---
kind: "section"
citation: "21 C.F.R. § 524.2338"
title: "21"
number: "524.2338"
heading: "Terbinafine and betamethasone acetate."
url: "https://uscodex.org/cfr/21/524.2338"
---

# §524.2338. Terbinafine and betamethasone acetate.

- (a) **Specifications.** Each milliliter of gel contains 10 milligrams (mg) terbinafine and 1 mg betamethasone acetate.
- (b) **Sponsor.** See No. 043264 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
  - (2) **Indications for use.** For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[89 FR 42360, May 15, 2024]

### Authority

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

### Source

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

### Amendments

[89 FR 42360, May 15, 2024]