---
kind: "section"
citation: "21 C.F.R. § 524.1484d"
title: "21"
number: "524.1484d"
heading: "Neomycin, hydrocortisone, and tetracaine otic ointment."
url: "https://uscodex.org/cfr/21/524.1484d"
---

# §524.1484d. Neomycin, hydrocortisone, and tetracaine otic ointment.

- (a) **Specifications.** The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of hydrocortisone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.
- (b) **Sponsor.** See No. 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs and cats—**
  - (1) **Amount.** Instill a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily.
  - (2) **Indications for use.** For the treatment of ear canker and other inflammatory conditions of the external ear canal, acute otitis externa and, to a lesser degree, chronic otitis externa.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014]

### Authority

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

### Source

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

### Amendments

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014]