PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 58 FR 54462, Oct. 21, 1993, unless otherwise noted. Subpart A—General Provisions § 347.1 Scope. (a) An over-the-counter skin protectant drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 347.3 Definitions. As used in this part: Astringent drug product. Lip protectant drug product. Poison ivy, oak, sumac dermatitis. Skin protectant drug product. [68 FR 33376, June 4, 2003] Subpart B—Active Ingredients Source: 68 FR 33377, June 4, 2003, unless otherwise noted. § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient: (a) Allantoin, 0.5 to 2 percent. (b) Aluminum hydroxide gel, 0.15 to 5 percent. (c) Calamine, 1 to 25 percent. (d) Cocoa butter, 50 to 100 percent. (e) Cod liver oil, 5 to 13.56 percent, in accordance with § 347.20(a)(1) or (a)(2), provided the product is labeled so that the quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400 U.S.P. Units cholecalciferol. (f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4). (g) Dimethicone, 1 to 30 percent. (h) Glycerin, 20 to 45 percent. (i) Hard fat, 50 to 100 percent. (j) Kaolin, 4 to 20 percent. (k) Lanolin, 12.5 to 50 percent. (l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4). (m) Petrolatum, 30 to 100 percent. (n) [Reserved] (o) Sodium bicarbonate. (p) [Reserved] (q) Topical starch, 10 to 98 percent. (r) White petrolatum, 30 to 100 percent. (s) Zinc acetate, 0.1 to 2 percent. (t) Zinc carbonate, 0.2 to 2 percent. (u) Zinc oxide, 1 to 25 percent. § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient: (a) Aluminum acetate, 0.13 to 0.5 percent (depending on the formulation and concentration of the marketed product, the manufacturer must provide adequate directions so that the resulting solution to be used by the consumer contains 0.13 to 0.5 percent aluminum acetate). (b) Aluminum sulfate, 46 to 63 percent (the concentration is based on the anhydrous equivalent). (c) Witch hazel. § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (2) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to § 347.50(b)(2) and provided each ingredient in the combination is within the concentration specified in § 347.10. (3) Any two or more of the ingredients identified in § 347.10(b), (c), (j), (s), (t), and (u) may be combined provided the combination is labeled according to § 347.50(b)(3) and provided each ingredient in the combination is within the concentration specified in § 347.10. (4) The ingredients identified in § 347.10(f) and (l) may be combined provided the combination is labeled according to § 347.50(b)(7) and provided each ingredient in the combination is within the concentration specified in § 347.10. (b) Combination of ingredients to prepare an aluminum acetate solution. (c) Combinations of skin protectant and external analgesic active ingredients. (d) Combinations of skin protectant and first aid antiseptic active ingredients. (e) Combinations of skin protectant and sunscreen active ingredients. [68 FR 33377, June 4, 2003, as amended at 74 FR 9765, Mar. 6, 2009] Effective Date Note: At 68 FR 33377, June 4, 2003, in § 347.20 paragraph (d) was stayed until further notice, effective June 4, 2004. At 74 FR 9765, Mar. 6, 2009, in § 347.20, paragraph (d) was redesignated as paragraph (e). Subpart C—Labeling Source: 68 FR 33377, June 4, 2003, unless otherwise noted. § 347.50 Labeling of skin protectant drug products. A skin protectant drug product may have more than one labeled use and labeling appropriate to different uses may be combined to eliminate duplicative words or phrases as long as the labeling is clear and understandable. When the labeling of the product contains more than one labeled use, the appropriate statement(s) of identity, indications, warnings, and directions must be stated in the labeling. (a) Statement of identity. (1) For any product. (2) For any product formulated as a lip protectant. (3) For products containing any ingredient in § 347.10(b), (c), (j), (s), (t), and (u). (4) For products containing any ingredient in § 347.10(b), (c), (f), (j), (o), (s), (t), and (u). (b) Indications. (1) For products containing any ingredient in § 347.10(a), (d), (e), (i), (k), (l), (m), and (r). 1 1 See (2) For products containing any ingredient in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) The labeling states (ii) For products formulated as a lip protectant. (3) For products containing any ingredient in § 347.10(b), (c), (j), (s), (t), and (u). (4) For products containing colloidal oatmeal identified in § 347.10(f). (5) For products containing sodium bicarbonate identified in § 347.10(o). (6) For products containing topical starch identified in § 347.10(q). (7) For products containing the combination of ingredients in § 347.20(a)(4). (c) Warnings. (1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. For products containing only mineral oil in § 347.10(l) or sodium bicarbonate in § 347.10(o), this warning may be omitted if labeling for oral use of the product is also provided. (2) “When using this product [bullet] do not get into eyes”. (3) “Stop use and ask a doctor if [bullet] condition worsens [bullet] symptoms last more than 7 days or clear up and occur again within a few days”. (4) For products labeled according to § 347.50(b)(1) or (b)(2): “Do not use on [bullet] deep or puncture wounds [bullet] animal bites [bullet] serious burns”. (5) For products containing colloidal oatmeal identified in § 347.10(f) when labeled for