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From recipe to product

Updated October 2026

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One: establish cosmetic or drug Two: if it is a drug, check the active against the list Three: decide what effectiveness you can prove Four: choose the format with the shelf in mind Five: write the label from the regulation Do not mix the two vocabularies Keep the five answers with the formula The order is not negotiable here References

One decision governs the rest: are you reducing sweat or addressing odor.

One: establish cosmetic or drug

Does the product reduce the production of perspiration, and will you say so? If yes to either, you are in the antiperspirant monograph. If it addresses odor and you only claim that, it is a cosmetic.

Two: if it is a drug, check the active against the list

The permitted actives and their maximum concentrations are enumerated, calculated on an anhydrous basis excluding buffer components, and some must meet USP-NF atomic ratios. An active outside that list is not a monograph product.

Three: decide what effectiveness you can prove

The duration and "extra effective" claims rest on 20 percent and 30 percent sweat reduction. If you have no testing, those words are not available, and planning the label around them before testing is the common sequence error.

Four: choose the format with the shelf in mind

Cream has 253 containers behind it, spray 463, powder 54. The stick has 13 jars and three tubes elsewhere in the catalog. That is a real input to the decision rather than an afterthought.

Five: write the label from the regulation

For a drug: the antiperspirant identity, the Uses phrase from the menu, the four warnings verbatim, the direction, and the Drug Facts format. For a cosmetic: ordinary cosmetic labeling and nothing from the monograph.

Do not mix the two vocabularies

A cosmetic deodorant carrying a Drug Facts panel, or an antiperspirant describing itself only as a deodorant, are both wrong in ways that are easy to produce by borrowing a competitor’s artwork.

Keep the five answers with the formula

Classification, active and concentration, test data, format and label version. A reformulation can move the classification itself, which puts every other answer back in play at once.

The order is not negotiable here

Classification first, because it determines whether there is a Drug Facts panel to lay out, and that determines which containers are even usable. Choosing the jar first and classifying afterwards is how a finished artwork becomes unprintable.

References

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

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.