21 C.F.R. § 524.1484i Neomycin sulfate, hydrocortisone acetate, sterile ointment.
Title 21 - Food and Drugs
(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. No. 000009 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Apply three or four times daily into the conjunctival sac. With improvement, frequency may be reduced to two or three times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal one to three times daily.1 (2) Indications for use. For treating infections, allergic, and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats.1 (3) Limitations. All topical ophthalmic preparations containing corticosteroids, with or without an antimicrobial agent, are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of nonsusceptible organisms or to prolonged use on antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian.1 [43 FR 40456, Sept. 12, 1978]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484i Neomycin sulfate, hydrocortisone acetate, sterile ointment.
