Getting started

From formula to bottle

Updated October 2026

On this page8

One: is it a drug or a cosmetic?Two: compute the ethanol per package Three: compute the fluoride two ways Four: decide the dispenser, knowing one exemption depends on it Then the ordinary packaging decisions Oil pulling is the simplest case Keep the two calculations per size References

You cannot finish either calculation without the fill volume, which puts the container early.

One: is it a drug or a cosmetic?

A fluoride anticaries product is an over-the-counter drug under the monograph. A tooth powder with no fluoride, an oil pulling blend and most whitening gels sold on appearance are cosmetics. That decision sets the label.

Two: compute the ethanol per package

Grams of ethanol in the container, against 3 g. Concentration times fill volume times density, so a 500 mL mouthwash at a modest alcohol level clears 3 g comfortably and a 50 mL travel size may not.

Three: compute the fluoride two ways

Elemental fluoride in milligrams per package against 50 mg, and elemental fluoride as a percentage against 0.5 percent. Both have to be over before the requirement applies, and the element is what counts rather than the salt.

Four: decide the dispenser, knowing one exemption depends on it

If you intend to rely on the mouthwash pump exemption, the pump must be nonremovable and must meter at or below 0.03 grams of absolute ethanol per actuation. That is a question for a pump manufacturer, not a catalog.

Then the ordinary packaging decisions

Material against the formula, a neck with the fitment you want, a liner that seals, and a label that fits either the Drug Facts panel or a cosmetic ingredient declaration depending on step one.

Oil pulling is the simplest case

No ethanol, no fluoride, no monograph. It is a cosmetic in a bottle, and the only real questions are material compatibility with the oil and whether the format suits a product used by the mouthful.

Keep the two calculations per size

Ethanol grams and fluoride milligrams and percentage, for every fill volume, dated. Adding a size reopens both, and nothing in a normal product process forces that.

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 355.10, Anticaries active ingredients, which sets each permitted active by concentration and dosage form: a gel or paste dentifrice at 850 to 1,150 ppm theoretical total fluorine, sodium fluoride 0.188 to 0.254 percent with available fluoride ion at or above 650 ppm, and separate entries for treatment rinses. 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.