{"data":{"id":"us/21-cfr-524.1001","jurisdiction":"us","citation":"21 CFR 524.1001","heading":"Fluralaner and moxidectin.","body":"(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.\n(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.\n(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.\n(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), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.\n(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS","PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"499b04b0a4859000bc75677ff5b3a24baa82789374ce513639b73c87c026c85a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-524.998","next":"us/21-cfr-524.1005"},"notice":"GroundRules: Original legal text. Not legal advice."}