[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR355.10]

[Page 302]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 355_ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of 
 
                      Subpart B_Active Ingredients
 
Sec.  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 [gteqt] 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 [gteqt] 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 [gteqt] 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]