use as a soak in a tub. “When using this product [bullet] to avoid slipping, use mat in tub or shower”. (6) For powder products containing kaolin identified in § 347.10(j) or topical starch identified in § 347.10(q)—(i) “Do not use on [bullet] broken skin”. (ii) “When using this product [bullet] keep away from face and mouth to avoid breathing it”. (7) For products containing colloidal oatmeal identified in § 347.10(f) or sodium bicarbonate identified in § 347.10(o) 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. (1) For products labeled according to § 347.50(b)(1), (b)(2), (b)(3), (b)(5), or (b)(6). (2) For products containing colloidal oatmeal identified in § 347.10(f) For products requiring dispersal in water. (A) For products used as a soak in a bath. (B) For products used as a compress or wet dressing. (ii) For topical products intended for direct application. (3) For products containing sodium bicarbonate identified in § 347.10(o). (i) The labeling states “For use as a paste: [bullet] add enough water to the sodium bicarbonate to form a paste [bullet] apply to the affected area of the skin as needed, or as directed by a doctor”. (ii) The labeling states “For use as a soak in a bath: [bullet] dissolve 1 to 2 cupfuls in a tub of warm water [bullet] soak for 10 to 30 minutes as needed, or as directed by a doctor [bullet] pat dry (do not rub) to keep a thin layer on the skin”. (iii) The labeling states “For use as a compress or wet dressing: [bullet] add sodium bicarbonate to water to make a mixture in a container [bullet] soak a clean, soft cloth in the mixture [bullet] apply cloth loosely to affected area for 15 to 30 minutes [bullet] repeat as needed or as directed by a doctor [bullet] discard mixture after each use”. (iv) Any of the directions in paragraphs (d)(3)(i), (d)(3)(ii), or (d)(3)(iii) of this section shall be followed by the statement: “[bullet] children under 2 years: ask a doctor”. (4) For products containing aluminum hydroxide gel identified in § 347.10(b). (5) For products containing glycerin identified in § 347.10(h). (6) For products containing zinc acetate identified in § 347.10(s). (e) Products formulated and labeled as a lip protectant and that meet the criteria established in § 201.66(d)(10) of this chapter. (1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows: (i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order. (ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”. (iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required. (iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii). (v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted. (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)(1), (c)(3), (c)(6), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted. (f) Products containing only cocoa butter, petrolatum, or white petrolatum identified in § 347.10(d), (m), and (r), singly or in combination with each other, and marketed other than as a lip protectant. (i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order. (ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to “Use [in bold type] helps protect minor cuts and burns” or “Use [in bold type] helps” (optional: “prevent and”) “protect chapped skin” or “Use [in bold type] helps protect minor cuts and burns and” (optional: “prevent and protect”) “chapped skin”. (iii) The warning in § 347.50(c)(3) may be revised to read “ See (iv) The subheadings in § 201.66(c)(5)(iv) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” contains the warnings in § 347.50(c)(2), (c)(4), and (f)(1)(iii). (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) may be omitted. [68 FR 33377, June 4, 2003, as amended at 68 FR 68511, Dec. 9, 2003; 73 FR 6017, Feb. 1, 2008] § 347.52 Labeling of astringent drug products. (a) Statement of identity. For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in § 347.20(b) (b) Indications. (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). (2) For products containing aluminum sulfate identified in § 347.12(b) for use as a styptic pencil. (3) For products containing witch hazel identified in § 347.12(c). (c) Warnings. (1) For all products (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). (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. (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. (d) 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) For products used as a soak. (ii) For products used as a compress or wet dressing. (2) For products containing aluminum sulfate identified in § 347.12(b) for use as a styptic pencil. (3) For products containing witch hazel identified in § 347.12(c). (4) For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in § 347.20(b) For powder dosage form. (ii) For tablet dosage form. (e) Products formulated and labeled as a styptic pencil and that meet the criteria established in § 201.66(d)(10) of this chapter. (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] § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. (b) Indications. (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). (2) Combinations of skin protectant and first aid antiseptic active ingredients in § 347.20(c). (3) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). (c) Warnings. (1) For combinations containing a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). (2) [Reserved] (d) Directions. (1) For combinations containing a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). (2) [Reserved]