[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: 21CFR358.301] [Page 310] 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. 358.301 Scope. Source: 68 FR 24348, May 7, 2003, unless otherwise noted. (a) An over-the-counter ingrown toenail relief drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in Sec. 330.1 of this chapter. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter 1 of title 21 unless otherwise noted.