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1/~8/ aoo8' ·c. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

Bosco Wang Fort Dodge Animal Health POBox 5366 Princeton, NJ 08543-5366

Dear Dr. Wang:

January 28,2008

Subject: Submission of revised label ProMeris for Cats EPA Registration No. 80490-3 Your submission dated December 5, 2007

OFFICE OF PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

The amended label referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide; and Rodenticide Act, is acceptable with the following comments:

The proposed uses of "exclusive," "novel," ''unique,'' and/or "innovative" to replace the wor.d "new" are not acceptable. The phrase ''The only metaflumizone-based product for flea control in cats" is not acceptable. These qualifiers imply that the product possesses unique characteristics because of its composition, and are only permissible during the 6 months following approval of the labeling for a new composition. Therefore, remove the· word "new" from the label. The phrase "Mode of Action - voltage dependent sodium channel blocker" may be retained.

A stamped copy is enclosed for your records. Submit two copies of your final printed labeling before you release the Produ9t for shipment. If you have any questions, please Julie Chao at (703) 308-8735 or chao.julie@epa.gOv.

Enclosure

Regards,

secticide-Rodenticide Branch . Registration Division (7505P)

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Fort Dodge intends this product to be sold only by veterinarians

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Fort Dodge may Institute appropriate legal action If this

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DIRECTIONS FOR USE II is' a violation of Federal law to use this product, In- a manner inconsistent with Its labeling. See' Inside: pamphlet for label information and dltectionsfor use. Read the entire Iabe~ dlredlons for use and -How;to Apply" InstrUCtions before usi~. the prodiJct each .ti me~ For use on cats only.

For control offleas (CtJJnocephalldes sp.) apply the entire . contents of the applicator to a single spot on· the skin of­the cat below the back c1 the head. DonCl applyon:the . surface of cat's hair coat. Avoid contact with treat&d area urd dry. Avoid allowing the pro<iJct to come '(ncontact with VOlI' sldn. Place empty applicator In trash. Monthly application Is recommended for effective,control. of fleas and to prevent reinfestation where there Is a high risk of reinfestation or if the cat is susceptible to. flea aOergy dermatitis. • Use the Small cat 8pplcator for all kittens between 8 weeks and 6 months of age.

For moralrlormatfol\ contact your vetllrfnarfan or caD 1he ProMeds" tor cats Consumer Halplile

at 1-888-fROMERlS (1-888-176-6374)

FortDodge Arirnal H~ p.o. Sax 26945 Overland Park. KS 66225

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Fort Dodge Intends this product to be $Old only by veterlnarlana

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DIRECTIONS FOR USE k is a violation of Federal law to use ,this prOduct in a manner inconsistell with its labefmg. See inside' pampNer for label Information and dii'ectionsfor use: Read the entire label, directions tor use aoo "I'fow to Apply" Instructions before using the product each time. For use on cats only.

For conD'd offleas (QenocephaildeS'Sp.) aJlPly'1heentire corte ItS of the applfc«or to a singe sp(X on theskinot the cat below the back of the head. Do not apply on IDe surfaoe of cat's hair coat Avoid contact with treated a-ea UftII dry. Avoid aIIowIllJ the product to come lil conta12 with your skin. Aace empty SR>Iicetor in trash. MontHy appicatiatls recommendlidtot effective comol oflleas aoo to prevell relnfestation where there is a'hlgh risk d reinfe&1ation or if the cat is suscep~bleto flea allergy dennatitis. -• Use the Small Cat applicator for aU kittens betWeen 8 weeks and 6 months of ~e.

For more Information, contact your veterinarian or call the ProM8ris'" 10, cats Consumer Helpline

at 1-888-PROMERS (1-888-716-6.174)

Fan Dodge Animal Health P.O. Bax25945

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~: ,:SOrer (I .. J DIRECTIONS FOR USE It fs a violation of Federal law to use this productln a· manner lneanslstem with its labeling. See· inSide pamphlet for label information an~ directions for use., . Read the entire Iabe~ directions for use and "HoW to Apply"' instructions before usi~ the product each time. For use on cats only.' .

