Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.524.1044g Gentamicin, betamethasone, and clotrimazole ointment

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.

(1) No. 000061 for use of 7.5– or 15–gram (g) tubes, 12.5–, 30–, or 215–g bottles.

(2) No. 054925 for use of 7.5- or 15–g tubes;  10–, 15–, 25–, or 215–g bottles.

(3) No. 069043 for use of 10–, 20–, 40–, or 215–g bottles.

(4) No. 025463 for use of 7.5– or 15–g tubes, or 215–g bottles.

(c) Conditions of use in dogs—

(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.

(i) From 7.5- or 15–g tubes;  10–, 12.5–, 15–, 25–, or 30–g bottles:  4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.

(ii) From 20–, 40–, or 215–g bottles:  2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

(2) Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.524.1044g Gentamicin, betamethasone, and clotrimazole ointment - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-1044g/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard