21 C.F.R. § 333.110

Current through October 31, 2024
Section 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.

21 C.F.R. §333.110

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