§ 333.103 21 CFR Ch. I (4–1–00 Edition)
the general conditions established in milligrams of neomycin in a suitable § 330.1. ointment base. (b) References in this subpart to reg- (2) Bacitracin-neomycin sulfate-poly- ulatory sections of the Code of Federal myxin B sulfate ointment containing, Regulations are to chapter I of title 21 in each gram, in a suitable ointment unless otherwise noted. base the following: (i) 500 units of bacitracin, 3.5 milli- § 333.103 Definitions. grams of neomycin, and 5,000 units of As used in this subpart: polymyxin B; or First aid antibiotic. An antibiotic-con- (ii) 400 units of bacitracin, 3.5 milli- taining drug product applied topically grams of neomycin, and 5,000 units of to the skin to help prevent infection in polymyxin B; minor cuts, scrapes, and burns. (3) Bacitracin-polymyxin B sulfate [52 FR 47322, Dec. 11, 1987, as amended at 64 topical aerosol containing, in each FR 403, Jan. 5, 1999] gram, 500 units of bacitracin and 5,000 units of polymyxin B in a suitable ve- § 333.110 First aid antibiotic active in- hicle, packaged in a pressurized con- gredients. tainer with suitable inert gases. The product consists of any of the (4) Bacitracin zinc-neomycin sulfate following active ingredients within the ointment containing, in each gram, 500 specified concentration established for units of bacitracin and 3.5 milligrams each ingredient and in the specified of neomycin in a suitable ointment dosage form: base. (a) Bacitracin ointment containing, (5) Bacitracin zinc-neomycin sulfate- in each gram, 500 units of bacitracin in polymyxin B sulfate ointment con- a suitable ointment base. taining, in each gram, in a suitable (b) Bacitracin zinc ointment con- ointment base the following: taining, in each gram, 500 units of baci- (i) 400 units of bacitracin, 3 milli- tracin zinc in a suitable ointment base. grams of neomycin, and 8,000 units of (c) Chlortetracycline hydrochloride polymyxin B; or ointment containing, in each gram, 30 milligrams of chlortetracycline hydro- (ii) 400 units of bacitracin, 3.5 milli- chloride in a suitable ointment base. grams of neomycin, and 5,000 units of (d) Neomycin sulfate ointment con- polymyxin B; or taining, in each gram, 3.5 milligrams of (iii) 500 units of bacitracin, 3.5 milli- neomycin in a suitable water soluble or grams of neomycin, and 5,000 units of oleaginous ointment base. polymyxin B; or (e) Neomycin sulfate cream con- (iv) 500 units of bacitracin, 3.5 milli- taining, in each gram, 3.5 milligrams of grams of neomycin, and 10,000 units of neomycin in a suitable cream base. polymyxin B; (f) Tetracycline hydrochloride oint- (6) Bacitracin zinc-polymyxin B sul- ment containing, in each gram, 30 mil- fate ointment containing, in each ligrams of tetracycline hydrochloride gram, 500 units of bacitracin and 10,000 in a suitable ointment base. units of polymyxin B in a suitable oint- ment base. [52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999] (7) Bacitracin zinc-polymyxin B sul- fate topical aerosol containing, in each § 333.120 Permitted combinations of gram, 120 units of bacitracin and 2,350 active ingredients. units of polymyxin B in a suitable ve- The following combinations are per- hicle, packaged in a pressurized con- mitted provided each active ingredient tainer with suitable inert gases. is present within the established con- (8) Bacitracin zinc-polymyxin B sul- centration and in the specified dosage fate topical powder containing, in each form, and the product is labeled in ac- gram, 500 units of bacitracin and 10,000 cordance with § 333.160. units of polymyxin B in a suitable (a) Combinations of antibiotic active in- base. gredients. (1) Bacitracin-neomycin sul- (9) Neomycin sulfate-polymyxin B fate ointment containing, in each sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 gram, 3.5 milligrams of neomycin and
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