united states environmental protection agency …apr 24, 2012  · • his all life stages of licks...

11
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION April 24, 2012 Ms. Karen 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 Dogs, EPAReg. No. 65331-3 Your Submission Dated April 13, :>012 Dear Ms. Cunningham: The labeling referred to above, submitted n connection with registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, is acceptable. In direct response to Merial Limited's submission (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 conditions 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 data 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 subjed: to all other previously required conditions of registration, includhg 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: "Fipmnil Spot-On Products: Conditional Registration and Enhanced Reporting, "dated February 27, 2012 065331-IXX03 M63904

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Page 1: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460-0001

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

April 24, 2012

Ms. Karen 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 Dogs, EPA Reg. No. 65331-3Your Submission Dated April 13, :>012

Dear Ms. Cunningham:

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

In direct response to Merial Limited's submission (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 conditions 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 data 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 subjed: to all other previously required conditions of registration,includhg 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: "Fipmnil Spot-On Products: Conditional Registration and Enhanced Reporting, "dated February 27, 2012

065331-IXX03 M63904

Page 2: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

/

,

How to Apply

FRONTLINETop Spot

ifi

Stepl.Applicator

Hold upright with foil side toward youand snap applicator tip.

Step 2.APPLY FRONTLINE TOP SPOTPart the dog's hair between theshoulder blades. Place the applicator tipjust above the skin and squeeze. App yentire contents of the applicator in asingle spot directly onto the dog's ski i.Do not apply on top of the hair coot.Avoid contact with treated area until dry.

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

Technical areaM print except prod, barcode

FRONTLINETop Spotnncnicurc- *

Kills fleas, ticks,chewing lice& mosquitoes• Fast-acting gJJ,,. ,7%• Long-lasting «̂G™::.....:.m%• WaterprOOf [Contains 1-0.091 «02(2.6B mL; applicator 3

1 monthly dose

Kills ticks, including those thatmay transmit Lyme disease

FORDOGS

3 ••-UUUUITUUUUU"" 1r For use ONLY on DOGS

See inside panelslor FIRST AID and

KEEP OUWF REACH OF CHILDREN PRECAUTIONARY

CAUTION statements.

II

FRONT

FRONTLINE'TopSpof'&

For jse ONLY an 0065 « PUPPICS 8 weeks orold inFast-acting, long-lasting, waterproof treatmentanil control of fleas, ticks, chewing lice,sar :optic mites and mosquitoes.

hpinnil ......... _._.„„ ..... 97%/Wiff IHGKEDIfHJS ............................ 90.3%roi;u ____________________ ....................... 100.0%KfEP OUT OF REACH OF CHILDREN

CAUTIONFRONTLINE" TOP SPOT* lor Dogs:Fleas• Hills teas• >:lls newly emerged odult fleas before they lay

e:gs• :• ops existing infestations and prevents

establishment of new infestations• * Us fleas which may cause flea allergy

dermatitisTicks• His all life stages of licks (larva, nymph and

adult), including brown dog ticks(.• hipicephalus songu/neus). American dogti: ks (Dermocentof rariabi/is). lone star licks(.< mblyomma americanum") and deer ticks('.vdes scapuioris)

• ». Us ticks that may transmit Lyme disease,Rucky Mountain Spotted Fever, ehrlichiosis.biibesiosis, onaplasmosis and other tick-bornediseases

Ue*• (' ipidly eliminates chewing lice infestationsMHH• /. ds in control of sarcoptic mange infestationsMosquitoes• >! Us mosquitoesFRONTLINE TOP SPOT is approved forUS': on all dogs, including:• Si eeding, pregnant, and loctatmg bitches• F jppies as young as 8 weeks

ACCEPTED

One spot application is all that'sneeded:FRONTLINE TOP SPOT spreads fro-n the singlepoint of application, rapidly covering It e entire dogand localizing in the hair, on the surface of the skinand in the sebaceous glands.These glc nds act as areservoir, continuously replenishing FRONTLINETOP SPCT onto the skin and hair coct. so it keepsworking even if the dog gets wet.Fleas, ticks and chewing lice ore killed quickty aftercoming into contacl with a treated dcg. Fleas andticks do not need to bite the dog in offer to die.

