---
kind: "section"
citation: "21 C.F.R. § 524.1132"
title: "21"
number: "524.1132"
heading: "Hydrocortisone, miconazole, and gentamicin otic suspension."
url: "https://uscodex.org/cfr/21/524.1132"
---

# §524.1132. Hydrocortisone, miconazole, and gentamicin otic suspension.

- (a) **Specifications.** Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
- (b) **Sponsor.** See No.051311 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Instill 1.0 mL in the affected ear once daily for 5 days.
  - (2) **Indications for use.** For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]

### Authority

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

### Source

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

### Amendments

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]