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Antimicrobial Agents are active ingredients used in antimicrobial products. In the U.S., in a final rule published by the U.S. Food and Drug Administration, "OTC Topical Antimicrobial Products," (43 Fed. Reg. 1210, January 6, 1978), an antimicrobial (active) ingredient is defined as "a compound or substance that kills microorganisms or prevents or inhibits their growth and reproduction and contributes to the claimed effects of the product in which it is included," and an antimicrobial preservative (inactive) ingredient is defined as "a compound or substance that kills microorganisms or prevents or inhibits their growth and reproduction and is included in a product formulation only at a concentration sufficient to prevent spoilage or prevent growth of inadvertently added microorganisms, but does not contribute to the claimed effects of the product to which it is added."
In a separate proposed rule, "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products," (56 Fed. Reg. 33644, July 22, 1991), a topical antimicrobial agent is defined, in part, as "an antiseptic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns."
In the EU and other countries, antimicrobial and antiseptic products are considered to be cosmetics, and are controlled under cosmetic regulations which may not require pre-clearance or pre-market approval of active ingredients. In Japan, antimicrobial and antiseptic agents may be regarded as drugs subject to pre-approval requirements.
The listing below includes those ingredients reported to be safe and effective for use in U.S. over-the-counter (OTC) drug products as well as those identified by suppliers as antimicrobial and antiseptic agents. These ingredients may also have a cosmetic purpose in cosmetic formulations.
To identify the currently allowed antimicrobial agents, or for information on ingredient use limitations, etc., the reader is directed to contact the U.S. Food and Drug Administration for the most recent information concerning this drug category.
The U.S. approved drug ingredients are identifed below with a star prefix. Whenever the U.S. drug name differs from the INCI name, the U.S. drug name is presented parenthetically. |