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Code · CFR · Title 21 — Food and Drugs · Part 524 — Ophthalmic and Topical Dosage Form New Animal Drugs · § 524.2099

§ 524.2099. Selamectin and sarolaner.

257 words·~1 min read·/us/cfr/t21/s§ 524.2099·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Specifications. Each milliliter
(mL)of solution contains 60 milligrams
(mg)selamectin and 10 mg sarolaner. The drug is provided in single dose tubes containing 0.25, 0.5, or 1 mL of solution.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Conditions of use in cats—(1) Amount. Administer 2.7 mg selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and 0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on the back of the animal at the base of the neck in front of the shoulder blades.
(2)Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections, and the treatment and control of ear mite (Otodectes cynotis) infestations. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for 1 month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [84 FR 12494, Apr. 2, 2019, as amended at 89 FR 14410, Feb. 27, 2024; 90 FR 6801, Jan. 21, 2025]
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