[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR357.152]

[Page 290-291]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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.

[[Page 291]]

    (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]