[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: 21CFR358.350]

[Page 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.  358.350  Labeling of ingrown toenail relief drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the product, if any, and identifies the product as 
an ``ingrown toenail relief product'' or as an ``ingrown toenail 
discomfort reliever.''
    (b) Indications. The labeling of the product states, under the 
heading ``Use,'' the following: ``for temporary relief of'' [select one 
or both of the following: 'pain' or 'discomfort'] ``from ingrown 
toenails''. Other truthful and nonmisleading statements, describing only 
the use that has been established and listed in this paragraph (b), may 
also be used, as provided in Sec.  330.1(c)(2) of this chapter, subject 
to the provisions of section 502 of the Federal Food, Drug, and Cosmetic 
Act (the act) relating to misbranding and the prohibition in section 
301(d) of the act against the introduction or delivery for introduction 
into interstate commerce of unapproved new drugs in violation of section 
505(a) of the act.
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) ``For external use only'' in accord with Sec.  201.66(c)(5)(i) 
of this chapter.
    (2) ``Do not use [bullet]\1\ on open sores''.
---------------------------------------------------------------------------

    \1\See Sec.  201.66(b)(4) of this chapter for definition of bullet.
---------------------------------------------------------------------------

    (3) ``Ask a doctor before use if you have [bullet] diabetes [bullet] 
poor circulation [bullet] gout''.
    (4) ``When using this product [bullet] use with a retainer ring''.
    (5) ``Stop use and ask a doctor if [bullet] redness or swelling of 
your toe increases [bullet] discharge is present around the nail 
[bullet] symptoms last more than 7 days or clear up and occur again 
within a few days''.
    (d) Directions. The labeling of the product contains the following 
statements under the heading ``Directions'':
    (1) ``[Bullet] adults and children 12 years and over:''
    (i) ``[Bullet] wash the affected area and dry thoroughly [bullet] 
place retainer ring on toe with slot over the area where the ingrown 
nail and the skin meet. Smooth ring down firmly. [bullet] apply enough 
gel product to fill the slot in the ring [bullet] place round center 
section of bandage strip directly over the gel-filled ring to seal the 
gel in place. Smooth ends of bandage strip around toes.''
    (ii) ``[Bullet] repeat twice daily (morning and night) for up to 7 
days until discomfort is relieved or until the nail can be lifted out of 
the nail groove and easily trimmed''.
    (2) ``[Bullet] children under 12 years: ask a doctor''.

Subpart E [Reserved]