Section 524.1001 - Fluralaner and moxidectin(a)Specifications. Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin.(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.(c)Conditions of use -(1)Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.(2)Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, fourth-stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, fourth-stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 85 FR 18120 , Apr. 1, 2020, as amended at 87 FR 58963 , Sept. 29, 2022; 88 FR 14901 , Mar. 10, 2023 85 FR 18120, 4/1/2020; as amended at 87 FR 58963, 9/29/2022; 88 FR 14901, 3/10/2023