subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "524"
part_subject: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "524.1484i"
section_subject: "Neomycin and hydrocortisone ointment."
cfr_reference: "21 CFR 524.1484i"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. The drug contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams of hydrocortisone acetate in each gram of ointment.1
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs and cats—(1) Amount. Apply 3 or 4 times daily into the conjunctival sac. With improvement, frequency may be reduced to 2 or 3 times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal 1 to 3 times daily.
(2)Indications for use. For the treatment of infections, allergic and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.