---
kind: "section"
citation: "21 C.F.R. § 524.1144j"
title: "21"
number: "524.1144j"
heading: "Gentamicin, posaconazole, and mometasone furoate otic suspension."
url: "https://uscodex.org/cfr/21/524.1144j"
---

# §524.1144j. Gentamicin, posaconazole, and mometasone furoate otic suspension.

- (a) **Sponsor.** See No. 000061 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter
- (b) **Specifications.** A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.
- (c) **Conditions of use—** This product should be administered by a veterinary professional.
  - (1) **Amount.** The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.
  - (2) **Indications for use.** For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) in dogs.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[90 FR 40970, Aug. 22, 2025]

### Authority

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

### Source

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

### Amendments

[90 FR 40970, Aug. 22, 2025]