Two entries

Fluoride, two tests

Updated October 2026

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The requirement Elemental fluoride, not sodium fluoride Which means a normal toothpaste fails the second test Both tests, every time The mass test still depends on the package And it is not limited to oral care Record both figures with their basis This is the paragraph where the second test saves you References

Two tests again, and the element is what counts, not the salt.

The requirement

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, need special packaging.

Elemental fluoride, not sodium fluoride

Sodium fluoride is about 45 percent fluoride by mass, so a 0.24 percent sodium fluoride dentifrice carries roughly 0.11 percent elemental fluoride. Converting correctly is the difference between a right and a wrong answer here.

Which means a normal toothpaste fails the second test

At around 0.1 percent elemental fluoride a standard dentifrice is well under the 0.5 percent figure, so the paragraph does not reach it even though a large tube passes the 50 mg mass test comfortably.

Both tests, every time

That is the whole point of running the arithmetic rather than assuming. A high-concentration professional product is a different case from a retail dentifrice, and only the calculation distinguishes them.

The mass test still depends on the package

Fifty milligrams of elemental fluoride is not much, so any realistic fluoride product clears it. The concentration test is the one doing the work, which is the opposite of the ethanol paragraph.

And it is not limited to oral care

The paragraph says household substances, so it reaches anything containing fluoride at those levels. Oral care is simply where such products mostly are.

Record both figures with their basis

Milligrams of elemental fluoride per package, and the percentage with weight-to-weight or weight-to-volume stated. A figure without its basis cannot be rechecked and will be recomputed wrongly later.

This is the paragraph where the second test saves you

An ordinary dentifrice passes the mass test and fails the concentration test, so it is outside the requirement. That is the opposite of the ethanol paragraph, where the mass test catches almost everything, and the contrast is the useful thing to carry away.

References

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

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.