[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: 21CFR310.538]

[Page 34]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 310_NEW DRUGS--Table of Contents
 
        Subpart E_Requirements for Specific New Drugs or Devices
 
Sec. 310.538  Drug products containing active ingredients offered
over-the-counter (OTC) for use for ingrown toenail relief.

    (a) Any product that bears labeling claims such as for ``temporary 
relief of discomfort from ingrown toenails,'' or ``ingrown toenail 
relief product,'' or ``ingrown toenail reliever,'' or similar claims is 
considered an ingrown toenail relief drug product. Benzocaine, 
chlorobutanol, chloroxylenol, dibucaine, tannic acid, and urea have been 
present as ingredients in such products. There is lack of adequate data 
to establish general recognition of the safety and effectiveness of 
these or any other ingredients for OTC use for ingrown toenail relief. 
Based on evidence currently available, any OTC drug product containing 
ingredients offered for use for ingrown toenail relief cannot be 
generally recognized as safe and effective.
    (b) Any OTC drug product that is labeled, represented, or promoted 
for ingrown toenail relief is regarded as a new drug within the meaning 
of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), 
for which an approved application or abbreviated application under 
section 505 of the act and part 314 of this chapter is required for 
marketing. In the absence of an approved new drug application or 
abbreviated new drug application, such product is also misbranded under 
section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product labeled, represented, or promoted for OTC use for ingrown 
toenail relief is safe and effective for the purpose intended must 
comply with the requirements and procedures governing the use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) After March 9, 1994, any such OTC drug product initially 
introduced or initially delivered for introduction into interstate 
commerce that is not in compliance with this section is subject to 
regulatory action.
    (e) This section does not apply to sodium sulfide labeled, 
represented, or promoted for OTC topical use for ingrown toenail relief 
in accordance with part 358, subpart D of this chapter, after June 6, 
2003.

[58 FR 47605, Sept. 9, 1993, as amended at 68 FR 24348, May 7, 2003]