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All Containers›Shop by use case›Oral care›Cosmetic or drug›The required warningShop all oral care →
Cosmetic or drug

The required warning

By Dwight Davis, Founder

Updated

On this page8
Printed in the regulation and reproduced, with the bold part specified.

For all fluoride dentifrice products

Gel, paste and powder. Under the heading "Warning": "Keep out of reach of children under 6 years of age." highlighted in bold type, then "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."

The bold is part of the requirement

The regulation specifies that the first sentence is highlighted in bold type. That is a typographic instruction inside a labeling rule, and it is the kind of detail a designer will quietly normalize away.

Under 6, specifically

Not children generally. The dentifrice warning names an age, which is narrower than the usual keep-out-of-reach language and is easy to get wrong by borrowing another product’s wording.

Rinses and treatment gels differ

For fluoride rinse and preventive treatment gel products the warning is "Keep out of reach of children." in bold, then the same accidental swallowing sentence with brushing or rinsing selected as appropriate. No age in that one.

These replace the general warnings

The regulation says they shall be used in place of the general warning statements required by 21 CFR 330.1(g). So carrying both is not belt and braces, it is the wrong label.

And they sit inside Drug Facts

An over-the-counter drug carries the Drug Facts panel with its headings, order and typography. On a small tube or a travel bottle that is a real layout constraint and it has to be designed for rather than squeezed in.

Which is another argument for classifying first

A cosmetic tooth powder needs an ingredient declaration and no panel. Discovering the drug classification after artwork is approved means rebuilding the label around a structure nobody allowed space for.

References

21 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
21 CFR 701.3, the cosmetic ingredient declaration, which requires ingredients in descending order of predominance on the label of a cosmetic in package form. 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.