---
kind: "section"
citation: "21 C.F.R. § 524.1044d"
title: "21"
number: "524.1044d"
heading: "Gentamicin and betamethasone ointment."
url: "https://uscodex.org/cfr/21/524.1044d"
---

# §524.1044d. Gentamicin and betamethasone ointment.

- (a) **Specifications.** Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.
- (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—**
    - (i) **Otitis externa.** Instill 3 to 8 drops into the ear canal twice daily for 7 days.
    - (ii) **Infected superficial lesions.** Apply to cover the treatment area twice daily for 7 to 14 days.
  - (2) **Indications for use.** For the treatment of acute and chronic otitis externa and infected superficial lesions caused by bacteria sensitive to gentamicin.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014]

### Authority

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

### Source

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

### Amendments

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014]