[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.50]

[Page 263-266]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 346--ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 346.50  Labeling of anorectal drug products.


    The labeling of the product contains the following information for 
anorectal ingredients identified in Secs. 346.10, 346.12, 346.14, 
346.16, 346.18, and 346.20, and for combinations of anorectal 
ingredients identified in Sec. 346.22. Unless otherwise specified, the 
labeling in this subpart is applicable to anorectal drug products for 
both external and intrarectal use.
    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as 
``anorectal (hemorrhoidal),'' ``hemorrhoidal,'' ``hemorrhoidal 
(anorectal) (insert dosage form, e.g., cream, lotion, or ointment).''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' any of the phrases listed in paragraph (b) of 
this section, as appropriate. Other truthful and nonmisleading 
statements, describing only the indications for use that have been 
established and listed in this paragraph, 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 temporary relief of,'' ``Gives temporary relief of,'' 
or ``Helps

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relieve the'') (As an option, select one or both of the following: 
``local'' or ``anorectal'') [select one or more of the following: 
``discomfort,'' ``itching,'' or ``itching and discomfort,'' followed by: 
``in the perianal area'' or ``associated with'' (select one or more of 
the following: ``hemorrhoids,'' ``anorectal disorders,'' ``inflamed 
hemorrhoidal tissues,'' ``anorectal inflammation,'' ``hemorrhoidal 
tissues,'' or ``piles (hemorrhoids).'')]
    (2) Additional indications. Indications applicable to each active 
ingredient of the product may be combined to eliminate duplicative words 
or phrases so that the resulting indication is clear and understandable. 
In addition to the indication identified in paragraph (b)(1) of this 
section, the labeling of the product intended for external or 
intrarectal use may also contain the following indications, as 
appropriate.
    (i) For products for external use only containing any ingredient 
identified in Sec. 346.10. ``For the temporary relief of'' (select one 
or more of the following: ``pain,'' ``soreness,'' or ``burning'').
    (ii) For products containing epinephrine or epinephrine 
hydrochloride identified in Sec. 346.12 (b) and (c) for external use 
only, and for products containing ephedrine sulfate or phenylephrine 
hydrochloride identified in Sec. 346.12 (a) and (d).
    (A) ``Temporarily reduces the swelling associated with'' (select one 
of the following: ``irritated hemorrhoidal tissue and other anorectal 
disorders'' or ``irritation in hemorrhoids and other anorectal 
disorders'').
    (B) ``Temporarily shrinks hemorrhoidal tissue.''
    (iii) For products for external use only containing glycerin 
identified in Sec. 346.14(a)(3) and for products for external and/or 
intrarectal use containing any protectant identified in Sec. 346.14(a) 
(2), (4), (6) through (10), and (b) (1) through (4).
    (A) ``Temporarily forms a protective coating over inflamed tissues 
to help prevent drying of tissues.''
    (B) ``Temporarily protects irritated areas.''
    (C) ``Temporarily relieves burning.''
    (D) ``Provides temporary relief from skin irritations.''
    (E) ``Temporarily provides a coating for relief of anorectal 
discomforts.''
    (F) ``Temporarily protects the inflamed, irritated anorectal 
surface'' (select one of the following: ``to help make bowel movements 
less painful'' or ``from irritation and abrasion during bowel 
movement'').
    (G) ``Temporarily protects inflamed perianal skin.''
    (H) ``Temporarily relieves the symptoms of perianal skin 
irritation.''
    (iv) For products containing aluminum hydroxide gel identified in 
Sec. 346.14(a)(1) and for products containing kaolin identified in 
Sec. 346.14(a)(5). ``For the temporary relief of itching associated with 
moist anorectal conditions.''
    (v) For products for external use only containing any analgesic, 
anesthetic, and antipruritic identified in Sec. 346.16.
    (A) ``For the temporary relief of'' (select one or both of the 
following: ``pain'' or ``burning'').
    (B) ``Can help distract from pain.''
    (C) ``May provide a cooling sensation.''
    (vi) For products for external use only containing witch hazel 
identified in Sec. 346.18(b), and for products for external use and/or 
intrarectal use containing calamine or zinc oxide identified in 
Sec. 346.18 (a) and (c).
    (A) ``Aids in protecting irritated anorectal areas.''
    (B) ``Temporary relief of'' (select one or both of the following: 
``irritation'' or ``burning'').
    (vii) For products for external use only containing any ingredient 
identified in Sec. 346.20. The indication in paragraph (b)(1) of this 
section applies.
    (c) Warnings. Warnings applicable to each active ingredient of the 
product may be combined to eliminate duplicative words or phrases so 
that the resulting warning is clear and understandable. The labeling of 
the product contains the following warnings under the heading 
``Warnings'':
    (1) ``If condition worsens or does not improve within 7 days, 
consult a doctor.''
    (2) ``Do not exceed the recommended daily dosage unless directed by 
a doctor.''
    (3) ``In case of bleeding, consult a doctor promptly.''