DIRECTIONS FOR USCIt is a violation of Federal Law to use this product ina manner inconsistent with its labeling. Do notallow children to apply product. TC PREVENTHARM TO YOU AND YOUR PET. READ ENTIRELABEL AND DIRECTIONS BEFORE EACHUSE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON DOGS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHEl? ANIMALS.To kill fleas, ticks, chewing lice and mosquitoesapply FRONTLINE TOP SPOT for Dogs asfollows:• OPENApplicatorHold upright with foil side toward ycu and snapapplicator tip.• APPLY FRONTLINE TOP SPOTPort the dog's hair between the shoi Ider blades.Place the applicator tip just above he skin andsqueeze.Apply entire contents of Ihe applicator in asingle spot directly onto the animal's skin. Do notapply on lop of the hoir coat. Avoid :ontact withtreated are a until dry.FRONTLINE TOP SPOT for Dogs is approved loruse on breeding, pregnant, and Tactc ting bitchesand puppies as young as 8 weeks.FRONTLINE TOP SPOT remains elective evenafter bathing, water immersion, or jxposure tosunlight.

FREQUENCY OF APPLICATIONWhen used monthly. FRONTLINE TOP SPOTcompletely controls fleo, tick and chewing liceinfestations. Do not reapply FRONTLINE TOPSPOT for .30 days.FRONTLINE TOP SPOT kills adult fl ;os for up tothree months, however, if there is a high risk ofreinfestation or if the dog has fleas which maycause flea ollergy dermatitis, o orce monthly

application may be needed.FRONTLINE TOP SPOT kills ticks for at least onemonth. A once monthly application isrecommended where lick control is needed.FRONTLINE TOP SPOT kills oil life stages of ticks(larva, nymph and adult). FRONTLINE TOPSPOT kills ticks that may transmit Lyme disease,Rocky Mountain Spotted Fever, ehrlichiosis,babesiosis, onaplasmosis and other tick-bornediseases.FRONTLINE TOP SPOT kills chewing lice for atleast one month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE TOP SPOT aids in the control ofsorcoptic mange infestations. Multiple monthlytreatments ore recommended for the eliminationof mites.FRONTLINE TOP SPOT kills mosqurtoes within 24hours for up to 7 days, and within 48 hours for up to28 days with a monthly applicotion.

STORAGE AND DISPOSALDo not contaminate water, tood. or feed by storageand disposal.STORAGE. Store unused product in originalcontainer only, out of reach of children andanimals.PESTICIDE DISPOSAL If partly filled: Collyour local solid waste agency or 1-ODD-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: Call o poison control center ordoctor immediately for treatment advice. Haveperson sip o 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 an unconscious person.IF IN EYES: Hold eye open ond rinse slowly andgently with water for 15-20 minutes. Removecontact lenses, if present, after the first 5 minutes,then continue rinsing eye. Call a poison control

INSIDE: PANELS

center or doctor tor treatment advice.IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for 15-20 minutes. Coll o 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 usingtobocco.

HAZARDS TO DOMESTIC ANIMALS.For external use only. Do not use on puppies under8 weeks of age. Individual sensitivities, while rare,may occur after using any pesticide product. Pelsmay experience some temporary irritation at thesite of product application. If signs persist, orbecome more severe within a few days ofapplication, consult a veterinarian Immediately. Ifyour pet has an unusual reaction to the initialapplication, consult a veterinarian before repeatingtreatment. Certain medications can interact withpesticides. Consult a veterinarian before using onmedicated, debilitated or aged animals. Call1-600-660-1842. Mondoy-Fridov. BanWipm EST.

PHYSICAL OR CHEMICU HAZARDSCOMBUSTIBLE: Do not use r • r'O' r ear heat oropen flame.

