[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.303]
[Page 77]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
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 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.
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