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Cosmetic or drug

The actives, and the ceilings

Updated

On this page8
The monograph does not describe a kind of ingredient. It names them, with ceilings.

How the section is built

The active ingredient of the product consists of any of the listed items, within the established concentration and dosage formulation. So it is a list of named compounds, each with a maximum, and the dosage form matters for some of them.

The ceilings

Aluminum chloride up to 15 percent, calculated on the hexahydrate form, in an aqueous solution nonaerosol dosage form. The aluminum chlorohydrates and chlorohydrex glycols up to 25 percent. The aluminum zirconium compounds up to 20 percent.

Anhydrous basis, excluding buffers

The concentrations are calculated on an anhydrous basis, omitting any buffer component present in the compound. That is an arithmetic instruction and it changes the number you compare against the ceiling.

And the declared percentage excludes more again

The labeled declaration of the percentage of the active ingredient should exclude any water, buffer components or propellant. So the figure on the label is not the figure on your batch sheet unless you did that calculation.

Atomic ratios, where applicable

Where applicable the ingredient must meet the aluminum to chloride, aluminum to zirconium, and aluminum plus zirconium to chloride atomic ratios described in the USP-NF. That is a specification on the raw material, from your supplier.

Aerosol and nonaerosol are treated separately

Some paragraphs apply in an aerosol or nonaerosol dosage form and others only in a nonaerosol form. So the format decision and the active decision are connected rather than independent.

Outside the list is outside the monograph

A novel active, or a listed one above its ceiling, is not a monograph product. That is a much larger undertaking than a label change, and it is the right thing to establish before a formula is settled.

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