What goes wrong

The exemption was not available

Updated October 2026

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How it happens What a removable pump leaves And the other three conditions still apply The dose per actuation needs the pump maker Our catalog cannot supply the first condition So the honest routes are two Alcohol-free is the common answer now Read the condition before buying the pump References

The mouthwash exemption is conjunctive, and a removable pump fails it at the first condition.

How it happens

A maker reads that a pump dispenser exempts a mouthwash, buys a lotion pump, and believes the question is settled. The word in the regulation is nonremovable, and a screw-on pump is removable by design.

What a removable pump leaves

The neck underneath it. The exemption contemplates a dispenser a user cannot take off to reach the liquid, which is the same reasoning as the spray-device exemption in the diffuser rules.

And the other three conditions still apply

At least 7 percent mint or cinnamon flavoring oils by weight, no more than 0.03 grams of absolute ethanol per actuation, and under 15 grams of ethanol in the unit. A nonremovable pump alone is not enough either.

The dose per actuation needs the pump maker

It is a metering performance figure combined with your alcohol concentration. Nobody can answer it from a catalog listing, and it is the condition most likely to be assumed rather than established.

Our catalog cannot supply the first condition

Measured across all 2,150 products, nothing matches non-removable, nonremovable, crimp or locking. All 39 lotion pumps, 14 treatment pumps, 9 airless pumps and 6 foamer pumps are removable screw-on fitments.

So the honest routes are two

Formulate without ethanol, or below 3 g per package, and the paragraph does not apply. Or use tested child-resistant packaging. The exemption is a third route that needs a component we do not stock.

Alcohol-free is the common answer now

Much of the category has moved that way, and it removes a packaging constraint as well as a compliance one. That is worth weighing before engineering around the exemption.

Read the condition before buying the pump

One word, nonremovable, decides whether a pump is a compliance route or an ordinary fitment. It is cheaper to read than to discover after a case quantity of pumps has arrived.

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.