[[Page 265]]

    (4) For products for external use only. ``Do not put this product 
into the rectum by using fingers or any mechanical device or 
applicator.''
    (5) For products for intrarectal use to be used with a special 
applicator such as a pile pipe or other mechanical device. ``Do not use 
this product with an applicator if the introduction of the applicator 
into the rectum causes additional pain. Consult a doctor promptly.''
    (6) For products for external use only containing any local 
anesthetic identified in Sec. 346.10, menthol identified in 
Sec. 346.16(c), or resorcinol identified in Sec. 346.20(b). ``Certain 
persons can develop allergic reactions to ingredients in this product. 
If the symptom being treated does not subside or if redness, irritation, 
swelling, pain, or other symptoms develop or increase, discontinue use 
and consult a doctor.''
    (7) For products containing any vasoconstrictor identified in 
Sec. 346.12. (i) ``Do not use this product if you have heart disease, 
high blood pressure, thyroid disease, diabetes, or difficulty in 
urination due to enlargement of the prostate gland unless directed by a 
doctor.''
    (ii) ``Ask a doctor or pharmacist before use if you are [bullet]\1\ 
presently taking a prescription drug for high blood pressure or 
depression.''
---------------------------------------------------------------------------

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

    (iii) For products containing ephedrine sulfate identified in 
Sec. 346.12(a). ``Some users of this product may experience nervousness, 
tremor, sleeplessness, nausea, and loss of appetite. If these symptoms 
persist or become worse, consult your doctor.''
    (8) For products containing aluminum hydroxide gel identified in 
Sec. 346.14(a)(1) and for products containing kaolin identified in 
Sec. 346.14(a)(5). ``Remove petrolatum or greasy ointment before using 
this product because they interfere with the ability of this product to 
adhere properly to the skin area.''
    (9) For products for external use only containinq resorcinol 
identified in Sec. 346.20(b). ``Do not use on open wounds near the 
anus.''
    (d) Directions. Directions applicable to each active ingredient of 
the product may be combined to eliminate duplicative words or phrases so 
that the resulting information is clear and understandable. The labeling 
of the product contains the following information under the heading 
``Directions'':
    (1) ``Adults: When practical, cleanse the affected area'' (select 
one or both of the following: ``with mild soap and warm water and rinse 
thoroughly'' or ``by patting or blotting with an appropriate cleansing 
pad''). ``Gently dry by patting or blotting with toilet tissue or a soft 
cloth before application of this product.'' [Other appropriate 
directions in this section may be inserted here.] ``Children under 12 
years of age: consult a doctor.''
    (2) For products for external use only. ``Apply externally to the 
affected area'' (insert appropriate time interval of administration as 
identified in paragraphs (d)(6), (7), (8), or (9) of this section).
    (3) For products for external use that are pads containing anorectal 
ingredients. ``Gently apply to the affected area by patting and then 
discard.''
    (4) For products for intrarectal use that are wrapped suppositories. 
``Remove wrapper before inserting into the rectum.''
    (5) For products for intrarectal use that are to be used with a 
special applicator such as a pile pipe or other mechanical device. ``FOR 
INTRARECTAL USE: Attach applicator to tube. Lubricate applicator well, 
then gently insert applicator into the rectum.''
    (6) For products for external use only containing any of the local 
anesthetics identified in Sec. 346.10; analgesics, anesthetics, and 
antipruritics identified in Sec. 346.16; or alcloxa or resorcinol 
identified in Sec. 346.20. Apply to the affected area up to 6 times 
daily.
    (i) For products for external use only containing dibucaine or 
dibucaine hydrochloride identified in Sec. 346.10 (c) and (d). Apply to 
the affected area up to 3 or 4 times daily.
    (ii) For products for external use only containing pramoxine 
hydrochloride identified in Sec. 346.10(g). Apply to the affected area 
up to 5 times daily.
    (7) For products containing vasoconstrictors identified in 
Sec. 346.12. Apply to the affected area up to 4 times daily.
    (8) For products for external use only containing glycerin 
identified in Sec. 346.14(a)(3) or witch hazel identified in 
Sec. 346.18(b), and for products for external

[[Page 266]]

and/or intrarectal use containing any protectant identified in 
Sec. 346.14(a)(1), (2), (4), (5), (6), (7), and (9), and (b)(1), (2), 
(3), and (4), or any astringent identified in Sec. 346.18(a) and (c). 
Apply to the affected area up to 6 times daily or after each bowel 
movement.
    (9) For products containing petrolatum or white petrolatum 
identified in Sec. 346.14(a)(8) and (10). Apply liberally to the 
affected area as often as necessary.
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.

[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994; 64 
FR 13295, Mar. 17, 1999]