Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
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§ 524.1146 Imidacloprid and moxidectin.
(a) Specifications —(1) Each milliliter of solution contains 100 milligrams (mg) imidacloprid and 25 mg moxidectin for use as in paragraph (d)(1) of this section.
(2) Each milliliter of solution contains 100 mg imidacloprid and 10 mg moxidectin for use as in paragraph (d)(2) of this section.
(b) Sponsor . See No. 000859 in §510.600(c) of this chapter.
(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 . 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 ).
(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 ).
[72 FR 10597, Mar. 9, 2007]
