[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR355.3]

[Page 301-302]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 355_ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 355.3  Definitions.

    As used in this part:
    (a) Abrasive. Solid materials that are added to dentifrices to 
facilitate mechanical removal of dental plaque, debris, and stain from 
tooth surfaces.
    (b) Anhydrous glycerin. An ingredient that may be prepared by 
heating glycerin U.S.P. at 150 -C for 2 hours to drive off the moisture 
content.
    (c) Anticaries drug. A drug that aids in the prevention and 
prophylactic treatment of dental cavities (decay, caries).
    (d) Dental caries. A disease of calcified tissues of teeth 
characterized by demineralization of the inorganic portion and 
destruction of the organic matrix.
    (e) Dentifrice. An abrasive-containing dosage form (gel, paste, or 
powder) for delivering an anticaries drug to the teeth.
    (f) Fluoride. The inorganic form of the chemical element fluorine in 
combination with other elements.
    (g) Fluoride ion. The negatively charged atom of the chemical 
element fluorine.
    (h) Fluoride supplement. A special treatment rinse dosage form that 
is intended to be swallowed, and is promoted to health professionals for 
use in areas where the water supply contains 0 to 0.7 parts per million 
(ppm) fluoride ion.
    (i) Preventive treatment gel. A dosage form for delivering an 
anticaries drug to the teeth. Preventive treatment gels are formulated 
in an anhydrous glycerin base with suitable thickening agents included 
to adjust viscosity. Preventive treatment gels do not contain abrasives.
    (j) Treatment rinse. A liquid dosage form for delivering an 
anticaries drug to the teeth.
    (k) Treatment rinse concentrated solution. A fluoride treatment 
rinse in a concentrated form to be mixed with water before using to 
result in the appropriate fluoride concentration specified in the 
monograph.
    (l) Treatment rinse effervescent tablets. A fluoride treatment rinse 
prepared by adding an effervescent tablet (a concentrated solid dosage 
form) to water

[[Page 302]]

before using to result in the appropriate fluoride concentration 
specified in the monograph.
    (m) Treatment rinse powder. A fluoride treatment rinse prepared by 
adding the powder (a concentrated solid dosage form) to water before 
using to result in the appropriate fluoride concentration specified in 
the monograph.

[60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996]