21 C.F.R. § 347.52 Labeling of astringent drug products.
Title 21 - Food and Drugs
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent.” (b) Indications. The labeling of the product states, under the heading “Uses” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in §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 of 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 products containing aluminum acetate identified in §347.12(a). “For temporary relief of minor skin irritations due to: [select one or more of the following: ‘poison ivy,’ ‘poison oak,’ ‘poison sumac,’ ‘insect bites,’ ‘athlete's foot,’ or ‘rashes caused by soaps, detergents, cosmetics, or jewelry’].” (2) For products containing aluminum sulfate identified in §347.12(b) for use as a styptic pencil. “Stops bleeding caused by minor surface cuts and abrasions as may occur during shaving.” (3) For products containing witch hazel identified in §347.12(c). “Relieves minor skin irritations due to: [select one or more of the following: 'insect bites,' 'minor cuts,' or 'minor scrapes'].” [If more than one condition is used, each is preceded by a bullet.] (c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”: (1) “For external use only. Avoid contact with the eyes.” (2) For products containing aluminum acetate identified in §347.12(a) or witch hazel identified in §347.12(c). “If condition worsens or symptoms persist for more than 7 days, discontinue use of the product and consult a” [select one of the following: 'physician' or 'doctor'].” (3) For products containing aluminum acetate identified in §347.12(a) used as a compress or wet dressing. “Do not cover compress or wet dressing with plastic to prevent evaporation.” (4) For products containing aluminum acetate identified in §347.12(a) when labeled for use as a soak, compress, or wet dressing. “When using this product [bullet] in some skin conditions, soaking too long may overdry”. (d) Directions. The labeling of the product contains the following information under the heading “Directions”: (1) For products containing aluminum acetate identified in §347.12(a)—(i) For products used as a soak. “For use as a soak: [bullet] soak affected area for 15 to 30 minutes as needed, or as directed by a doctor [bullet] repeat 3 times a day or as directed by a doctor [bullet] discard solution after each use”. (ii) For products used as a compress or wet dressing. “For use as a compress or wet dressing: [bullet] soak a clean, soft cloth in the solution [bullet] apply cloth loosely to affected area for 15 to 30 minutes [bullet] repeat as needed or as directed by a doctor [bullet] discard solution after each use”. (2) For products containing aluminum sulfate identified in §347.12(b) for use as a styptic pencil. “Moisten tip of pencil with water and apply to the affected area. Dry pencil after use.” (3) For products containing witch hazel identified in §347.12(c). “Apply as often as needed”. (e) Products formulated and labeled as a styptic pencil and that meet the criteria established in §201.66(d)(10) of this chapter. The title, headings, subheadings, and information described in §201.66(c) of this chapter shall be printed in accordance with the following specifications: (1) The labeling shall meet the requirements of §201.66(c) of this chapter except that the headings and information described in §201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in §201.66(c)(4) and (c)(5) may be presented as follows: (i) The heading and indication required by §201.66(c)(4) of this chapter may be limited to: “Use [in bold type] stops bleeding of minor cuts from shaving”. (ii) The “external use only” warning in §347.52(c)(1) and in §201.66(c)(5)(i) of this chapter may be omitted. The second warning in §347.52(c)(1) may state: “avoid contact with eyes”. The warning in §201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in §201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph. (2) The labeling shall be printed in accordance with the requirements of §201.66(d) of this chapter except that any requirements related to §201.66(c)(3) and (c)(7), and the horizontal barlines and hairlines described in §201.66(d)(8), may be omitted. [68 FR 33377, June 4, 2003, as amended at 68 FR 35293, June 13, 2003; 69 FR 3005, Jan. 22, 2004]
Title 21: Food and Drugs
PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart C—Labeling
§ 347.52 Labeling of astringent drug products.
