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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 524 - Ophthalmic and Topical Dosage Form New Animal Drugs |
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Fluocinolone Topical and Otic Dosage Forms |
§ 524.1484i - Neomycin and hydrocortisone ointment.
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§ 524.1484i Neomycin and hydrocortisone ointment.
(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.
[43 FR 40456, Sept. 12, 1978, as amended at 79 FR 10971, Feb. 27, 2014]