---
kind: "section"
citation: "21 C.F.R. § 524.1445"
title: "21"
number: "524.1445"
heading: "Miconazole, polymixin B, and prednisolone suspension."
url: "https://uscodex.org/cfr/21/524.1445"
---

# §524.1445. Miconazole, polymixin B, and prednisolone suspension.

- (a) **Specifications.** Each milliliter of suspension contains 23 milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 mg prednisolone acetate.
- (b) **Sponsor.** See No. 058198 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Instill five drops in the ear canal twice daily for 7 consecutive days.
  - (2) **Indications for use.** For the treatment of canine otitis externa 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

[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]

### Authority

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

### Source

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

### Amendments

[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]