---
kind: "section"
citation: "21 C.F.R. § 524.154"
title: "21"
number: "524.154"
heading: "Bacitracin, neomycin, and polymyxin B ophthalmic ointment."
url: "https://uscodex.org/cfr/21/524.154"
---

# §524.154. Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

- (a) **Specifications.** Each gram of ointment contains:
  - (1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or
  - (2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter as follows:
  - (1) **No.** 054771 for use of product described in [paragraph (a)(1)](#a-1) as in [paragraph (c)](#c) of this section.
  - (2) **Nos.** 000061, 043264, and 086189 for use of product described in [paragraph (a)(2)](#a-2) as in [paragraph (c)](#c) of this section.
- (c) **Conditions of use in dogs and cats—**
  - (1) **Amount.** Apply a thin film over the cornea 3 or 4 times daily.
  - (2) **Indications for use.** Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 88 FR 84701, Dec. 6, 2023]

### Authority

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

### Source

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

### Amendments

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 88 FR 84701, Dec. 6, 2023]