(a) Specifications. Each chewable tablet contains 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).

(2) Indications for use. Kills adult fleas, and for the treatment of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.