---
kind: "section"
citation: "21 C.F.R. § 524.1312"
title: "21"
number: "524.1312"
heading: "Marbofloxacin, terbinafine, and dexamethasone otic suspension."
url: "https://uscodex.org/cfr/21/524.1312"
---

# §524.1312. Marbofloxacin, terbinafine, and dexamethasone otic suspension.

- (a) **Specifications.** Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.
- (b) **Sponsor.** See No. 043264 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration.
  - (2) **Indications for use.** For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) 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]