Buy a full case and the price per unit drops automaticallyRequest a sample
AccountCart0
All ContainersBottlesJarsCaps & ClosuresPumps & SprayersTubs & PailsJugsDroppersTinsTubesAccessories
Industries
Learn
Getting started

Is this for you at all

Updated

On this page8
If the product reduces sweat rather than odor, it is a drug, and the monograph decides almost everything about the label.

What this covers

Deodorant sticks, deodorant creams, deodorant sprays and body powders. Four formats, and unusually for this library the taxonomy gives each one its own process signature rather than a blanket default, which is a sign somebody actually looked.

The definition that divides them

An antiperspirant is a drug product applied topically that reduces the production of perspiration at that site. A deodorant addresses odor. One sentence, and it decides whether you are selling a cosmetic or an over-the-counter drug.

What the drug side brings

A closed list of permitted active ingredients with maximum concentrations, an obligation to identify the product as an antiperspirant, a Uses statement assembled from a fixed menu of words, four verbatim warnings and one prescribed direction.

And two claims that need a number

"Lasts 24 hours" or "all day protection" is available only for products demonstrating standard effectiveness, which the regulation defines as 20 percent sweat reduction. "Extra effective" needs 30 percent. Those are measurements, not adjectives.

The cosmetic side is not unregulated

A deodorant is a cosmetic, with cosmetic labeling and safety obligations. What it does not carry is the monograph: no active ingredient list, no Drug Facts panel and no effectiveness claims about sweat.

Most natural deodorant is the cosmetic

Which is the commercially important point. A baking soda or magnesium cream that controls odor is a cosmetic, and the whole of the drug apparatus only arrives if somebody starts claiming it stops sweat.

One format we cannot fully supply

The twist-up stick. The archetype for it promises a tube and the derived shelf holds 13 jars and no tubes at all. The catalog does have three deodorant containers, and the containers section says exactly which.

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 350.50, 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.