Editorial Note on Part 355
Editorial Note: Nomenclature changes to part 355 appear at 69 FR 13717, Mar. 24, 2004.

§ 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when used in the concentration and dosage form established for each ingredient: ( a ) *Sodium fluoride* — ( 1 ) *Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.* Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration ≥650 parts per million (ppm).
( 2 ) *Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a powdered dosage form.* Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration of ≥850 ppm for products containing the abrasive sodium bicarbonate and a poured-bulk density of 1.0 to 1.2 grams per milliliter.
( 3 ) *Treatment rinses.* ( i ) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, monobasic, and phosphoric acid to a level of 0.1 molar phosphate ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion concentration of 0.02 percent.
( ii ) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, dibasic, and phosphoric acid to a pH of 3.5 and which yields an effective fluoride ion concentration of 0.01 percent.
( iii ) Sodium fluoride 0.02 percent aqueous solution with a pH of approximately 7.
( iv ) Sodium fluoride 0.05 percent aqueous solution with a pH of approximately 7.
( v ) Sodium fluoride concentrate containing adequate directions for mixing with water before using to result in a 0.02-percent or 0.05-percent aqueous solution with a pH of approximately 7.
( b ) *Sodium monofluorophosphate* — ( 1 ) *Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.* Sodium monofluorophosphate 0.654 to 0.884 percent with an available fluoride ion concentration (consisting of PO3 F= and F− combined) ≥800 ppm.
( 2 ) *Dentifrices containing 1,500 ppm theoretical total fluorine in a gel or paste dosage form.* Sodium monofluorophosphate 1.153 percent with an available fluoride ion concentration (consisting of PO3 F= and F− combined) ≥1,275 ppm.
( c ) *Stannous fluoride* — ( 1 ) *Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.* ( i ) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration ≥700 ppm for products containing abrasives other than calcium pyrophosphate.
( ii ) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration ≥290 ppm for products containing the abrasive calcium pyrophosphate.
( 2 ) *Preventive treatment gel.* Stannous fluoride 0.4 percent in an anhydrous glycerin gel, made from anhydrous glycerin and the addition of suitable thickening agents to adjust viscosity.
( 3 ) *Treatment rinse.* Stannous fluoride concentrate marketed in a stable form and containing adequate directions for mixing with water immediately before using to result in a 0.1-percent aqueous solution.
[60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996]