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All Containers›Shop by use case›Dish and hand›Claims›Antiseptic washes are drugs, and ingredients have been removedShop all dish and hand →
Claims

Antiseptic washes are drugs, and ingredients have been removed

Updated

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This is not a theoretical regime. Ingredients that were ordinary in consumer antibacterial soap were taken out of it, by name.

What the regulation did

Section 310.545 lists active ingredients not generally recognized as safe and effective for consumer antiseptic hand wash and body wash products. Triclosan and triclocarban are among those named, approved as of September 6, 2017, which removed them from the over-the-counter route for that use.

Which is a useful thing to understand about the category

Antibacterial soap was a mass-market product built on ingredients that were later found not to have demonstrated they were better than plain soap for that purpose. The claim had been made for decades before the evidence was examined.

And it is why plain soap is the honest product

Washing with ordinary soap and water works, and it carries no drug regime, no monograph question and no ingredient that might be withdrawn. For a small maker that is a genuinely better place to be than chasing an antibacterial claim.

Hand sanitizer is a separate case again

Alcohol rubs are handled under their own arrangements rather than by the section above, and they remain over-the-counter drug products with a Drug Facts panel and a stated active ingredient concentration. Adding one to a soap range is entering the drug regime.

Which brings manufacturing expectations with it

A drug product carries facility and record requirements well beyond what a cosmetic maker is used to. That is usually a bigger practical barrier than the label, and it is the reason most small ranges stop at plain soap.

Do not inherit a claim from a supplier

A base or a surfactant blend sold with marketing language about antibacterial properties does not license you to repeat it. The claim belongs to whoever puts it on a label, which is you.

The honest comparison is with plain soap and water

Which is the comparison the regulation turned on. A maker selling plain soap is not offering a lesser product, and saying so plainly is both accurate and a better position than competing on a claim you would have to defend.

References

21 CFR 310.545, which covers consumer antiseptic hand wash and body wash drug products as over-the-counter drugs and names active ingredients not generally recognized as safe and effective for that use, including triclosan and triclocarban, as of September 6, 2017. law.cornell.edu
Written from federal regulation, not from a formulation bench. An antiseptic wash is an OTC drug and a surface disinfectant is a pesticide, and a plain soap is neither until it makes a claim. Nothing here clears a specific label.