{"data":{"id":"us/21-cfr-524.998","jurisdiction":"us","citation":"21 CFR 524.998","heading":"Fluralaner.","body":"(a) Specifications. Each milliliter of solution contains 280 milligrams (mg) fluralaner.\n(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.\n(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.\n(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.\n(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.\n(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.\n(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.\n(iii) 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":"c918b2014da235de10cb83b904cb058f13914078d8431b6fc382746c3ede5f0b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-524.981e","next":"us/21-cfr-524.1001"},"notice":"GroundRules: Original legal text. Not legal advice."}