[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR355.60]

[Page 289]
 
                        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 C--Labeling
 
Sec. 355.60  Professional labeling.

    (a) The labeling for anticaries fluoride treatment rinses identified 
in Sec. 355.10(a)(3) and (c)(3) that are specially formulated so they 
may be swallowed (fluoride supplements) and are provided to health 
professionals (but not to the general public) may contain the following 
additional dosage information: Children 3 to under 14 years of age: As a 
supplement in areas where the water supply is nonfluoridated (less than 
0.3 parts per million (ppm)), clean the teeth with a toothpaste and 
rinse with 5 milliliters (mL) of 0.02 percent or 10 mL of 0.01 percent 
fluoride ion rinse daily, then swallow. When the water supply contains 
0.3 to 0.7 ppm fluoride ion, reduce the dose to 2.5 mL of 0.02 percent 
or 5 mL of 0.01 percent fluoride ion rinse daily.
    (b) The labeling for products marketed to health to health 
professionals in package sizes larger than those specified in 
Sec. 355.20 shall include the statements: ``For Professional Office Use 
Only'' and ``This product is not intended for home or unsupervised 
consumer use.''