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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 Jul 20, 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: 21CFR524.1146]



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. 524.1146 Imidacloprid and moxidectin.

(a) Specifications. Each milliliter of solution contains:

(1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or

(2) 100 mg imidacloprid and 10 mg moxidectin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:

(1) Nos. 017030, 058198, and 061651 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.

(2) Nos. 051072, 017030, 058198, and 061651 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

(3) Nos. 051072 and 058198 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(3) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use - (1) Dogs - (i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month.

(ii) Indications for use. (A) For the prevention of heartworm disease caused by Dirofilaria immitis ; and the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina ), hookworms (Ancylostoma caninum and Uncinaria stenocephala ), and whipworms (Trichuris vulpis ); kills adult fleas and treats flea infestations (Ctenocephalides felis ).

(B) For treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis.

(2) Cats - (i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis ; for the treatment and control of ear mite (Otodectes cynotis ) infestations, intestinal roundworms (Toxocara cati ), and hookworms (Ancylostoma tubaeforme ); kills adult fleas and treats flea infestations (Ctenocephalides felis ).

(3) Ferrets - (i) Amount. Topically apply 9.0 mg/lb body weight (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis ; kills adult fleas (Ctenocephalides felis ) and is indicated for the treatment of flea infestations on ferrets.

[72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 86 FR 61686, Nov. 8, 2021; 87 FR 17946, Mar. 29, 2022]

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