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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2018]
[CITE: 21CFR347.52]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 347 -- SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C--Labeling

Sec. 347.52 Labeling of astringent 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 an "astringent." For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b) , under the "Purpose" heading identified in 201.66(c)(3) of this chapter, the labeling of each active ingredient in the product states "Astringent*", which is followed by the statements "* When combined together in water, these ingredients form the active ingredient aluminum acetate. See [the following in bold italic type] Directions."

(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) or the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b). "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 all products --(i) The labeling states "For external use only".

(ii) The labeling states "When using this product [bullet] avoid contact with eyes. If contact occurs, rinse thoroughly with water."

(2) For products containing aluminum acetate identified in 347.12(a), witch hazel identified in 347.12(c), or the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b). The labeling states "Stop use and ask a doctor if [bullet] condition worsens or symptoms last more than 7 days".

(3) For products containing aluminum acetate identified in 347.12(a) or the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b) when labeled for use as a compress or wet dressing. The labeling states "When using this product [bullet] do not cover compress or wet dressing with plastic to prevent evaporation".

(4) For products containing aluminum acetate identified in 347.12(a) or the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b) when labeled for use as a soak, compress, or wet dressing. The labeling states "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) or the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b) --(i) For products used as a soak. "For use as a soak: [preceding words in bold type] [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: [preceding words in bold type] [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".

(4) For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in 347.20(b) --(i) For powder dosage form. The labeling states "[bullet] dissolve 1 to 3 packets in [insert volume] of cool or warm water [bullet] stir until fully dissolved; do not strain or filter. The resulting mixture contains [insert percent] (1 packet), [insert percent] (2 packets), or [insert percent] (3 packets) aluminum acetate and is ready for use." These statements shall be the first statements under the heading "Directions".

(ii) For tablet dosage form. The labeling states "[bullet] dissolve 1 to 3 tablets in [insert volume] of cool or warm water [bullet] stir until fully dissolved; do not strain or filter. The resulting mixture contains [insert percent] (1 tablet), [insert percent] (2 tablets), or [insert percent] (3 tablets) aluminum acetate and is ready for use." These statements shall be the first statements under the heading "Directions".

(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; 74 FR 9765, Mar. 6, 2009]

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