Topical Antimicrobials & Antiseptics

What are Topical Antimicrobials and Antiseptics?

Personal care products containing antibacterial ingredients are sometimes referred to as topical antimicrobial products (sometimes also called consumer antiseptics). Antimicrobial products are critical to public health because of the importance personal hygiene plays in preventing infection. Antimicrobial products such as hand soaps also provide an important measure of protection for food service personnel and doctors and nurses in health care settings by preventing the spread of germs.

How Are Antimicrobial Personal Care Products Regulated in the U.S.?

Antimicrobial personal care products are regulated by the U.S. Food and Drug Administration (FDA) as Over-The-Counter (OTC) Drugs. Consumer preference for antimicrobial protection has led to an array of topical antimicrobial personal care products such as consumer antiseptics in the form of hand and body washes.

Dental Products – Antimicrobial dental products (regulated by FDA as OTC anti-gingivitis drug products) are formulated to reduce bacteria in the mouth that may ultimately lead to gum disease. Antimicrobial toothpaste and mouthwash may help prevent plaque and gum diseases such as gingivitis.

Consumer Hand and Body Washes – When such products contain an antimicrobial ingredient and are marketed for consumers, FDA refers to them as ‘Topical Antimicrobial OTC Drug Products: Consumer Antiseptics.’ On September 6, 2016, the FDA issued a final rule on the ‘Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.’ FDA concluded that consumer antiseptic products intended for use with water (including antibacterial soaps, hand washes, and body washes) that contain any of 19 specific active ingredients can no longer be marketed. The FDA concluded that manufacturers had not adequately demonstrated products containing these ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Prior to the FDA ruling, some manufacturers had already started removing these ingredients from their products.

In response to comments submitted by manufacturers, the FDA deferred rulemaking on three specific ingredients– benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX) – to allow manufacturers to develop and submit new safety and effectiveness data. Consumer antibacterial washes containing these specific ingredients may continue to be marketed during this time while data are being collected.

Hand Sanitizers and Wipes and Antiseptic Products Used in Healthcare Settings

In separate rulemakings, FDA is proposing conditions under which OTC consumer antiseptic rubs (products that are not rinsed off after use, including health care antiseptics (80 FR 25166), consumer antiseptic rubs (81 FR 42912), antiseptics identified as “first aid antiseptics” in the 1991 First Aid Tentative Final Monograph (56 FR 33644), or antiseptics used by the food industry) and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital (80 FR 25166, May 1, 2015) are generally recognized as safe and effective.

More information:

FDA Code of Federal Regulations

European Union (EU)

Annex V – preservatives allowed for use in cosmetics sold in the EU