For cOlllrol of fleas (Ctenocephalides sp.) apply me 'enJire . cootents of the applicator to a single spot on the skin bf the cat below the back cI the head. 00 n<l apply on'the­surface of cat's hair coat. Avoid contact with treated area until dry. Avoid allowing the product to come Incootact with your skin. Place empty applICator In trash: Monthly application Is recommended.for effectiVe,corltroL of flea; and to prevent reinf8Slation where there is a hi{jh risk of reinfestatlon or if the cat is:susceptible<to flea anergy dermati1is. . Use the Small Cat applicator for all kittens between 8~ weeks and 6 mooths cI age.

For more iriormatiol\ contact yow veterinarian or call theProMetls no tol cats Consumer Helpline

at 1-888-PROMERIS (1.a8-77U314J

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l.argI cats (L J Bibs and Dver. ' : '.

DIRECTIONS FOR USE It Is a violation of Federal law to use this proouct In·a manner inconsistent with its IabeHng.· See lnsif8 P8flllhIet for labellnfonnadon and directions tor. use.

. Read th!! entire label. directions for use and. "How to Apply" Instructions before using the product each·time.: For lIIe on cats only.

For control of fleas (Qenocephalldes spJ,appy thnntire CUltan1S of the appDcator to a single Spot on the skin. of 'the cat below the back of the head. 00 not apply 00. the surface of cat's hair coat Avoid tontact with treated area urd dry. Avoid allowing the produtt to come in conraci W:iIh yotI' skin. Place empty ~pRcator in trash. .Monthly application Is recommended for effective control oHJeas and to prevent.reinfeslation where there'ls a high risk of reinfestation or If the cal is Sl6ceptl~e to flea allergy dermatitis. Use the smau ell applcator for aU kittens between 8. weeks and 6 months of age.

For morelnfonnadon, contact your vet8r1narlan or caa the PmMw" torclD Consumer H~lint

at 1-888-PROMERIS (1-888-176-6314)

Fon Dodge Animal Heakh P.o.Sox259E Oveltand Part, KS 66226

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PrOMerism

for cats

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Fort Dodge Animal Health A division of Wyeth

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PrCMeris- t!I8I for cats Fort Dodge AnImaI_

SiIqjle spot applicatloo for control of fie .. on cats and kittens 8 weeks of ago and ohIor.

AC11VE INGREDIENT: MataflumizoDe (CAS No. 139968-49-31·······.· .• __ .• __ .. ____ •••• _ ..•• _ •..• _ •.•. __ .•••.•. _18.53%

01HER INGREDIENTS ._ •• _ •• : •• _ ••••••• __ •• _ •• _._ ••••••••••••••••••••• __ •• _ •••••••••••••••• - •••..• _ •..• ..J1.!D1 TOTAL __ •• _. __ •.. __ •.••• _________ • _________ •• ____ .• __ •• _ .• _. __ •.•. _ •• _. ___ .. 100.00%

KEEP OUT OF REACH OF CHILDREN CAUTION

READ ENTIRE LABEL BEFORE USE For control of fleas (CIsnoI;ephslidas sp.) on cats and kittens 8 weaks of ago and oldor. ProMeris ~ for C8ts is a convenient single spot application that provides control of existing nea infestations. and protects against reinfestation. It may also be used to prevent infestation in flea-fre8 cats and kittens 8 weeks of age and older taken into 8 flea-contaminated environment Kills fleas that may cause flea allergy dennatitis.

A single dose of ProMeris -for cats is effective for up to 7 weeks in controlling fleas. Apply a single dose prior to exposure. Reapplication at monthly intervals may be appropriate d.pending upon the level of nea challenge and animal sensitMtias (i.a. flea anargy dermatitisl· Do not apply more than once monthly.

ProMeris ~for cats contains tha active ingredi.nt, metafiwnizone, which providas a hillh lev.1 of control of fleas by blocking galBd sodium channels.

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Benefits of ProM.tis ~f.r co,. includo: • Stops and controls infestations of fleas • Prevents reinfestation of fleas

r-:.Lonq-lastinq.controlJor.up.to 7 we.ks __________ . _

'. +J~.~:of:aclioi1'-';~~dependent sodium chinneI bIncbr \.:: •. 1GIs fIeas.that may cause flea alletgj dennatitis

• Convenient and easy to use applicator . • Available only from a licensed veterinary professional

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. For external USa on cats and kitt.ns 8 waeks of ago and old .... DO NOT USE ON MfY

ANIMALS OTHER THAN CATS.

