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Electronic Code of Federal Regulations

e-CFR data is current as of December 6, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1132


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§524.1132   Hydrocortisone, miconazole, and gentamicin otic suspension.

(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.

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]

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