21 C.F.R. § 333.110   First aid antibiotic active ingredients.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—First Aid Antibiotic Drug Products

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§ 333.110   First aid antibiotic active ingredients.

The product consists of any of the following active ingredients within the specified concentration established for each ingredient and in the specified dosage form:

(a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base.

(b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base.

(c) Chlortetracycline hydrochloride ointment containing, in each gram, 30 milligrams of chlortetracycline hydrochloride in a suitable ointment base.

(d) Neomycin sulfate ointment containing, in each gram, 3.5 milligrams of neomycin in a suitable water soluble or oleaginous ointment base.

(e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams of neomycin in a suitable cream base.

(f) Tetracycline hydrochloride ointment containing, in each gram, 30 milligrams of tetracycline hydrochloride in a suitable ointment base.

[52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999]

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