PACKAGING

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ProMerisNfor cats is available in two packaging presentations for different body weights of cats or kittens 8 weeks of 0119 and older (s •• table belowl. Each package contains one, three or six i",flVidual app6cator tub.s to provlda monthly treatm.nts. Tha cat body weight limits and product volume sizes are specified on individual labels of cartons, foil pouches and applicators.

·Use the Small Cat appHcator lor all kittens between 8 weeks and 6 months of age

HOW TO APPLY

[Ij~~~ 1. Remove one applicator from the foil pouch. 2. Hold appficator upright forthree s.conds to avoid splash when opening. 3. Usa two hands to hold both ands olapp6cator with printed side lacing the user and narrow

end pointing uPward and away from the user. 4. To opan, bend the tip of applicaw towards the user and break along the lracture fino. 5. Do not squaaze applicator wh.n opening. Avoid touching applicator opening. 6. Fold tip back against the printed side of applicator. Hold applicator in Dna hand using thumb

to hold tip back againsttha printed sida of applicator. 7. Push the open tip through cafs hair coat onto cafs skin below the back oftha haad. Squeeze

applicator to apply tho entire contents to the cat's skin. Do not apply on tho sulface of cat's hair coat Avoid contact with treated area until dry.

8. Avoid aDowing the product to come in contact with your sldn. 9. Placa empty appficator in trash.

STORAGE AND DISPOSAL

Do not contaminate water. food. or feed by storage or dispos1ll. Storago: Store In a cool dry place.

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C_erDisposat ~ Do not reuse this container. Place in trash or offer for recycling it available. ~ Call your local rofid wast. agancy for disposal instruction. Nev.r placa unus.d product down any indoor or outdoor drain .

FIRST AID FOR HUMANS

Have the product applicator, carton Dr this product label with you when contacting a poison contrOl center or medical professional. H in eyes, hold eyes open and rinse with water for 15 to 20 minutes. II contact lens is present remove contact lens after the first five minutes of rinsing, then continue rinSing eyes. CaU a poison control center or doctor for treatment advice.

PRECAUTIONARY STATEMENTS

Hazards to Humans

Causes mod.rate eyo irritation. Avoid contact with eyes, skin Dr clothing. Wash thoroughly with soap and water after handling.

Hazards t. Domestic Animals

For external us. only. FOR USE ON CATS ONLY. Do not use on kittens younII9rthan 8 woe'" of age. Care should be talcen to apply as directed to minimize the chanc. 01 accidental ingestion by the cat. Exposure or ingestion may result in temporary salivation; this response should disappear without treatment. ColTBClapptication of the product wiD reduco the chances of oral exposure. Certain medications can Interact with pesticides. Consult a veterinarian before using this product on ag9d, debilitated, medicated, prognant or nursing animals. Individual sensitivi­ties. while· rare, may occur after the use of any pesticide product If skin'irritation. change in behavior, vomiting or dianhea is obselV.d and p.rsists after the use of the product. call your veterinarian irrunediately. .

-FililUi1l1ili jlrilduct ii1I1II111ation, catn:88j:liIiOMERlSlNi88·77&=6374) .

Physical and Chemical Hazard.

Combustible. Do nat use or store near heat Dr open flame.

UMITED WARRANTY AND DISCLAIMER

Directions for use of this product are based upon tests bafieved to be reliable. The use of this product being beyond control of the seller, no guarantee. express or inipfied. is mad. as to the effects of such usa or the results to ba obtained if not used in accordanco with printed directions and established safa practice. To the extent consistont with applicable law, buy.fs exclusive remedy and seD .... exclusive liability for any and aD claims, losses, damages or ;njurias resulting from the use or handfing of this product. whether or not based. in contract. naglillence. strict liabirrty in tort or otherwise shall be limited, at the seller's option, to replacament of, or the repayment of tho purchase price for, the quantity of product with resp.ct to which damages are claimed.

Fort Dodge Animal Health P.O. Box 25945 Overland Pa"" KS 66225

MADE IN ITALY

CZOO6 Fort Dodge ArimaI HRIIh.. clvision alWyath. All rillhts morved

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