e-CFR data is current as of February 25, 2021 |
Title 21 → Chapter I → Subchapter E → Part 524 → §524.1132 |
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
(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]