HOW SUPPLIEDFor easy and convenient treatment. FRONTLINETOP SPOT for Dogs is ovoilpole in sizes for useONLY on small dogs and puppies 8 weeks or olderond up to 22 Ibs.. medium dogs 23-44 Ibs.. largedogs 45-88 Ibs.. ond extra lo-ge dogs "9-132 IBs.WARRANTYTo the extent consistent with Applicable low. sellermakes no warranty, expressed or implied,concerning the use of this PIJOJU uther thanindicated on the label. Buyer assumes a.; risk ofuse and handling of this material when such useand handling are contrary to label instructions.Meriol Limited3239 Satellite Blvd.Duluth.GA 30096-4640. USA©FRONTLINE ond TOP SPOTore registered trademarks of Meriol.©2011 Merial Limited. Duluth Grt.All rights reserved.

Under the Federal Insecticide, Fungfcido,and Rodenticide Act, as amended, fiorfte

pesticide registered under

EPA. Reg. Kb: 6* 33* "3

Contains 1-0 023II02 (I'.67 mL) applicatorContains 1-0.045 « oz f .34 mL) applicatorContains 1-0.136 « oj • .02 mL) applicator

For use ONLY onDOGS & PUPPIES8 Weeks or Olderand up to

For use ONLY on DOGS

22 Ibs23te

44,,,,For use ONLY on DOGS

89to132,bs

Page 3: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

0

c

Page 4: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

I

TopKills fleas, ticks,chewing lice & mosquitoes

• Fast-acting• Long-lasting• Waterproof

Kills ticks, including those thatmay transmit Lyme disease

2tor use PNlV'on DOG5

2344For use ONlYon DOGS

4588For use CWJ.V or POGt

ACTIVE INGRCDIEffl:Fipronil: 9.7%INERT INGREDIENTS: ... 90.3%rOHl: 100%

SEE INSERT FOR FIRST AID AND PRECAUTIONARY STATEMENTS

KEEP OUT OF REACH OF CHILDREN

• . . : .

89132PROTOTYPE GRAPlilCS

Page 5: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

*FRONTLINETop Spot'gg,

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

One spot application is all that s needed:FRONTLINE TOP SPOT spreads from the single point ot application, rapidly coveringthe entire dog and localizing in tt e 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 dog gets wet.Fleas, ticks and chewing lice are ailed quickly after coming into contact with a treateddog. Fleas and ticks do not need to bite the dog in order to die.

FRONTLINE TOP SPOT for Cogs:

Fleas• Kills fleas• Kills newly emerged adult fleas before 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 (larvii. nymph and adult), including deer ticks (Ixodes

scapularis), brown dog ticks (R.iipicephalus sanguineus). American dog ticks(Dermacentor variobilis) and loie star ticks (Amblyomma americanum)

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

Lice Mosquitoes• Rapidly eliminates chewing lice infestations • Kills mosquitoesMites• Aids in control of sarcoptic mange infestationsFRONTLINE TOP SPOT is approved for use on all dogs, including:

Breeding, pregnant, and lactating bitchesPuppies as young as 8 weeks

Adult Fleas

Ticks

Chewing Lice

Mosquitoes

PROTOTYPE GRAPHICS

Page 6: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

Step!!.

Hovf to Apply

FRONTLINE

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

ApplicatorHold upright with foil side toward youand snap applicator tip.

£?o

Stepa. APPLY FRONTLINE TOP SPOTPart the dog'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 dog'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

Page 7: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

O_,o

co XCO X

or uja. a.UJ LU

ZEI68 889*•&OC '->•'* • !•" ' -r.7 'in I NO I1"1 ">J

W^CZ 22

FRONTLINETop Spot

FRONTLINE TOP SPOT for Dogs provides fast-acting, long-lasting, waterproof treatment and controlof fleas, ticks, chewing lice, sarcoptic mites and mosquitoes for use ONLY on i^gs and puppies 8 weeks or older'.in!1 up to 22 Ibs dogs weigher. 31 ilJ bs. Mnn • ihinq 89 132 IDS.).

Directions for UseIt is a violation of Federal Law to use this product in a munner inconsistent with its labeling. Donot allow children to apply product. TO PREVENT HARM '0 YOU AND YOUR PET. READ ENTIRE LABEL ANDENCLOSED DIRECTIONS BEFORE EACH USE. FOLLOW Ai. DIRECTIONS AND PRECAUTIONARY STA TEMENTSCAREFULLY. USE ON DOGS ONLY. DO NOT USE ON RABl ITS. DO NOT USE ON OTHER ANIMALS.

