21 C.F.R. § 524.1484h Neomycin, penicillin, polymyxin, hydrocortisone suspension.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 international units of penicillin G procaine, 5,000 international units of polymyxin B sulfate, 2 milligrams of hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium succinate. (b) Sponsor. See 000009 in §510.600(c) of this chapter. (c) Special considerations. The labeling shall state: This medication contains penicillin. Allergic reactions in humans are known to occur from topical exposure to penicillin. (d) Conditions of use—dogs—(1) Amount. Rub a small amount into the involved area 1 to 3 times a day. After definite improvement, it may be applied once a day or every other day. (2) Indications for use. Treatment of summer eczema, atopic dermatitis, interdigital eczema, and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B. (3) Limitations. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [59 FR 5105, Feb. 3, 1994]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484h Neomycin, penicillin, polymyxin, hydrocortisone suspension.
