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Subpart I—Deodorant Drug Products for Internal

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Subpart I—Deodorant Drug Products for Internal § 357.801 21 CFR Ch. I (4–1–10 Edition) of biliary ducts during cholecys- (b) Indications. The labeling of the tography.’’ product states, under the heading ‘‘In- dications,’’ any of the phrases listed in [54 FR 8321, Feb. 28, 1989] paragraph (b) of this section as appro- priate. Other truthful and nonmis- Subparts D–H [Reserved] leading statements, describing only the indications for use that have been es- Subpart I—Deodorant Drug tablished and listed in paragraph (b) of Products for Internal Use this section may also be used, as pro- vided in § 330.1(c)(2) of this chapter, SOURCE: 55 FR 19865, May 11, 1990, unless subject to the provisions of section 502 otherwise noted. of the Federal Food, Drug, and Cos- metic Act (the act) relating to mis- § 357.801 Scope. branding and the prohibition in section (a) An over-the-counter deodorant 301(d) of the act against the introduc- drug product for internal use in a form tion or delivery for introduction into suitable for oral administration is gen- interstate commerce of unapproved erally recognized as safe and effective new drugs in violation of section 505(a) and is not misbranded if it meets each of the act. condition in this subpart and each gen- (1) For products containing bismuth eral condition established in § 330.1 of subgallate identified in § 357.810(a). ‘‘An this chapter. aid to reduce odor from a colostomy or (b) References in this subpart to reg- ileostomy.’’ ulatory sections of the Code of Federal (2) For products containing Regulations are to chapter I of title 21 chlorophyllin copper complex identified in unless otherwise noted. § 357.810(b). (i) ‘‘An aid to reduce odor from a colostomy or ileostomy.’’ § 357.803 Definitions. (ii) ‘‘An aid to reduce fecal odor due As used in this subpart: to incontinence.’’ (a) Colostomy. An external operative (c) Warnings. The labeling of the opening of the colon. product contains the following warn- (b) Deodorant for internal use. An in- ings under the heading ‘‘Warnings’’: (1) gredient taken internally to reduce For products containing chlorophyllin odors arising from conditions such as copper complex identified in § 357.810(b). colostomies, ileostomies, or fecal in- (i) ‘‘If cramps or diarrhea occurs, re- continence. duce the dosage. If symptoms persist, (c) Ileostomy. An external operative consult your doctor.’’ opening from the ileum. (ii) The warning required by § 330.1(g) (d) Incontinence. An inability to re- of this chapter concerning overdose is tain urine or feces. not required on products containing chlorophyllin copper complex identi- § 357.810 Active ingredients for deo- fied in § 357.810(b). dorant drug products for internal (2) [Reserved] use. (d) Directions. The labeling of the The active ingredient of the product product contains the following infor- consists of either of the following when mation under the heading ‘‘Direc- used within the dosage limits estab- tions.’’ lished for each ingredient in § 357.850(d): (1) For products containing bismuth (a) Bismuth subgallate. subgallate identified in § 357.810(a). (b) Chlorophyllin copper complex. Adults and children 12 years of age and over: Oral dosage is 200 to 400 milli- § 357.850 Labeling of deodorant drug grams up to 4 times daily. Children products for internal use. under 12 years of age: consult a doctor. (a) Statement of identity. The labeling (2) For products containing of the product contains the established chlorophyllin copper complex identified in name of the drug, if any, and identifies § 357.810(b). Adults and children 12 years the product as a ‘‘deodorant for inter- of age and over: Oral dosage is 100 to nal use’’ or as a ‘‘colostomy or ileos- 200 milligrams daily in divided doses as tomy deodorant.’’ required. If odor is not controlled, take 314 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00324 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 358.110 up to an additional 100 milligrams 358.720 Permitted combinations of active in- daily in divided doses as required. The gredients. smallest effective dose should be used. 358.750 Labeling of drug products for the Do not exceed 300 milligrams daily. control of dandruff, seborrheic derma- titis, or psoriasis. Children under 12 years of age: consult 358.760 Labeling of permitted combinations a doctor. of active ingredients for the control of dandruff. PART 358—MISCELLANEOUS EXTER- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, NAL DRUG PRODUCTS FOR 360, 371. OVER-THE-COUNTER HUMAN SOURCE: 55 FR 33255, Aug. 14, 1990, unless USE otherwise noted. Subpart A [Reserved] Subpart A [Reserved] Subpart B—Wart Remover Drug Products Subpart B—Wart Remover Drug Sec. Products 358.101 Scope. 358.103 Definitions. § 358.101 Scope. 358.110 Wart remover active ingredients. 358.150 Labeling of wart remover drug prod- (a) An over-the-counter wart remover ucts. drug product in a form suitable for top- ical application is generally recognized Subpart C [Reserved] as safe and effective and is not mis- branded if it meets each of the condi- Subpart D—Ingrown Toenail Relief Drug tions in this subpart and each of the Products general conditions established in § 330.1 358.301 Scope. of this chapter. 358.303 Definitions. (b) References in this subpart to reg- 358.310 Ingrown toenail relief active ingre- ulatory sections of the Code of Federal dient. Regulations are to chapter I of title 21 358.350 Labeling of ingrown toenail relief unless otherwise noted. drug products. § 358.103 Definitions. Subpart E [Reserved] As used in this subpart: Subpart F—Corn and Callus Remover Drug (a) Wart remover drug product. A top- Products ical agent used for the removal of com- mon or plantar warts. 358.501 Scope. (b) Collodion-like vehicle. A solution 358.503 Definitions. containing pyroxylin (nitrocellulose) 358.510 Corn and callus remover active in- gredients. in an appropriate nonaqueous solvent 358.550 Labeling of corn and callus remover that leaves a transparent cohesive film drug products. when applied to the skin in a thin layer. Subpart G—Pediculicide Drug Products (c) Plaster vehicle. A fabric, plastic, or other suitable backing material in 358.601 Scope. which medication is usually incor- 358.603 Definition. 358.610 Pediculicide active ingredients. porated for topical application to the 358.650 Labeling of pediculicide drug prod- skin. ucts. § 358.110 Wart remover active ingredi- Subpart H—Drug Products for the Control ents. of Dandruff, Seborrheic Dermatitis, and The product consists of any of the Psoriasis following active ingredients within the specified concentration and in the dos- 358.701 Scope. 358.703 Definitions. age form established for each ingre- 358.710 Active ingredients for the control of dient. dandruff, seborrheic dermatitis, or psori- (a) Salicylic acid 12 to 40 percent in a asis. plaster vehicle. 315 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00325 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR.
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