[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.303]

[Page 310-311]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 358_MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN 
USE--Table of Contents
 
             Subpart D_Ingrown Toenail Relief Drug Products
 
Sec.  358.303  Definitions.

    As used in this subpart:
    (a) Ingrown toenail relief drug product. A drug product applied to 
an ingrown toenail that relieves pain or discomfort either by softening 
the nail or by hardening the nail bed.
    (b) Retainer ring. A die cut polyethylene foam pad coated on one 
side with medical grade acrylic pressure-

[[Page 311]]

sensitive adhesive. The retainer ring has slots, center-cut completely 
through the foam with the cut of sufficient size to allow for 
localization of an active ingredient in a gel vehicle to a specific 
target area. The retainer ring is used with adhesive bandage strips to 
place over the retainer ring to hold it in place.