[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.150]

[Page 310-311]
 
                        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--
 
                  Subpart B_Wart Remover Drug Products
 
Sec.  358.150  Labeling of wart 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 
``wart remover.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' any of the phrases listed in paragraph (b) 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 common warts. The common wart is easily 
recognized by the rough `cauliflower-like' appearance of the surface.''
    (2) ``For the removal of plantar warts on the bottom of the foot. 
The plantar wart is recognized by its location only on the bottom of the 
foot, its tenderness, and the interruption of the footprint pattern.''
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':

[[Page 311]]

    (1) For products containing any ingredient identified in Sec.  
358.110. (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.''
    (iv) ``Do not use on moles, birthmarks, warts with hair growing from 
them, genital warts, or warts on the face or mucous membranes.''
    (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.  
358.110(a). ``Wash affected area.'' (Optional: ``May soak wart in warm 
water for 5 minutes.'') ``Dry area thoroughly.'' (If appropriate: ``Cut 
plaster to fit wart.'') ``Apply medicated plaster. Repeat procedure 
every 48 hours as needed (until wart is removed) for up to 12 weeks.''
    (2) For products containing salicylic acid identified in Sec.  
358.110(b). ``Wash affected area.'' (Optional: ``May soak wart in warm 
water for 5 minutes.'') ``Dry area 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 wart. Let dry. Repeat this 
procedure once or twice daily as needed (until wart is removed) for up 
to 12 weeks.''
    (3) For products containing salicylic acid identified in Sec.  
358.110(c). ``Wash affected area.'' (Optional: ``May soak wart in warm 
water for 5 minutes.'') ``Dry area thoroughly. Gently smooth wart 
surface with emery file supplied.'' (If appropriate: ``Cut plaster to 
fit wart.'') ``Apply a drop of warm water to the wart, keeping the 
surrounding skin dry. Apply medicated plaster at bedtime and leave in 
place for at least 8 hours. In the morning, remove plaster and discard. 
Repeat procedure every 24 hours as needed (until wart is removed) for up 
to 12 weeks.''
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.
    (f) The phrase ``or podiatrist'' may be used in addition to the word 
``doctor'' in any of the labeling statements in this section when a 
product is labeled with the indication identified in Sec.  
358.150(b)(2).

[55 FR 33255, Aug. 14, 1990; 55 FR 37403, Sept. 11, 1990, as amended at 
57 FR 44495, Sept. 28, 1992; 59 FR 60317, Nov. 23, 1994]

Subpart C [Reserved]