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Updated October 2026

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What this covers The ethanol entry Which makes the pump the compliance route The fluoride entry So the fill size matters again And fluoride toothpaste is a drug One thing we cannot supply Three rules, one category, and they interact References

One of these rules tells you how much ethanol the pump may deliver per stroke, which is unlike anything else in this library.

What this covers

Mouthwash, breath spray, toothpaste, tooth powder, whitening gel and oil pulling. Six leaves across three distinct archetypes, which means somebody researched this group rather than stamping one default across it.

The ethanol entry

A mouthwash containing 3 g or more of ethanol in a single package needs child-resistant packaging. The paragraph then exempts products with a nonremovable pump dispenser meeting three further conditions, one of which is a dose per actuation.

Which makes the pump the compliance route

The pump has to be nonremovable, the formula has to carry at least 7 percent mint or cinnamon flavoring oils by weight, each actuation may deliver no more than three hundredths of a gram of absolute alcohol, and the unit has to hold under 15 grams. Three of the four are hardware.

The fluoride entry

More than 50 milligrams of elemental fluoride per package, and more than 0.5 percent elemental fluoride by weight for a non-liquid or by volume for a liquid. Two tests, both required, and the first is per package.

So the fill size matters again

Same shape as the iron rule for capsules and the acetonitrile rule for nail glue remover. A mass-per-package trigger means the bottle size is part of the calculation rather than a separate decision.

And fluoride toothpaste is a drug

An anticaries product is an over-the-counter drug with a monograph: permitted actives at set concentrations, an identity statement built from menus, a prescribed Indication and a verbatim warning about children under six.

One thing we cannot supply

A nonremovable pump. Every pump in this catalog is a removable screw-on fitment, so the mouthwash exemption cannot be assembled from this shelf. The containers section gives the measured position.

Three rules, one category, and they interact

The ethanol paragraph, the fluoride paragraph and the anticaries monograph can all reach the same product line at once, and the fluoride rinse sits inside the mouthwash definition as well. Working out which apply is the first task rather than a late check.

References

16 CFR 1700.14(a)(22), Mouthwash. Preparations containing 3 g or more of ethanol in a single package require special packaging, except products with nonremovable pump dispensers containing at least 7 percent weight-to-weight mint or cinnamon flavoring oils, dispensing no more than 0.03 grams of absolute ethanol per actuation, and containing less than 15 grams of ethanol in a single unit. The paragraph defines mouthwash to include mouthrinses, oral antiseptics, gargles, fluoride rinses, anti-plaque rinses and breath fresheners, and to exclude throat sprays and aerosol breath fresheners. law.cornell.edu

16 CFR 1700.14(a)(27), Fluoride. Household substances containing more than the equivalent of 50 milligrams of elemental fluoride per package and more than the equivalent of 0.5 percent elemental fluoride weight-to-volume for liquids or weight-to-weight for non-liquids require special packaging. law.cornell.edu

21 CFR 355.50, Labeling of anticaries drug products. Paragraph (a) assembles the identity statement from fixed menus and allows "mouthwash" in place of "rinse" only where the product also has a cosmetic use; (b) gives the Indication wording; (c)(1) sets the verbatim warning for all fluoride dentifrice products, replacing the general warning statements in 21 CFR 330.1(g). law.cornell.edu

Written from federal regulation and from measured catalog data, not from a formulation bench. Whether a product crosses the ethanol or fluoride thresholds is a calculation about your formula and your fill, and whether a pump satisfies the exemption is a question for the pump manufacturer. Nothing here certifies a package.