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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: 21CFR524.2098]



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. 524.2098 Selamectin.

(a) Specifications. Each milliliter contains 60 or 120 milligrams (mg) of selamectin.

(b) Sponsors. See Nos. 054771, 055529, 061133, and 061651 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer topically 2.7 mg of selamectin per pound (6 mg per kilogram) of body weight.

(2) Indications for use. Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis ), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis ) infestations in dogs and cats. Treatment and control of sarcoptic mange (Sarcoptes scabiei ) and control of tick (Dermacentor variabilis ) infestations in dogs. Treatment and control of intestinal hookworm (Ancylostoma tubaeforme ) and roundworm (Toxocara cati ) infections in cats. For dogs 6 weeks of age and older, and cats 8 weeks of age and older.

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

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, Feb. 27, 2014; 85 FR 18120, Apr. 1, 2020; 85 FR 45308, July 28, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 17064, Apr. 1, 2021]

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