Cosmetic or drug

The words you may use

Updated October 2026

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The identity statement The Uses phrase One optional addition about stress Duration claims need 20 percent "Extra effective" needs 30 percent With one stay worth knowing about Other truthful statements are allowed, narrowly References

The Uses statement is a fill-in-the-blank with a closed menu.

The identity statement

The labeling contains the established name of the drug, if any, and identifies the product as an "antiperspirant". So the word itself has to appear; calling it a deodorant and nothing else does not satisfy the paragraph.

The Uses phrase

Under the heading "Uses", the labeling states one of "decreases", "lessens" or "reduces", then "underarm", then one of "dampness", "perspiration", "sweat", "sweating" or "wetness". Three choices by five, and that is the required statement.

One optional addition about stress

The labeling may state that it also decreases, lessens or reduces underarm dampness, perspiration, sweat, sweating or wetness due to stress. Same menu, same structure.

Duration claims need 20 percent

For products that demonstrate standard effectiveness, which the paragraph defines as 20 percent sweat reduction, over a 24-hour period, the labeling may state "all day protection", "lasts all day", "lasts 24 hours" or "24 hour protection".

"Extra effective" needs 30 percent

For products that demonstrate extra effectiveness, defined as 30 percent sweat reduction. And a product demonstrating extra effectiveness sustained over 24 hours may make both sets of claims.

With one stay worth knowing about

At 69 FR 61149, 15 October 2004, the limitation of the enhanced duration claim to 24 hours in paragraphs (b)(3) and (b)(5) was stayed until further notice. A regulation with a stay on it is exactly the kind of thing to check currently rather than assume.

Other truthful statements are allowed, narrowly

Other truthful and nonmisleading statements describing only the established uses may be used, subject to the misbranding provisions and the prohibition on unapproved new drugs. That is a narrow permission, not an open one.

References

21 CFR 350.50, Labeling of antiperspirant drug products. Paragraph (a) requires the product to be identified as an antiperspirant; (b)(1) gives the Uses statement as a choice of one of three verbs and one of five nouns; (b)(3) and (b)(4) tie duration and "extra effective" claims to 20 percent and 30 percent sweat reduction; (c) sets four verbatim warnings; (d) sets the direction "apply to underarms only". law.cornell.edu

21 CFR 350.10, Antiperspirant active ingredients, a closed list with maximum concentrations calculated on an anhydrous basis excluding buffer components: aluminum chloride up to 15 percent in an aqueous nonaerosol solution, the chlorohydrates and chlorohydrex glycols up to 25 percent, and the aluminum zirconium compounds up to 20 percent, with USP-NF atomic ratios where applicable. law.cornell.edu

Written from the federal monograph, not from a formulation bench. Whether a given product is a cosmetic or a drug turns on its ingredients and its claims, and that is a determination with consequences; nothing here substitutes for getting it right for a specific formula and label.