[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: 21CFR358.550]

[Page 312-313]
 
                        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 F_Corn and Callus Remover Drug Products
 
Sec.  358.550  Labeling of corn and callus remover drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as a 
``corn and callus remover.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' the phrase listed in paragraph (b)(1) of this 
section and may contain the additional phrase listed in paragraph (b)(2) 
of this section. Other truthful and nonmisleading statements, describing 
only the indications for use that have been established in paragraph (b) 
of this section, 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.
    (1) ``For the removal of corns and calluses.''
    (2) In addition to the information identified in paragraph (b)(1) of 
this section, the labeling of the product may contain the following 
statement: ``Relieves pain by removing corns and calluses.''
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) For products containing any ingredient identified in Sec.  
358.510. (i) ``For external use only.''
    (ii) ``Do not use this product on irritated skin, on any area that 
is infected or reddened, if you are a diabetic, or if you have poor 
blood circulation.''
    (iii) ``If discomfort persists, see your doctor or podiatrist.''
    (2) For any product formulated in a flammable vehicle. (i) The 
labeling should contain an appropriate flammability signal word, e.g., 
``extremely flammable,'' ``flammable,'' ``combustible,'' consistent with 
16 CFR 1500.3(b)(10).
    (ii) ``Keep away from fire or flame.''
    (3) For any product formulated in a volatile vehicle. ``Cap bottle 
tightly and store at room temperature away from heat.''
    (4) For any product formulated in a collodion-like vehicle. (i) ``If 
product gets into the eye, flush with water for 15 minutes.''
    (ii) ``Avoid inhaling vapors.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) For products containing salicylic acid identified in Sec.  
358.510(a). ``Wash affected area and dry thoroughly.'' (If appropriate: 
``Cut plaster to fit corn/callus.'') ``Apply medicated plaster. After 48 
hours remove the medicated plaster. Repeat this procedure every 48 hours 
as needed for up to 14 days (until corn/callus is removed).'' (Optional: 
``May soak corn/callus in warm water for 5 minutes to assist in 
removal.'')
    (2) For products containing salicylic acid identified in Sec.  
358.510(b). ``Wash affected area and dry thoroughly. Apply'' (select one 
of the following, as appropriate: ``one drop'' or ``small amount'') ``at 
a time with'' (select one of the following, as appropriate: 
``applicator'' or ``brush'') ``to sufficiently cover each corn/callus. 
Let dry. Repeat this procedure once or twice daily as needed for up to 
14 days (until corn/callus is removed).'' (Optional: ``May soak corn/

[[Page 313]]

callus in warm water for 5 minutes to assist in removal.'')
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.

[55 FR 33261, Aug. 14, 1990, as amended at 57 FR 44494, Sept. 28, 1992]