part_subject: "TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
subpart_code: "B"
subpart_subject: "First Aid Antibiotic Drug Products"
section_number: "333.110"
section_subject: "First aid antibiotic active ingredients."
cfr_reference: "21 CFR 333.110"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.