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

Bosco Wang FortDodge Animal Health PO Box 5366 Princeton, NJ 08543-5366

Dear Dr. Wang:

DEC 22 2008

OFFICE OF PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

Subject: Amended label to add speed of kill claims for ticks, and instructions for alternate application site at base of skull

ProMeris™ for Dogs EP A Registration No. 80490-2 Your submission dated September 30,2008

The amended label referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act, is acceptable. A stamped copy is enclosed for your records. Submit two copies of your final printed labeling before you release the product for shipment. If you have any questions, please contact Julie Chao at (703) 308-8735 or chao.julie@epa.gov.

Enclosure

Regards,

~ !J"'-'\./....... / 110hn Hebert l-/" Inse~tici~e-Ro?e.n~icide Branch

RegIstratIOn DiVISIon (7505P)

ACCEPTED DEC 222008

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

pesticide registered under:

EPA. Reg. No: 8 O¥i 0 -2-

PrOMeris® for dogs

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Fort Dodge Animal Health A division of Wyeth

t!/JI/IIIJ Pr()f\1pris· 70; dogs Fartl:/oaolAnimltHllllth

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Single spot applitalio. for control of lleas, ticles, cbewing lice ... d Demodectic mange miles on dogs and puppies 8 weeks of age and older.

ACTIVE INGREDIENTS: MetoIIumizOllll (CAS No. 139968-49-31' .................................................................. 14.34% Amitraz (CAS No. 33089-61.11 ............................................................................... 14.34%

OTHER INGREDIENTS ............................................................................................................... 71.3Z% TOTAL.. ............................................................................................................ 1 00.00%

KEEP OUT OF REACH OF CHILDREN CAUTION

READ ENTIRE LABEL BEFORE USE For oontroI of fleas (Ctenocephalides spp.), ticks, chewing lice and Demodectic mange mites on dogs and puppies 8 weel:s of age and older. ProMeme for dogs is " convenient single spot applicationthatprovidescontrolofexistingflea, tick,chewinglice and Demodecticmangemite infestations, and proteCl$ againsl rein!es1alion of fleas, ticks andchewingfice. tt may alsabeused to prevent intestation in flea free dogs and puppies 8 weeks of age and older taken into a Dea-contaminated environment Kills neas that may cause flea alleflJY dermatitis. Kills and controls the following ticks, lice and mange mites:

• Black·legged or deer ~cks (Ixodes scapularis), which can tlansmit lyme disease • Brown dog ticks (Rhipicepllaills sanguineusl, which can transmit Ehrfichia canis • Ameriain dog ticks (DeITll8Cl!l1tOlvariabilis), which can transmit Rocky Mountain Spotted Fever • lone slar ticks (Ambttumma americanum), which can transmit Ehrfichia chalfaensis • Chewing lice (Trichodectes canis) • Demode. mites (Oemodex spp.), which can cause Demodectic mange

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Start killing ticks within 4.hcurs. Rapidly kiUs most tick species within 24 hclllS.

ProMeri.,~ lor dogs can be used in breeding males, as well as breeding and pregnant bitches. Do not use on lactating/nlllSing bitches until at least 5 days after delivery.

A single dose of ProMeris' lor dogs is effuctive for up to 6 weeks in controDing fleas and up to 4 weeks for ticks. Apply a single dose prior to exposure. Monthly application is recommended for effuctive control of fleas, ticks, chewing lice and Demodectic mange mites and to prevent reinfestation of fleas, ticks and chewing lice. Do not apply more than once monthly. ProMeris" for dogs contains two active ingredients - metaflurimone and amitraz. Metaflumizone provides a high level of control of fleas and chewing lice by blocking gated sodium cbannels. Amitraz provides oontroI of ticks and Demodectic maoge mites by affecting octopamine receptors.

Benefits of I'rDMorls" for dogs include: 'Stops and controls infestations oflleas, ticks. chewing lice and Demodectic mange mites • Prevents reinfes1ation of fleas, ticks and chewing lice • Up to 6 weeks of flea control with a singte treatment • Kills flea. that may cause flea allergy dermatitis • Up to 4 weeks of tick control with • single treatment 'Kills tick'.that may tlansmit Lyme disease, canine eMichiosis or Rocky Mountain Spotted Fever

including brown dog ticks, American dog ticks, lone sIlIr ticks, and blacl<-1egged or deer ticks ·Starts killing ticks within 4 hDUr$ -Rapidly kills most tick species within 24 hours - Kills chewing lice • KiDs mites that may cause Dernodectic mange 'Convenient and easy to use applicator ·Waterproof 'Effective on indoor or outdoor dogs • Ava~able only from a licensed veterinary PfOfessionai - Pleasant eucalyptus smell

DIRECTIONS FOR USE

tt is a violation of Fedend law to use this product in a manner inconsistent with its labeling. For external us. on dogs and puppies 8 weeks of age and older. DO NOT USE ON ANV ANIMALS oniER THAN DOGS.

