Food and Drug Administration, HHS § 333.120 contain information allowed for health the general conditions established in professionals for antacids and anti- § 330.1. flatulents. (b) References in this subpart to reg- ulatory sections of the Code of Federal PART 333—TOPICAL ANTI- Regulations are to chapter I of title 21 MICROBIAL DRUG PRODUCTS unless otherwise noted. FOR OVER-THE-COUNTER § 333.103 Definitions. HUMAN USE As used in this subpart: First aid antibiotic. An antibiotic-con- Subpart A [Reserved] taining drug product applied topically to the skin to help prevent infection in Subpart B—First Aid Antibiotic Drug minor cuts, scrapes, and burns. Products [52 FR 47322, Dec. 11, 1987, as amended at 64 Sec. FR 403, Jan. 5, 1999] 333.101 Scope. 333.103 Definitions. § 333.110 First aid antibiotic active in- 333.110 First aid antibiotic active ingredi- gredients. ents. 333.120 Permitted combinations of active in- The product consists of any of the gredients. following active ingredients within the 333.150 Labeling of first aid antibiotic drug specified concentration established for products. each ingredient and in the specified 333.160 Labeling of permitted combinations dosage form: of active ingredients. (a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in Subpart C—Topical Antifungal Drug a suitable ointment base. Products (b) Bacitracin zinc ointment con- 333.201 Scope. taining, in each gram, 500 units of baci- 333.203 Definitions. tracin zinc in a suitable ointment base. 333.210 Antifungal active ingredients. (c) Chlortetracycline hydrochloride 333.250 Labeling of antifungal drug prod- ointment containing, in each gram, 30 ucts. milligrams of chlortetracycline hydro- 333.280 Professional labeling. chloride in a suitable ointment base. (d) Neomycin sulfate ointment con- Subpart D—Topical Acne Drug Products taining, in each gram, 3.5 milligrams of 333.301 Scope. neomycin in a suitable water soluble or 333.303 Definitions. oleaginous ointment base. 333.310 Acne active ingredients. (e) Neomycin sulfate cream con- 333.320 Permitted combinations of active in- taining, in each gram, 3.5 milligrams of gredients. neomycin in a suitable cream base. 333.350 Labeling of acne drug products. (f) Tetracycline hydrochloride oint- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, ment containing, in each gram, 30 mil- 360, 371. ligrams of tetracycline hydrochloride in a suitable ointment base. SOURCE: 52 FR 47322, Dec. 11, 1987, unless otherwise noted. [52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999] Subpart A [Reserved] § 333.120 Permitted combinations of active ingredients. Subpart B—First Aid Antibiotic The following combinations are per- Drug Products mitted provided each active ingredient is present within the established con- § 333.101 Scope. centration and in the specified dosage (a) An over-the-counter first aid anti- form, and the product is labeled in ac- biotic drug product in a form suitable cordance with § 333.160. for topical administration is generally (a) Combinations of antibiotic active in- recognized as safe and effective and is gredients. (1) Bacitracin-neomycin sul- not misbranded if it meets each of the fate ointment containing, in each conditions in this subpart and each of gram, 500 units of bacitracin and 3.5 229 VerDate Mar<15>2010 14:38 May 22, 2013 Jkt 229072 PO 00000 Frm 00239 Fmt 8010 Sfmt 8010 Y:\SGML\229072.XXX 229072 emcdonald on DSK67QTVN1PROD with CFR.