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The four formats

The spray, and the aerosol question

Updated

On this page8
The widest shelf of the four, and the format where the label gets longer.

The shelf

Four hundred and sixty-three containers from under 2 mL to 946 mL, with 239 closures. By material 373 PET and 90 glass. By form 184 Boston rounds, 90 packers, 66 cosmo and bullet, 44 cylinder rounds.

The necks

24-410 at 149 containers, 20-410 at 70, 38-400 at 67, 28-410 at 34 and 45-400 at 33. The fine mist sprayers this format needs sit on the narrower finishes, and 24-410 is the obvious place to standardize.

Pump, not aerosol

Everything on this shelf is a pump format. Nothing here is a pressurized can, so if your product is an aerosol antiperspirant this is not the shelf and the filling is a different operation entirely.

Which also simplifies the label

The two extra warnings in the monograph attach to an aerosolized dosage form: the keep-away-from-face statement and the pressurized dispenser warning under 21 CFR 369.21. A pump spray carries neither.

And the active list treats the forms differently

Some permitted actives are specified in an aerosol or nonaerosol dosage form and others only in a nonaerosol form, with aluminum chloride limited to an aqueous solution nonaerosol form at up to 15 percent. Format and active are one decision.

Light protection is available

136 clear, 116 amber, 65 blue, 60 white and 30 green. For an essential oil based deodorant spray the amber and blue options matter, because the fragrance materials are the light-sensitive part.

Glass for aggressive formulas

Ninety glass containers out of 463. A high-alcohol or essential-oil-heavy spray attacks plastics and adhesives, and glass removes the bottle from that argument, leaving the sprayer and the label to test.

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 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
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.