21 CFR § 524.1610 - Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.

---
identifier: "/us/cfr/t21/s524.1610"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1610 - Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1610"
section_name: "Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.

(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.

[75 FR 16346, Apr. 1, 2010]