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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1484h


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


§524.1484h   Neomycin, penicillin, polymyxin B, and hydrocortisone suspension.

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

(c) Conditions of use in dogs—(1) Amount. Rub a small amount into the affected area 1 to 3 times a day. After definite improvement, apply once daily or every other day.

(2) Indications for use. For the treatment of summer eczema, atopic dermatitis, interdigital eczema, and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B.

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

(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, as amended at 79 FR 10971, Feb. 27, 2014]

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