(a) Specifications. The product is supplied in two vials, one vial containing 2.51 grams of sterile fluralaner and one vial containing the required 15 milliliters (mL) of sterile vehicle for constitution. Each mL of constituted suspension contains 150 milligrams (mg) fluralaner.

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

(c) Conditions of use—(1) Amount. Administer as a single subcutaneous dose every 12 months or every 8 months in the case of potential exposure to Amblyomma americanum ticks. The subcutaneous dose volume is 0.1 mL of the constituted suspension/kilogram (kg) body weight (0.045 mL per pound (mL/lb)). This volume provides a dose of 15 mg fluralaner per kilogram body weight (6.8 mg/lb).

(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); for 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 months in dogs and puppies 6 months of age and older; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.

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