Five questions, and three of them have to be answered per fill size.
One: drug or cosmetic?
A fluoride anticaries product is an over-the-counter drug under 21 CFR part 355, with permitted actives at set concentrations and dosage forms. A fluoride-free powder, an oil pulling blend or a whitening gel sold on appearance is a cosmetic.
Two: ethanol grams per package
Against 3 g. Concentration times fill volume times density. Ethanol is about 0.789 g per milliliter, so 3 g is under 4 milliliters of pure alcohol and most alcoholic rinses clear it easily.
Three: fluoride, both ways
Milligrams of elemental fluoride per package against 50 mg, and elemental fluoride percentage against 0.5 percent weight-to-weight or weight-to-volume. Both have to be over. Convert from the salt to the element, and state the basis.
Four: if you are relying on the pump exemption, can you meet all four conditions?
All four: the dispenser nonremovable, the flavoring oils at 7 percent or above by weight, the metered dose within the stated limit per stroke, and the unit under 15 grams of ethanol. Our catalog cannot supply the first of those.
Five: is the label the right kind, with the right words?
For a drug: the identity statement from the menus, the Indication wording, the verbatim warning with the bold part bold and the age correct for the dosage form, in the Drug Facts panel, replacing the general warning statements.
Flavor oils and ethanol together are harder on a gasket, dip tube and liner than either alone. Ask with both numbers named and keep a weighed control sample.
File it per size
Classification, ethanol grams, fluoride milligrams and percentage, the dispenser decision and the label version, one row per fill volume. Adding a size reopens three of the five.
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.edu16 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.edu16 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.edu21 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.edu21 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 