21 CFR §524.998

(a) Specifications. Each milliliter of solution contains 280 milligrams (mg) fluralaner.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks. (ii) Indications for use. Kills adult fleas; 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 Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to D. variabilis ticks. (ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis) and the treatment and control of I. scapularis (black-legged tick) and Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater; for the treatment and control of D. variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.