21 CFR § 524.1484k Ophthalmic and Topical Dosage Form New Animal Drugs

§ 524.1484k Neomycin and prednisolone suspension.

Current through Sep 8, 2026 · Read all of Part 524

(a) Specifications. Each milliliter of suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. For beginning treatment of acute ocular inflammations place 1 or 2 drops in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis externa, place 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) Indications for use. For the treatment of treating infectious, allergic and traumatic keratitis and conjunctivitis, acute otitis externa, and chronic otitis externa.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014]

← § 524.1484i Neomycin and hydrocortisone ointment.§ 524.1580 Nitrofurazone topical dosage forms. →