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Ethanol, and 3 grams per package

Updated October 2026

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The requirement Which a normal bottle clears easily The definition is broader than the word And it has explicit exclusions So a breath spray needs classifying carefully A smaller bottle is a genuine lever Alcohol-free removes the question Compute it, do not estimate from the percentage References

Three grams is not very much ethanol, and the paragraph defines mouthwash broadly.

The requirement

Mouthwash preparations for human use containing 3 g or more of ethanol in a single package shall be packaged in accordance with 1700.15(a), (b) and (c). A mass, in a package, with no concentration test alongside it.

Which a normal bottle clears easily

Ethanol is about 0.789 g per milliliter, so 3 grams is under 4 milliliters of pure alcohol. A 500 mL mouthwash at even a low alcohol level is far past it, which is why the exemption matters so much in this category.

The definition is broader than the word

The term mouthwash includes liquid products variously called mouthwashes, mouthrinses, oral antiseptics, gargles, fluoride rinses, anti-plaque rinses and breath fresheners. So a fluoride rinse is a mouthwash for this paragraph.

And it has explicit exclusions

It does not include throat sprays or aerosol breath fresheners. That is a real distinction for the breath spray leaf in this group: the format decides whether the paragraph reaches it.

So a breath spray needs classifying carefully

A pump breath freshener is inside the definition; a throat spray is named as outside it. The difference is what the product is, and the paragraph does not leave that to inference.

A smaller bottle is a genuine lever

Because the trigger is a mass per package rather than a concentration. A travel size can sit under 3 g while the full size does not, which again means one range with two answers in it.

Alcohol-free removes the question

Many mouthwashes are now formulated without ethanol, which takes this paragraph out entirely. That is a formulation route rather than a packaging one and it is worth naming as an option.

Compute it, do not estimate from the percentage

A label percentage is by volume and the threshold is a mass, so the density has to come into it. Three grams sounds small and it is, which is precisely why the arithmetic is worth doing properly once.

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 1700.15, Poison prevention packaging standards: not less than 85 percent child-resistant effectiveness without a demonstration and 80 percent after one, with the packaging required to keep working in actual contact with the substance and across the openings and closings customary for its size and contents, and not to be reused. 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.