21 C.F.R. § 524.2098

Current through September 30, 2024
Section 524.2098 - Selamectin
(a)Specifications. Each milliliter contains 60 or 120 milligrams (mg) of selamectin.
(b)Sponsors. See Nos. 051072, 051311, 054771, 055529, 061133, and 086117 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.

21 C.F.R. §524.2098

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; 86 FR 17064, Apr. 1, 2021; 87 FR 58963, Sept. 29, 2022; 89 FR 14410, Feb. 27, 2024; 89 FR 42360, May 15, 2024
85 FR 18120, 4/1/2020; 85 FR 45308, 7/28/2020; 86 FR 13185, 3/8/2021; 86 FR 17064, 4/1/2021; 87 FR 58963, 9/29/2022; 89 FR 14410, 2/27/2024; 89 FR 42360, 5/15/2024