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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter EPart 524 → §524.1484i


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


§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]

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