PACKAGING

ProMerise lor dogs is available in fIVe packaging presentations for different body weights of dogs and puppies 8 weeks of age and older (see table below). Each package contains three or six individual applicator tubes to provide monthly treatments. The dog body weight 6mits and product volume sizes are specified on individual labels of cartons, foil pouches and applicators.

PaclIage DogSize(lbs} A. Dl/applicator

XS Dogs 11 pounds and under (" 111 0.023

S Dogs over 11 and up to 22 pounds (> 11·22) 0.D45

M Dogs over 22 and up to 55 pounds (>22·55) 0.113

L Dogs over 55 and up to 88 pounds (>55-881 0.180

Xl Dogs over a8 and up to 110 pounds (>88·110) D.ll5

HOW TO APPLY

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1. Remove one applicator from the foil pouch. 2. Hold appficator upright for three seconds to avoid splash when opening.

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3. Use two hands to hold both ends of appficator with printed side facing the user and narrow end pointing upward and away from the user.

4. To open, bend the tip of applicator towards 111. user and break along the fracture line. 5. Do not squeeze applicator when opening. Avoid touching applicator opening. 6. Fold tip back against the printed side of appticator. Hold appticatcr in one hand using thumb

to hold tip back against the printed side of applicator. 7. PIJoh the open tip through dog's hair coat onto dog'. skin ot the base of the sM or between the

shoulder blades. Squeeze applicator to apply the entire contents to the dog's skin. Do not apply on the sutfaca of dog's haiicoat Avoid contact with treated area until dry.

8. Avoid allowing the product to come in contact with your skin. 9. Place empty appticator in trash.

STORAGE AND DISPOSAL

Do not contaminate water, food, or feed by storage or disposal. Storage: Store in a cool dry place. Container Disposal: ~: Do not reuse thiS container. Placa in trash or offer for recycling ~ available. . ~: can your local solid wasla agency fo, disposal instruction. Never place unused pr down any indoor or outdoor drain.

ARST AID FOR HUMANS

Have the product applicator, carton or this product label with you when contacting a poison control center or medical professional. W swallowed, caD a, poison oontroI center or doctor immediately for treatment advice. Have person sip a glass of water if able to sweIIow. Do not induce vomiting unless toid to do so by a poison control center or medical professional. Do not give anything to an unconscious p=

PRECAUTIONARY STATEMENTS

Hazards to Humans

CAUTION Harmful if swallowed. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco.

Hazanls to Domestic Animals For external use only. For use on dogs only. DO NOT USE ON Atf( ANiMAlS OTHER THAN DOGS. Do not use on puppies younger than 8 weeks of age. Certain medications can interact with pesticides. Consutt a veterinarian before using this product on aged, debilitated or medicated animals. Individual sensitivities,whilerare,mayocculaftertheuseofanypesticideproduclWskinirritation,changeinbeltavior, vomiting or dia1l!1ea is obselVed and persists after the use of the product, can your veterinarian immedis1ely. For further ploduct infannation,calll-8BB-l'ROMERIS (1-888·776--6374).

Physical and Cbemical Hazanls Combustible. Do not use or store near heat or open flame.

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UMITED WARRANTY AND DISCLAIMER

Directions fOI use of this product are based upon tes1s befieved to be reliable. The use of this product being beyond cordrol of the seller, no guarantee, express or implied, is made as to the enects of such use or the results to be obtained ~ not used in accordance with printed direction. and es1ablished safe practice. To the extent consiStent with app~cable law, buyer's exclusive remedy and seller's exclusive tiability for any and aU claims, losses, damage. or injuries resulting from the use or handling of thiS pro­duc~ whether or not based in contract, negligence, slrict liability in tort 01 otherwiSe shall be limited, at the seller's option, to replacement of, or the repayment of the purchase price for, the quantity of product with respect to which damages are claimed.

Fort Dodge Animal Heatth P.O. Box 25945 OVerland Pari<, KS 66225

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