Dermacentor variabilis), lone star ticks (Amblyommaamericanum) and deer ticks (Ixodes scapuloris)

• (ills ticks that may transmit Lyme disease,haemobortonellosis, ehrlichiosis, babesiosis, anaplasmosisiind other tick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsMosquitoes• (ills mosquitoesFRONTLINE TOP SPOT is approved for use on all cats,including:• breeding, pregnant, and lactating queens• (ittens as young as 8 weeksCine spot application is all that's needed:FRONTLINE TOP SPOT spreads from the single point ofaf plication, rapidly covering the entire cat and localizing in the hair.o-i the surface of the skin and in the sebaceous glands. Thesegonds act as a reservoir, continuously replenishing FRONTLINETOP SPOT onto the skin and hair coat, so it keeps working even iftr ; cat gets wet.Floes, ticks and chewing lice are killed quickly after coming intoa ntact with a treated cat. Fleas and ticks do net need to bite the catir order to die.DIRECTIONS FOR USEIt is a violation of Federal Law to use this product in a mannerir consistent with its labeling. Do not allow chilcren to apply product.TO PREVENT HARM TO YOU AND YOUR PET, READ ENTIRELABEL AND DIRECTIONS BEFORE EACH USE. FOLLOWALL DIRECTIONS AND PRECAUTIONARY STATEMENTSCAREFULLY. USE ON CATS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHER ANIMALS.To kill fleas, ticks, chewing lice and mosquitoes apply FRONTLINETOP SPOT for Cats as follows:• To REMOVE Applicator: Lift and remove the plastic tab to exposefc I backing; then peel away the foil. Or use scissors to open.• OPEN ApplicatorHold upright with foil side toward you and snap applicator tip.• APPLY FRONTLINE TOP SPOTPvrt the cat's hair above the shoulder blades, at the base of then-!Ck. Place the applicator tip just above the skin and squeeze. Applyentire contents of the applicator in a single spot directly onto thec<:t's skin. Do not apply on top of the hair coct. Avoid contact withtreated area until dry.

* 7 0 0 0 0 0 0 *

FRONTLINE TOP SPOT for Cats is approved for use on all cats,including breeding, pregnant, and lactating queens and kittens asyoung as 8 weeks.FRONTLINE TOP SPOT remains effective even after bathing,water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINE TOP SPOT completely controlsflea, tick and chewing lice infestations. Do not reapply FRONTLINETOP SPOT for 30 days.FRONTLINE TOP SPOT kills adult fleas for up to six weeks,however, if there is a high risk of reinfestation or if the cat has fleaswhich may cause flea allergy dermatitis, a once monthlyapplication may be needed.FRONTLINE TOP SPOT kills ticks for at least one month. A oncemonthly application is recommended where tick control is needed.FRONTLINE TOP SPOT kills all life stages of ticks (larva, nymphand adult). FRONTLINE TOP SPOT kills ticks that may transmitLyme disease, haemobartonellosis, ehrlichiosis, babesiosis,anaplasmosis and other tick-borne diseases.FRONTLINE TOP SPOT kills chewing lice for at least one month.A once monthly application is recommended where chewing licecontrol is needed.FRONTLINE TOP SPOT kills mosquitoes within 24 hours for up to14 days, and within 48 hours for up to 28 days with a monthlyapplication.STORAGE AND DISPOSALDo not contaminate water,food, or feed by storage and disposal.STORAGE. Store unused product in original container only, out ofreach of children and animals.PESTICIDE DISPOSAL. If partly filled: Call your local solidwaste agency or 1-800-CLEANUP for disposal instructions. Neverplace unused product down any indoor or outdoor drain.CONTAINER DISPOSAL. If empty: Nonrefillable container.Do not reuse or refill this container. Place in trash or offer forrecycling if available.FIRST AIDHave the product container or label with you when calling a poisoncontrol center or doctor or going for treatment.IF SWALLOWED: Call a poison control center or doctorimmediately for treatment advice. Have person sip a glass of waterif able to swallow. Do not induce vomiting unless told to do so by apoison control center or doctor. Do not give anything by mouth to anunconscious person.IF IN EYES: Hold eye open and rinse slowly and gently with waterfor 15-20 minutes. Remove contact lenses, if present, after the first5 minutes, then continue rinsing eye. Call a poison control center ordoctor for treatment advice.IF ON SKIN OR CLOTHING: Take off contaminated clothing.Rinse skin immediately with plenty of water for 15-20 minutes. Calla poison control center or doctor for treatment or advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS. CAUTION.Harmful if swallowed. Causes eye irritation. Avoid contact with skin,eyes or clothing. Wash hands thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, or using tobacco.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 anypesticide product. Pets may experience some temporary irritation atthe site of product application. If signs persist, or become moresevere within a few days of application, consult a veterinarianimmediately. Certain medications can interact with pesticides.Consult a veterinarian before using on medicated, debilitated oraged animals. Call 1 -800-660-1842, Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat or open flame.WARRANTYTo the extent consistent with applicable law, seller makes nowarranty, expressed or implied, concerning the use of this productother than indicated on the label. Buyer assumes all risk of use andhandling of this material when such use and handling are contraryto label instructions.EPA Reg. No. 65331-2Merial Limited3239 Satellite Blvd.Dululh.GA 30096-4640. USA©FRONTLINE and TOP SPOT are registered trademarks of Merial.©2011 Meriol limited. Duluth. GA.All rights reserved.

FRONT BACK

Page 11: US EPA, Pesticide Product Label, FRONTLINE TOP …...2012/04/24  · In direct response to Merial Limited's subnission (September 9, 2011) of enhanced reporting of adverse events;

RONTLINE

To successfully control fleas and ticls, alldogs and cats must be treated with theii owndose of FRONTLINE'.

v Apply according to label instruction::,ensuring the product is applied to the s (in,not on top of the fur and not near the cellar.It may be helpful to remove the collar beforeapplication, so It doesn't absorb the product.

v Remember, your pet needs to be dry at thetime FRONTLINE is applied and remain dry24 hours after application.

•"' Verify pipette is empty after application(multiple squeezes may be necessary tcapply the entire dose).

- Even Indoor pets need flea and tick controlbecause you or other pets in the housed Didmay bring fleas into the home. These fleascan lead to a flea Infestation.

O OTick-. Chewing

- -A V* V*w It can take up to3 months to get rid of

_ a serious flea infestationause of all of the flea life stages that

existed BEFORE you started using FRONTLINE.

The adult fleas on your pet may justbe the tip of the infestation iceberg.

S% Aatill Fieas A Mui: fitt-i tin if K- 120 tfcrs I

The average flea lite cycle in thehome is about 27 days long.

6 Monthsuse all 6 stickers

3 Months

To ensure continued protection of yourpets, use these stickers as a reminderto apply cind re-purchase FRONTLINE.

After treating your pet for the first time,peel off the sticker and place on yourcalendar 1tiat day.

Place the 'emaining stickers on yourcalendar as a reminder to applyFRONTLINE monthly.

autsnoiKJContact your veterinorionor coll our tectinicolexperts ot1-800-460-1842,MondofFriday, 8am-8pm.For more information, visitwww.FliONTUNE.com

®FRONTUNEiso

of Me*!.©201 IMeriol limited,Dubth,GA.All rights reserved.