Tools and directories

The check, before the formula is locked

Updated October 2026

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One: cosmetic or drug?Two: if a drug, is the active on the list and under its ceiling?Three: which claims can you actually prove?Four: is every required statement present and verbatim?Five: will it fit on the container you want?And for the stick, test the mechanism File the five answers with the formula Most of this is decided in words, not chemistry References

Five questions, and the first one decides how much work the other four are.

One: cosmetic or drug?

Does the product reduce the production of perspiration, and will anything you publish say so? Either one puts you in the antiperspirant monograph. Addressing odor, and claiming only that, keeps it a cosmetic.

Two: if a drug, is the active on the list and under its ceiling?

Checked on an anhydrous basis, excluding buffer components, against the enumerated maximum for that compound and that dosage form, and meeting the USP-NF atomic ratios where they apply. Get the raw material specification from the supplier.

Three: which claims can you actually prove?

The base Uses phrase needs no testing. "Lasts 24 hours" and the other duration claims need 20 percent sweat reduction demonstrated over 24 hours; "extra effective" needs 30 percent. Decide this before artwork.

Four: is every required statement present and verbatim?

The antiperspirant identity, the Uses phrase from the menu, the three standard warnings including the kidney disease one, the two extra aerosol warnings if applicable, and "apply to underarms only", all in the Drug Facts format.

Five: will it fit on the container you want?

A Drug Facts panel on a 59 mL jar or a 65 mL tube is tight. Work the label out against the actual container before committing to tooling, artwork or a case quantity.

And for the stick, test the mechanism

Filled with your real base, in the real tube, twisted repeatedly, left hot and left cold over weeks. Binding and slumping are mechanical failures that only appear in use.

File the five answers with the formula

Classification, active and calculated percentage, test data, label version and container. A reformulation can move the classification itself, and then all five need rechecking rather than one.

Most of this is decided in words, not chemistry

Four of the five questions are about classification, claims and label text, and only one is about the formula. That is the shape of this category, and it is why the expensive mistakes here are made by marketing rather than by the bench.

References

21 CFR 350.3, the definition: "Antiperspirant. A drug product applied topically that reduces the production of perspiration (sweat) at that site." 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

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 201.66, the Drug Facts format for over-the-counter drug labeling, which 21 CFR 350.50 cross-references for the definition of a bullet and which sets the panel an antiperspirant label has to carry. law.cornell.edu

21 CFR 369.21, the warning required for drugs in dispensers pressurized by gaseous propellants, cross-referenced by 21 CFR 350.50(c)(4)(ii) for aerosol antiperspirants. 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.