[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.303]

[Page 59-60]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
  Subpart G--Specific Labeling Requirements for Specific Drug Products
 
Sec. 201.303  Labeling of drug preparations containing significant proportions of wintergreen oil.

    (a) Because methyl salicylate (wintergreen oil) manifests no 
toxicity in the minute amounts in which it is used as a flavoring, it is 
mistakenly regarded by the public as harmless even when taken in 
substantially larger amounts. Actually, it is quite toxic when taken in 
quantities of a teaspoonful or more. Wintergreen oil and preparations 
containing it have caused a number of deaths through accidental misuse 
by both adults and children. Children are particularly attracted by the 
odor and are likely to swallow these products when left within reach.
    (b) To safeguard against fatalities from this cause, the Department 
of Health and Human Services will regard as misbranded under the 
provisions of

[[Page 60]]

the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 
percent methyl salicylate (wintergreen oil), the labeling of which fails 
to warn that use otherwise than as directed therein may be dangerous and 
that the article should be kept out of reach of children to prevent 
accidental poisoning.
    (c) This statement of interpretation in no way exempts methyl 
salicylate (wintergreen oil) or its preparations from complying in all 
other respects with the requirements of the Federal Food, Drug, and 
Cosmetic Act.