To kill fleas, ticks, chewing lice and mosquitoes apply FPONTLINE TOP SPOT for Dogs as follows:• To REMOVE Applicator: Lift and remove the plastic tab 'o expose foil backing: then peel away the foil. Or usescissors to open.• OPEN Applicator. Hold upright with foil side toward you and snap applicator tip.• APPLY FRONTLINE TOP SPOT. Port the dog's hair between the shoulder blades. Place the applicator tipjust above the skin and squeeze. Apply entire contents o: the applicator in a single spot directly onto theanimal's skin. Do not apply on tcp of the hair coat. Avoic contact with treated area until dry.FRONTLINE TOP SPOT for Dogs is approved for use on breeding, pregnant, and lactating bitches andpuppies as young as 8 weeks.FRONTLINE TOP SPOT remairs 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 acult fleas for up to three -nonths. however, if there is a high risk ofreinfestation or if the dog has fleas which may cause Bed allergy dermatitis, a once monthly application maybe needed.FRONTLINE TOP SPOT kills tides for at least one month. A once monthly application is recommendedwhere tick control is needed. FRONTLINE TOP SPOT kills all life stages of ticks (larva, nymph and adult).FRONTLINE TOP SPOT kills ticks that may transmit Lyme disease. Rocky Mountain spotted fever, ehrliohiosis,babesiosis, anaplasmosis and other tick-borne diseases.FRONTLINE TOP SPOT kills chewing lice for al least oie month.A once monthly application is recommended where chewing lice control is needed.FRONTLINE TOP SPOT aids in the control of sarcoptic mange infestations. Multiple monthly treatments arerecommended for the elimination of mites.FRONTLINE TOP SPOT kills mosquitoes within 24 hours for up to 7 days, and within 48 hours for up to28 days, with a monthly application.

3 "•I00000"00000"" 1

EPA Esl. 65331-FR-2

Ivers I ee EPA Esl. 74528-CHE-1

Page 8: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)
Page 9: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

M

m2

ONLYFOR

DOGS23-44 Ibs.

fop Spof8Keep out ot reach of children

See full label foradditional directionsCAUTION

EPft Reg. No. 65331-3

ONLYFOR

DOGS45-88 Ibs.

0.091 fl 02

FRONTLINEfop Spot *

Ki";p*IIot^ir;ho1crrlf]..TlSee full label for

additional directionCAUTION

E-'A Reg. No. 65331-3

ONLYFOR

DOGS

fRONTp*"pot

CAUTION

Page 10: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

FRONTLINETop Spof™ s

For use ONLY on DOGS & PUPPIES 8 weeks or older:F:st-acting, long-lasting, waterproof treatment and control olfliias, ticks, chewing lice, sarcoptic mites and mosquitoes.ACTIVE INGREDIENTfi|ironil 9.7%IKERT INGREDIENTS 90.3%WTAL 100.0%

KEEP OUT OF REACH OF CHILDRENCAUTION

FI!ONTLINE»TOP SPOT8 for Dogs:Fleas• <ills fleas• <ills newly emerged adult fleas before they lay eggs• Stops existing infestations and prevents establishment of new

nfestations• (ills fleas which may cause flea allergy dermatitisTicks• <ills all life stages of ticks (larva, nymph and adult), including

brown dog ticks (Rhipicephalus sangu/neus),American dog ticksiDermacentor variabilis), lone star ticks (Amblyommajmer/conum) and deer ticks (Ixodes scapularis)

