21 CFR 524.1610
§ 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1610, § 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87646
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Full text
(a) Specifications. Each gram of suspension contains 10 milligrams (mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(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.
(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).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.