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. A drug product applied to the skin or mucous membranes for a local and limited protein coagulant effect.
Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called “lip balm.”
Poison ivy, oak, sumac dermatitis. An allergic contact dermatitis due to exposure to plants of the genus Rhus (poison ivy, poison oak, poison sumac), which contain urushiol, a potent skin-sensitizer.
Skin protectant drug product. A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.
[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.
(1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to § 347.50(b)(1) and provided each ingredient in the combination is within the concentration specified in § 347.10.
(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. Aluminum sulfate tetradecahydrate may be combined with calcium acetate monohydrate in powder or tablet form to provide a 0.13 to 0.5 percent aluminum acetate solution when the powder or tablet is dissolved in the volume of water specified in “Directions.”
(c) Combinations of skin protectant and external analgesic active ingredients. Any one (two when required to be in combination) or more of the active ingredients identified in § 347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined with any of the following generally recognized as safe and effective external analgesic active ingredients: Single amine and “caine”-type local anesthetics, alcohols and ketones, antihistamines, or any permitted combination of these ingredients, but not with hydrocortisone, provided the product is labeled according to § 347.60(b)(l).
(d) Combinations of skin protectant and first aid antiseptic active ingredients. Any one (two when required to be in combination) or more of the active ingredients identified in § 347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined with any generally recognized as safe and effective single first aid antiseptic active ingredient, or any permitted combination of these ingredients, provided the product is labeled according to § 347.60(b)(2).
(e) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in combination) or more of the skin protectant active ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined with any generally recognized as safe and effective single sunscreen active ingredient, or any permitted combination of these ingredients, provided the product meets the conditions in § 352.20(b) of this chapter and is labeled according to §§ 347.60(b)(3) and 352.60(b) of this chapter.
[68 FR 33377, June 4, 2003, as amended at 74 FR 9765, Mar. 6, 2009]
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. 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”).
(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 § 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 § 347.10(a), (d), (e), (i), (k), (l), (m), and (r). The labeling states “temporarily protects minor: [bullet][1] cuts [bullet] scrapes [bullet] burns”.
(2) For products containing any ingredient in § 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 § 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 § 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 § 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 § 347.10(q). The labeling states “temporarily protects and helps relieve minor skin irritation”.
(7) For products containing the combination of ingredients in § 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 § 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. The labeling of the product contains the following statements, as appropriate, under the heading “Directions”:
(1) For products labeled according to § 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 § 347.10(f) —
(i) For products requiring dispersal in water. The labeling states “[bullet] turn warm water faucet on to full force [bullet] 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 § 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 § 347.10(b). The labeling states “[bullet] children under 6 months: ask a doctor”.
(5) For products containing glycerin identified in § 347.10(h). The labeling states “[bullet] children under 6 months: ask a doctor”.
(6) For products containing zinc acetate identified in § 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 § 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 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
