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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR524.1001]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1001 Furalaner and moxidectin.

(a) Specifications. Each milliliter of solution contains 280 milligram (mg) furalaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg moxidectin.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis ) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020]

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