Esafoxolaner, eprinomectin, and praziquantel.

(a) Specifications. Each milliliter (mL) of topical solution contains 12 milligrams (mg) esafoxolaner, 4 mg eprinomectin, and 83 mg praziquantel. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer the entire contents of a provided unit applicator topically once a month at a minimum dose of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and 4.55 mg/lb (10.0 mg/kg) praziquantel. (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations, and the treatment and control of roundworms (fourth-stage larval and adult Toxocara cati ), hookworms (fourth-stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense ), and tapeworms ( Dipylidium caninum ) in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [88 FR 55566, Aug. 16, 2023]