21 CFR 524.1132
§ 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1132, § 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87611
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Full text
(a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
(b) Sponsor. See No.051311 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Instill 1.0 mL in the affected ear once daily for 5 days.
(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.