[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR355.20]

[Page 286]
 
                        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 Contents
 
                      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 Sec. 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.