{"data":{"id":"us/21-cfr-524.1610","jurisdiction":"us","citation":"21 CFR 524.1610","heading":"Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.","body":"(a) Specifications. Each gram of suspension contains 10 milligrams (mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole.\n(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.\n(c) Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 lbs. instill 4 drops once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy should continue for 7 consecutive days.\n(2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).\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":"2f3739491d078d66b1ae022d0babe23a345daf5c3fc95d3cef37e8b0ec851b51","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-524.1600b","next":"us/21-cfr-524.1662"},"notice":"GroundRules: Original legal text. Not legal advice."}