CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART D—Ingrown Toenail Relief Drug Products (§358.301 to §358.350) > 358.303—Definitions.

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-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.