GroundRules
21 CFR 333.110: First aid antibiotic active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—First Aid Antibiotic Drug Products
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON