---
kind: "section"
citation: "21 C.F.R. § 524.981e"
title: "21"
number: "524.981e"
heading: "Fluocinolone and dimethyl sulfoxide otic solution."
url: "https://uscodex.org/cfr/21/524.981e"
---

# §524.981e. Fluocinolone and dimethyl sulfoxide otic solution.

- (a) **Specifications.** Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.
- (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—**
  - (1) **Amount.** Instill 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters.
  - (2) **Indications for use.** For the relief of pruritis and inflammation associated with acute and chronic otitis.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[79 FR 10969, Feb. 27, 2014]

### Authority

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

### Source

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

### Amendments

[79 FR 10969, Feb. 27, 2014]