[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: 21CFR357.152]

[Page 307]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 357_MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE--Table of Contents
 
                  Subpart B_Anthelmintic Drug Products
 
Sec. 357.152  Package inserts for anthelmintic drug products.

    The labeling of the product contains a consumer package insert which 
includes the following information:
    (a) A discussion of the symptoms suggestive of pinworm infestation, 
including a statement that pinworms must be visually identified before 
taking this medication.
    (b) A detailed description of how to find and identify the pinworm.
    (c) A commentary on the life cycle of the pinworm.
    (d) A commentary on the ways in which pinworms may be spread from 
person to person and hygienic procedures to follow to avoid such 
spreading.
    (e) The appropriate labeling information contained in Sec. 357.150

(Collection of information requirement approved by the Office of 
Management and Budget under control number 0910-0232)

[51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan 23, 1987]