---
kind: "section"
citation: "21 C.F.R. § 524.802"
title: "21"
number: "524.802"
heading: "Enrofloxacin and silver sulfadiazine otic emulsion."
url: "https://uscodex.org/cfr/21/524.802"
---

# §524.802. Enrofloxacin and silver sulfadiazine otic emulsion.

- (a) **Specifications.** Each milliliter contains 5 milligrams (mg) enrofloxacin and 10 mg silver sulfadiazine.
- (b) **Sponsors.** See Nos. 058198 and 069043 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—** Dogs—(1) Amount. 5 to 10 drops for dogs weighing 35 pounds (lb) or less and 10 to 15 drops for dogs weighing more than 35 lb; applied twice daily for up to 14 days.
  - (2) **Indications for use.** For the treatment of otitis externa in dogs.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

## Notes

### Amendments

[65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021; 89 FR 85428, Oct. 28, 2024]

### Authority

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

### Source

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

### Amendments

[65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021; 89 FR 85428, Oct. 28, 2024]