U.S. Food & Drug Administration
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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revid as of April 1, 2012]
[CITE: 21CFR347]
PART 347SKIN PROTECTANT DRUG PRODUCTS FOR OVER-
THE-COUNTER HUMAN USE
Subpart A--General Provisions
Sec. 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.
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光明歌曲歌词(b) References in this part to regulatory ctions of the Code of
Federal Regulations are to chapter I of title 21 unless otherwi noted.
Sec. 347.3 Definitions.
As ud 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 expod 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-nsitizer.
Skin protectant drug product. A drug product that temporarily protects injured or expod 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
Sec. 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 ud in
a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400
U.S.P. Units cholecalciferol.
CFR - Code of Federal Regulations Title21 FDA Home3Medical Devices4Databas5
(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) [Rerved]抒情古诗
(o) Sodium bicarbonate.
(p) [Rerved]
(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.
Sec. 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 ud by the consumer contains 0.13 to 0.5 percent aluminum acetate).
(b) Aluminum sulfate, 46 to 63 percent (the concentration is bad on
the anhydrous equivalent).
(c) Witch hazel.
Sec. 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 the ingredients, but not with hydrocortisone, provided the product is labeled according to
347.60(b)(l).
(d)Combinations of skin protectant and first aid antiptic 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 antiptic active ingredient, or any
permitted combination of the 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 the 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] 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
Sec. 347.50 Labeling of skin protectant drug products.
A skin protectant drug product may have more than one labeled u and labeling appropriate to different us may be combined to eliminate duplicative words or phras as long as the labeling is clear and understandable. When the labeling of the product contains more than one labeled u, 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,
<, "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").
hp打印机扫描(3)For products containing any ingredient in 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 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 "Us," one or more of the phras listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing
only the us that have been established and listed in this paragraph (b), may also be ud, as provided in 330.1(c)(2) of this chapter, subject to the provisions of ction 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in ction 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in
violation of ction 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]1cuts [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 ud, 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 ud, 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: [lect one or more of the following: ` [bullet] rashes' `[bullet] eczema' `[bullet] poison ivy, oak, or sumac' `[bullet] inct 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] inct 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: [lect one or more of the
following: `rashes' or `eczema']." [If both conditions are ud, each is preceded by a bullet.]
(c)Warnings. The labeling of the product contains the following warnings under the heading "Warnings":
(1) "For external u 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 u of the product is also provided.
(2) "When using this product [bullet] do not get into eyes".
(3) "Stop u and ask a doctor if [bullet] condition worns [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 u on [bullet] deep or puncture wounds [bullet] animal bites [bullet] rious burns".
(5) For products containing colloidal oatmeal identified in 347.10(f) when labeled for u as a soak in a tub. "When using this product [bullet] to avoid slipping, u 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 u 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 u 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 inrt quantity to be ud) "of colloidal oatmeal directly under the faucet into the tub or container [bullet]
stir any colloidal oatmeal ttled on the bottom".
(A)For products ud 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 u 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 ud as a compress or wet dressing. The manufacturer
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must provide adequate directions to obtain a solution containing a minimum of 0.25 percent colloidal oatmeal. "For u as a compress or wet dressing: [bullet] soak a clean, soft cloth in the mixture [bullet]
apply cloth looly to affected area for 15 to 30 minutes [bullet]
repeat as needed or as directed by a doctor [bullet] discard mixture
after each u".
(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 u 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 u 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 u 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 looly to affected area for 15 to 30 minutes [bullet]
repeat as needed or as directed by a doctor [bullet] discard mixture
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(iv) Any of the directions in paragraphs (d)(3)(i), (d)(3)(ii), or (d) (3)(iii) of this ction 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 prented 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: "U [in bold type] helps" (optional: "prevent and") "protect" (optional: "and relieve") "chapped lips". If both optional terms are ud, the indication may be limited to: "U [in bold type] helps prevent, protect, and relieve chapped lips".
(iii) The "external u 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).
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(v) The warnings in 201.66(c)(5)(x) of this chapter may be omitted.
市场推广(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 markete
d other than as a lip
protectant. (1) The labeling shall meet the requirements of 201.66(c) of this chapter except that the headings and information described in
