[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2008] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR347.50] [Page 276-279] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF PART 347_SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents Subpart C_Labeling Sec. 347.50 Labeling of skin protectant drug products. Source: 68 FR 33377, June 4, 2003, unless otherwise noted. 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. The labeling of the product contains the established name of the drug, if any, and identifies the product with one or more of the following: (1) For any product. ``Skin protectant'' (optional, may add dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment''). (2) For any product formulated as a lip protectant. ``Skin protectant,'' ``lip protectant,'' or ``lip balm'' (optional, may add dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment''). (3) For products containing any ingredient in Sec. 347.10(b), (c), (j), (s), (t), and (u). ``Poison ivy, oak, sumac drying'' (optional, may add dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment''). (4) For products containing any ingredient in Sec. 347.10(b), (c), (f), (j), (o), (s), (t), and (u). ``Poison ivy, oak, sumac protectant.'' (b) Indications. The labeling of the product states, under the heading ``Uses,'' one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), 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 products containing any ingredient in Sec. 347.10(a), (d), (e), (i), (k), (l), [[Page 277]] (m), and (r). The labeling states ``temporarily protects minor: [bullet]\1\ cuts [bullet] scrapes [bullet] burns''. --------------------------------------------------------------------------- \1\ See Sec. 201.66(b)(4) of this chapter for definition of bullet symbol. --------------------------------------------------------------------------- (2) For products containing any ingredient in Sec. 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r)--(i) The labeling states (optional: ``helps prevent and'') ``temporarily protects'' (optional: ``and helps relieve'') (optional: ``chafed,'') ``chapped or cracked skin'' (optional: ``and lips''). This statement may be followed by the optional statement: ``helps'' (optional: ``prevent and'') ``protect from the drying effects of wind and cold weather''. [If both statements are used, each is preceded by a bullet.] (ii) For products formulated as a lip protectant. The labeling states (optional: ``helps prevent and'') ``temporarily protects'' (optional: ``and helps relieve'') (optional: ``chafed,'') ``chapped or cracked lips''. This statement may be followed by the optional statement: ``helps'' (optional: ``prevent and'') ``protect from the drying effects of wind and cold weather''. [If both statements are used, each is preceded by a bullet.] (3) For products containing any ingredient in Sec. 347.10(b), (c), (j), (s), (t), and (u). The labeling states ``dries the oozing and weeping of poison: [bullet] ivy [bullet] oak [bullet] sumac''. (4) For products containing colloidal oatmeal identified in Sec. 347.10(f). The labeling states ``temporarily protects and helps relieve minor skin irritation and itching due to: [select one or more of the following: `[bullet] rashes' `[bullet] eczema' `[bullet] poison ivy, oak, or sumac' `[bullet] insect bites'].'' (5) For products containing sodium bicarbonate identified in Sec. 347.10(o). The labeling states ``temporarily protects and helps relieve minor skin irritation and itching due to: [bullet] poison ivy, oak, or sumac [bullet] insect bites''. (6) For products containing topical starch identified in Sec. 347.10(q). The labeling states ``temporarily protects and helps relieve minor skin irritation''. (7) For products containing the combination of ingredients in Sec. 347.20(a)(4). The labeling states ``temporarily protects and helps relieve minor skin irritation and itching due to: [select one or more of the following: `rashes' or `eczema'].'' [If both conditions are 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'' in accord with Sec. 201.66(c)(5)(i) of this chapter. For products containing only mineral oil in Sec. 347.10(l) or sodium bicarbonate in Sec. 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 Sec. 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 Sec. 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 Sec. 347.10(j) or topical starch identified in Sec. 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 Sec. 347.10(f) or sodium bicarbonate identified in Sec. 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. The labeling of the product contains the following statements, as appropriate, under the heading ``Directions'': (1) For products labeled according to Sec. 347.50(b)(1), (b)(2), (b)(3), (b)(5), or (b)(6). The labeling states ``apply as needed''. (2) For products containing colloidal oatmeal identified in Sec. 347.10(f)--(i) For products requiring dispersal in water. The labeling states ``[bullet] turn warm water faucet on to full force [bullet] [[Page 278]] slowly sprinkle'' (manufacturer to insert quantity to be used) ``of colloidal oatmeal directly under the faucet into the tub or container [bullet] stir any colloidal oatmeal settled on the bottom''. (A) For products used as a soak in a bath. The manufacturer must provide adequate directions to obtain a solution containing a minimum of 0.007 percent colloidal oatmeal or 0.003 percent colloidal oatmeal in the oilated form for a tub bath, sitz bath, or infant bath, or a minimum of 0.25 percent colloidal oatmeal for a foot bath. ``For use as a soak in a bath: [bullet] soak affected area for 15 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''. (B) For products used as a compress or wet dressing. The manufacturer must provide adequate directions to obtain a solution containing a minimum of 0.25 percent colloidal oatmeal. ``For use as a compress or wet dressing: [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''. (ii) For topical products intended for direct application. The labeling states ``apply as needed''. (3) For products containing sodium bicarbonate identified in Sec. 347.10(o). The labeling states ``[bullet] adults and children 2 years of age and over:'' (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 Sec. 347.10(b). The labeling states ``[bullet] children under 6 months: ask a doctor''. (5) For products containing glycerin identified in Sec. 347.10(h). The labeling states ``[bullet] children under 6 months: ask a doctor''. (6) For products containing zinc acetate identified in Sec. 347.10(s). The labeling states ``[bullet] children under 2 years: ask a doctor''. (e) Products formulated and labeled as a lip protectant and that meet the criteria established in Sec. 201.66(d)(10) of this chapter. The title, headings, subheadings, and information described in Sec. 201.66(c) of this chapter shall be printed in accordance with the following specifications: (1) The labeling shall meet the requirements of Sec. 201.66(c) of this chapter except that the title, headings, and information described in Sec. 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in Sec. 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows: (i) The active ingredients (Sec. 201.66(c)(2) of this chapter) shall be listed in alphabetical order. (ii) The heading and the indication required by Sec. 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 Sec. 347.50(c)(1) and in Sec. 201.66(c)(5)(i) of this chapter may be omitted. The warnings in Sec. 347.50(c)(2), (c)(3), and (c)(4) are not required. (iv) The subheadings in Sec. 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 Sec. 347.50(e)(1)(iii). [[Page 279]] (v) The warnings in Sec. 201.66(c)(5)(x) of this chapter may be omitted. (2) The labeling shall be printed in accordance with the requirements of Sec. 201.66(d) of this chapter except that any requirements related to Sec. 201.66(c)(1), (c)(3), (c)(6), and (c)(7), and the horizontal barlines and hairlines described in Sec. 201.66(d)(8), may be omitted. (f) Products containing only cocoa butter, petrolatum, or white petrolatum identified in Sec. 347.10(d), (m), and (r), singly or in combination with each other, and marketed other than as a lip protectant. (1) The labeling shall meet the requirements of Sec. 201.66(c) of this chapter except that the headings and information described in Sec. 201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in Sec. 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows: (i) The active ingredients (Sec. 201.66(c)(2) of this chapter) shall be listed in alphabetical order. (ii) The heading and the indication required by Sec. 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 Sec. 347.50(c)(3) may be revised to read ``See a doctor if condition lasts more than 7 days.'' (iv) The subheadings in Sec. 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 Sec. 347.50(c)(2), (c)(4), and (f)(1)(iii). (2) The labeling shall be printed in accordance with the requirements of Sec. 201.66(d) of this chapter except that any requirements related to Sec. 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]