---
kind: "section"
citation: "21 C.F.R. § 524.1610"
title: "21"
number: "524.1610"
heading: "Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension."
url: "https://uscodex.org/cfr/21/524.1610"
---

# §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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[75 FR 16346, Apr. 1, 2010]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

### Amendments

[75 FR 16346, Apr. 1, 2010]