The anticaries monograph

The actives, by 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 an available fluoride ion concentration at or above 650 ppm. A powdered dentifrice at the same range needs available fluoride at or above 850 ppm with sodium bicarbonate abrasive and a poured-bulk density of 1.0 to 1.2 g/mL.

Which is unusually specific

The monograph names the abrasive and a bulk density for the powder entry. So a tooth powder is not simply a toothpaste without water, and the dosage form carries its own conditions.

Treatment rinses have their own entries

Including acidulated phosphate fluoride solutions at a stated phosphate molarity and pH range yielding a specified effective fluoride ion concentration, and plain sodium fluoride solutions at 0.02 and 0.05 percent at approximately neutral pH.

The identity statement is assembled from menus

Anticavity or fluoride, then one of dentifrice, toothpaste, tooth polish, tooth powder, preventive treatment gel, rinse, concentrated solution, rinse powder or rinse effervescent tablets. Not a phrase you write.

And "mouthwash" is conditionally permitted

The word mouthwash may be substituted for rinse in the identity statement only if the product also has a cosmetic use as defined in the Act. So the familiar word is available only where the product genuinely does both jobs.

The Indication is prescribed too

"Aids in the prevention of dental" followed by one of cavities, decay, caries (decay) or caries (cavities). Other truthful statements describing only the established indication are allowed, narrowly.

A product with no fluoride is a cosmetic

A tooth powder, an oil pulling blend or a whitening gel sold on appearance sits outside the monograph, with cosmetic ingredient labeling instead. That is a simpler label and often the accurate classification.

References