{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 333 and title_number = 21 sorted by section_id", "rows": [["21:21:5.0.1.1.14.2.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.101 Scope.", "FDA", "", "", "", "(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in \u00a7 330.1.\n\n(b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.2.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.103 Definitions.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987, as amended at 64 FR 403, Jan. 5, 1999]", "As used in this subpart:\n\nFirst aid antibiotic.  An antibiotic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns."], ["21:21:5.0.1.1.14.2.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.110 First aid antibiotic active ingredients.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999]", "The product consists of any of the following active ingredients within the specified concentration established for each ingredient and in the specified dosage form:\n\n(a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base.\n\n(b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base.\n\n(c) Chlortetracycline hydrochloride ointment containing, in each gram, 30 milligrams of chlortetracycline hydrochloride in a suitable ointment base.\n\n(d) Neomycin sulfate ointment containing, in each gram, 3.5 milligrams of neomycin in a suitable water soluble or oleaginous ointment base.\n\n(e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams of neomycin in a suitable cream base.\n\n(f) Tetracycline hydrochloride ointment containing, in each gram, 30 milligrams of tetracycline hydrochloride in a suitable ointment base."], ["21:21:5.0.1.1.14.2.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.120 Permitted combinations of active ingredients.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987; 52 FR 48792, Dec. 24, 1987, as amended at 53 FR 18838, May 25, 1988; 55 FR 9722, Mar. 15, 1990; 55 FR 40381, Oct. 3, 1990; 55 FR 50172, Dec. 5, 1990; 64 FR 403, Jan. 5, 1999]", "The following combinations are permitted provided each active ingredient is present within the established concentration and in the specified dosage form, and the product is labeled in accordance with \u00a7 333.160.\n\n(a)  Combinations of antibiotic active ingredients.  (1) Bacitracin-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base.\n\n(2) Bacitracin-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 500 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B;\n\n(3) Bacitracin-polymyxin B sulfate topical aerosol containing, in each gram, 500 units of bacitracin and 5,000 units of polymyxin B in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(4) Bacitracin zinc-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base.\n\n(5) Bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 400 units of bacitracin, 3 milligrams of neomycin, and 8,000 units of polymyxin B; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(iii) 500 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(iv) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B;\n\n(6) Bacitracin zinc-polymyxin B sulfate ointment containing, in each gram, 500 units of bacitracin and 10,000 units of polymyxin B in a suitable ointment base.\n\n(7) Bacitracin zinc-polymyxin B sulfate topical aerosol containing, in each gram, 120 units of bacitracin and 2,350 units of polymyxin B in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(8) Bacitracin zinc-polymyxin B sulfate topical powder containing, in each gram, 500 units of bacitracin and 10,000 units of polymyxin B in a suitable base.\n\n(9) Neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, 3.5 milligrams of neomycin and 5,000 units of polymyxin B in a suitable water miscible base.\n\n(10) Neomycin sulfate-polymyxin B sulfate cream containing, in each gram, 3.5 milligrams of neomycin and 10,000 units of polymyxin B in a suitable vehicle.\n\n(11) Oxytetracycline hydrochloride-polymyxin B sulfate ointment containing, in each gram, 30 milligrams of oxytetracycline and 10,000 units of polymyxin B in a suitable ointment base.\n\n(12) Oxytetracycline hydrochloride-polymyxin B sulfate topical powder containing, in each gram, 30 milligrams of oxytetracycline and 10,000 units of polymyxin B with a suitable filler.\n\n(b)  Combinations of first aid antibiotic active ingredients and local anesthetic active ingredients.  (1) Bacitracin ointment containing, in each gram, 500 units of bacitracin and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable ointment base.\n\n(2) Bacitracin-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 500 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient.\n\n(3) Bacitracin-polymyxin B sulfate topical aerosol containing, in each gram, 500 units of bacitracin and 5,000 units of polymyxin B and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(4) Bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 400 units of bacitracin, 3 milligrams of neomycin, 8,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(iii) 500 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(iv) 500 units of bacitracin, 3.5 milligrams of neomycin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient;\n\n(5) Bacitracin zinc-polymyxin B sulfate ointment containing, in each gram, 500 units of bacitracin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable ointment base.