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Antimicrobial soap, also sold as antibacterial soap, is a wash product that adds an antimicrobial active ingredient to ordinary soap. Since 2017 US rules have barred 19 such ingredients, including triclosan and triclocarban, from over-the-counter consumer washes, and FDA found no evidence that they work better than plain soap and water. This page is general product information, not medical advice.
Short answer
Antimicrobial soap is a hand wash, body wash or bar soap marketed as killing or reducing germs because it contains an added antimicrobial ingredient. In the United States, FDA’s 2016 final rule removed 19 active ingredients from nonprescription consumer antiseptic washes because manufacturers had not shown they were safe for long-term daily use or more effective than plain soap and water. The rule does not cover hand sanitizers, hand wipes, or antibacterial soaps used in health-care settings.
Definition and scope
FDA’s guidance applies the term to products intended for use with water and rinsed off after use, including consumer hand washes and consumer body washes. Its question-and-answer document describes these as “antibacterial soaps, antibacterial hand washes, and antibacterial body washes.” The final rule was published on 6 September 2016 (81 FR 61106) and took effect on 6 September 2017.
Products containing one of the 19 named ingredients are misbranded and are considered new drugs that would need an approved application to be marketed as consumer washes. FDA’s consumer update states that liquid, foam and gel hand soaps, bar soaps and body washes are all in scope.
Antimicrobial soap ingredients: which are removed, which are deferred
The 2017 FDA guidance names the 19 ingredients: cloflucarban, fluorosalan, hexachlorophene, hexylresorcinol, iodophors (iodine complex, nonylphenoxypoly(ethyleneoxy)ethanoliodine, poloxamer-iodine, povidone-iodine and undecoylium chloride iodine complex), methylbenzethonium chloride, phenol, secondary amyltricresols, sodium oxychlorosene, tribromsalan, triclocarban, triclosan and triple dye.
Three further ingredients, benzalkonium chloride, benzethonium chloride and chloroxylenol, were not covered by the rule. FDA’s 2017 guidance describes their review as deferred for one year, subject to renewal, pending ongoing studies, and its consumer update says they may still be used. That is the status as stated in those documents; check FDA for anything newer. For background on the first of these, see what benzalkonium chloride is.
How the evidence standard works
FDA did not ask whether an ingredient kills germs in a laboratory test. It looked for a direct clinical benefit, meaning a reduction of infection, greater than that of non-antibacterial soap and water. It found the data insufficient, and cited three safety concerns: systemic exposure higher than previously thought, long-term exposure, and a possible effect on bacterial resistance. An FDA official is quoted in the consumer update: “There’s no data demonstrating that these drugs provide additional protection from diseases and infections.” FDA says these products may give people a false sense of security.
Hand sanitizers fall outside this rule; for that separate product category, see how to use hand sanitizer and hand sanitizer ingredients.
Scope of the rule at a glance
| Product or ingredient group | Status in FDA’s consumer antiseptic wash rule |
|---|---|
| Consumer hand washes, body washes and bar soaps containing any of the 19 named ingredients (including triclosan and triclocarban) | Misbranded and considered new drugs; need an approved application to be marketed |
| Benzalkonium chloride, benzethonium chloride, chloroxylenol | Not covered by the rule; review deferred per the 2017 guidance, with studies ongoing |
| Hand sanitizers and hand wipes | Excluded from the rule |
| Antibacterial soaps used in health-care settings such as hospitals and nursing homes | Excluded from the rule |
| Chlorhexidine gluconate, ethyl alcohol, isopropyl alcohol, cetylpyridinium chloride, polyhexamethylene biguanide, sodium hypochlorite, salicylic acid, tea tree oil and others in the guidance’s list | Not eligible for review under the over-the-counter process as consumer washes; they would need a new drug application |
The last row matters for supply staff: products such as chlorhexidine skin cleansers sit in a different regulatory category from the consumer washes the rule addressed. See how to use chlorhexidine and what an antiseptic is.
Where it matters for labs, clinics and supply decisions
A label check built only from FDA’s own descriptions can separate three product types that are easy to confuse:
- Consumer wash. Rinse-off product with “antibacterial” wording, possibly a Drug Facts label. If it lists triclosan, triclocarban or another of the 19 ingredients, it falls under the 2016 rule.
- Remaining ingredients to recognise. Benzalkonium chloride, benzethonium chloride or chloroxylenol on the label identifies a product whose ingredient was deferred rather than removed.
- Sanitizer, wipe or health-care antiseptic. These categories were outside the scope of the 2016 rule.
Related topics for clinical settings are skin antisepsis, covered in skin antisepsis before injection, and how hand hygiene is audited, in the hand hygiene audit tool guide.
Common misunderstandings
“Antimicrobial” does not mean proven better
FDA found no demonstrated additional protection from the removed ingredients compared with plain soap and water.
The rule did not cover every germ-killing product
Sanitizers, wipes and health-care antibacterial soaps were excluded, so the rule should not be read as a ban on all antimicrobial products.
Not every antiseptic is on the removed list
Chlorhexidine gluconate and alcohols appear in the guidance as ineligible for OTC review as consumer washes, which is a separate point from the 19 removed ingredients.
Frequently asked questions
What is antimicrobial soap?
It is a soap or wash with an added antimicrobial active ingredient, marketed as killing or reducing germs. FDA’s guidance calls the consumer versions “antibacterial soaps, antibacterial hand washes, and antibacterial body washes.”
Which antimicrobial soap ingredients were removed?
Nineteen, including triclosan and triclocarban, listed in full above. Products containing them are misbranded and are considered new drugs under the rule, which took effect on 6 September 2017.
Are benzalkonium chloride, benzethonium chloride and chloroxylenol banned?
No. The rule does not apply to them, and FDA’s consumer update says they may be used in currently marketed consumer washes while studies continue. Check FDA for anything newer than the sources below.
Is antimicrobial soap the same as hand sanitizer?
No. Hand sanitizers and hand wipes are not rinsed off and were excluded from the rule, as were antibacterial soaps used in health-care settings.
Does antibacterial soap work better than plain soap?
FDA found the data insufficient to show that the removed ingredients reduce infection more than non-antibacterial soap and water.
Sources
- US FDA, “Skip the Antibacterial Soap; Use Plain Soap and Water” consumer update, https://www.fda.gov/consumers/consumer-updates/skip-antibacterial-soap-use-plain-soap-and-water (content current as of 12/12/2024; checked 30 October 2026).
- US FDA, “Consumer Antiseptic Wash Final Rule Questions and Answers,” guidance, July 2017, https://www.fda.gov/media/106652/download (checked 30 October 2026).
