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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2014]
[CITE: 21CFR355]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 355ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

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]

Sec. 355.20 Packaging conditions.

(a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the following package size limitations are required for anticaries drug products:

(1) Dentifrices. Dentifrice (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per package.

(2) Preventive treatment gels and treatment rinses. Preventive treatment gel and treatment rinse packages shall not contain more than 120 mg total fluorine per package.

(3) Exception. Package size limitations do not apply to anticaries drug products marketed for professional office use only and labeled in accord with 355.60.

(b) Tight container packaging. To minimize moisture contamination, all fluoride powdered dentifrices shall be packaged in a tight container as defined as a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 60 FR 52507, Oct. 6, 1995, unless otherwise noted.

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