CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR355.20]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 355 -- ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B - Active Ingredients

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.