• <ills ticks that may transmit Lyme disease. Rocky MountainSpotted Fever, ehriichiosis, babesiosis, anaplasmosis and otherick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsfv'ites• <\ids in control of sarcoptic mange infestatioisIVosquitoes• <ills mosquitoesFRONTLINE TOP SPOT is approved for use on allcogs, including:• Breeding, pregnant, and lactating bitches• Puppies as young as 8 wee_ksCine spot application is all that's needed:FRONTLINE TOP SPOT spreads from the single point otapplication, rapidly covering the entire dog and localizing in theh:iir, on the surface of the skin and in the sebaceous glands.Thesegbnds act as a reservoir, continuously replenishing FRONTLINETOP SPOT onto the skin and hair coat, so it keeps working even itthe dog gets wet.F ;as. ticks and chewing lice are killed quickly after coming intoCMitact with a treated dog. Fleas and ticks do not need to bite thed:ig in order to die.DIRECTIONS FOR USE|t is a violation of Federal Law to use this product in a mannerinconsistent with its labeling. Do not allow children to apply productTO PREVENT HARM TO YOU AND YOUR PET, READ ENTIRELABEL AND DIRECTIONS BEFORE EACH USE. FOLLOWALL DIRECTIONS AND PRECAUTIONARY STATEMENTSCAREFULLY. USE ON DOGS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHER ANIMALS.Ti: kill fleas, ticks, chewing lice and mosquitoes apply FRONTLINETOP SPOT for Dogs as follows:• To REMOVE Applicator: Lift and remove the plastic tab to exposefoil 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 SPOTP:irt the dog's hair between the shoulder blades. Place the applicatoitip just above the skin and squeeze. Apply entire contents of theapplicator in a single spot directly onto the animal's skin. Do not applyon top of the hair coat. Avoid contact with treated area until dry.FRONTLINETOP SPOT for Dogs is approved for use on breedingpregnant, and lactating bitches and puppies as young as 8 weeks.

* 7 0 0 0 0 0 0 *

FRONTLINE TOP SPOT remains effective even after bathing,water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINETOP 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 three months,however, if there is a high risk of reinfestation or if the dog 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, Rocky Mountain Spotted Fever, ehriichiosis,babesiosis, anaplasmosis and other tick-borne diseases.FRONTLINETOP SPOT kills chewing lice for at least one month.A once monthly application is recommended where chewing licecontrol is needed.FRONTLINE TOP SPOT aids in the control of sarcoptic mangeinfestations. Multiple monthly treatments are recommended for theelimination of mites.FRONTLINETOP SPOT kills mosquitoes within 24 hours for up to 7days, and within 48 hours for up to 28 days with a monthly application.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 puppies 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. If your pet has an unusual reaction to the initialapplication, consult a veterinarian before repeating treatment.Certain medications can interact with pesticides. Consult aveterinarian before using on medicated, debilitated or agedanimals. Call 1-800-660-1842, Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat or open flame.HOW SUPPLIEDFor easy and convenient treatment, FRONTLINE TOP SPOT forDogs is available in sizes for use ONLY on small dogs and puppies8 weeks or older and up to 22 Ibs., medium dogs 23-44 Ibs.. largedogs 45-88 Ibs.. and extra large dogs 89-132 Ibs.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. 65331-3Meriol Limited3239 Satellite Blvd.Duluth. GA 30096-4640, USA©FRONTLINE and TOP SPOT are registered trademarks of Merial.©2011 Merial Limited. Duluth. GA.All fights reserved.

FRONT BACK

Page 11: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …Apr 24, 2012  · • His all life stages of licks (larva, nymph and adult), including brown dog ticks (.• hipicephalus songu/neus)

RONTLINEI )

—11

%•%

To successfully control fleas and tick;, alldogs and cats must be treated with their owndose of FRONTLINE".

v Apply according to label instructions,ensuring the product is applied to the si in,not on top of the fur and not near the collar.It may be helpful to remove the collar beforeapplication, so it doesn't absorb the proluct.

- 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 toapply the entire dose).

-• Even indoor pet; need flea and tick controlbecause you or other pets in the househuldmay bring fleas into the home. These fleascan lead to a flea infestation.

Ticks Chewing

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 stoned using FRONTLINE.

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

50% CM*

The average flea life cycle in thehome is about 21 days long.

To ensure continued protection of yourpets, use 1 hese stickers as a reminderto apply oind re-purchase FRONTLINE.

After treating your pet for the first time,i*1 peel off the sticker and place on your

calendar 1hat day.

OMSTIOHS?Contact your reterinoricnor coll our technicalexperts ot1-800-660-1842,Mondoyf ridoy, 8onv8pm.For more informolion, visitwww.FKOKTUNE.com

6 Monthsuse all 6 stickers

3 Months

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

©FRONTLINE is nregistered trcdernctkofMeriol.©201 IMericJ limited,Duluth, GA.