\n\n(6) Neomycin sulfate-polymyxin B sulfate cream containing, in each gram, 3.5 milligrams of neomycin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable vehicle."], ["21:21:5.0.1.1.14.2.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.150 Labeling of first aid antibiotic drug products.", "FDA", "", "", "[52 FR 47332, Dec. 11, 1987, as amended at 61 FR 58472, Nov. 15, 1996]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as a \u201cfirst aid antibiotic.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the following: \u201cFirst aid to help\u201d [select one of the following: \u201cprevent,\u201d (\u201cdecrease\u201d (\u201cthe risk of\u201d or \u201cthe chance of\u201d)), (\u201creduce\u201d (\u201cthe risk of\u201d or \u201cthe chance of\u201d)), \u201cguard against,\u201d or \u201cprotect against\u201d] [select one of the following: \u201cinfection,\u201d \u201cbacterial contamination,\u201d or \u201cskin infection\u201d] \u201cin minor cuts, scrapes, and burns.\u201d Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in \u00a7 330.1(c)(2), subject to the provisions of section 502 of 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.\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1) \u201cFor external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.\u201d\n\n(2)  For products containing chlortetracycline hydrochloride or tetracycline hydrochloride. \u201cStop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by doctor.\u201d\n\n(3)  For any product containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, and/or polymyxin B sulfate.  \u201cStop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if you are allergic to any of the ingredients. Do not use longer than 1 week unless directed by a doctor.\u201d\n\n(d)  Directions.  The labeling of the product contains the following statements under the heading \u201cDirections\u201d: (1)  For ointment and cream products.  \u201cClean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(2)  For powder products.  \u201cClean the affected area. Apply a light dusting of the powder on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(3)  For aerosol products.  \u201cClean the affected area. Spray a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(e) The word \u201cdoctor\u201d may be substituted for the word \u201cphysician\u201d in any of the labeling statements in this subpart."], ["21:21:5.0.1.1.14.2.1.6", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.160 Labeling of permitted combinations of active ingredients.", "FDA", "", "", "", "Statements 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.\n\n(a)  Statement of identity.  For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs.\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the indication(s) for each ingredient in the combination, as established in the \u201cIndications\u201d sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in \u00a7 330.1(c)(2), subject to the provisions of section 502 of 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.\n\n(1)  For permitted combinations identified in \u00a7 333.120(a).  The indications in \u00a7 333.150 should be used.\n\n(2)  For permitted combinations identified in \u00a7 333.120(b).  In addition to the required indication identified in \u00a7 333.150, the labeling of the product may state, under the heading \u201cIndications,\u201d the following additional indication: \u201cFirst aid for the temporary relief of\u201d (select one of the following: \u201cpain,\u201d \u201cdiscomfort,\u201d \u201cpain or discomfort\u201d or \u201cpain and itching\u201d) \u201cin minor cuts, scrapes, and burns.\u201d\n\n(c)  Warnings.  The labeling of the product states, under the heading \u201cWarnings,\u201d the warning(s) for each ingredient in the combination, as established in the warnings sections of the applicable OTC drug monographs.\n\n(d)  Directions.  The labeling of the product states, under the heading \u201cDirections,\u201d directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs. When the time intervals or age limitations for administrations of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph."], ["21:21:5.0.1.1.14.3.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.201 Scope.", "FDA", "", "", "", "(a) An over-the-counter antifungal drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in \u00a7 330.1 of this chapter.\n\n(b) Reference in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.3.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.203 Definitions.", "FDA", "", "", "", "As used in this subpart:\n\n(a)  Antifungal.  A drug which inhibits the growth and reproduction of fungal cells and decreases the number of fungi present.\n\n(b)  Athlete's foot.  An infection of the feet caused by certain dermatophytic fungi.\n\n(c)  Dermatophyte.  A fungus that invades and lives upon the skin or in the hair or nails.\n\n(d)  Fungus.  Any of a large division of plants, including dermatophytes, yeasts, and molds, characterized by a simple cell structure and the absence of chlorophyll.\n\n(e)  Jock itch.  A chronic and recurrent infection caused by certain dermatophytic fungi; affects the upper, inner thighs and sometimes extends to the groin and the pubic area; the condition most frequently occurs in men, but may also occur in women.\n\n(f)  Ringworm.  A skin infection caused by certain dermatophytic fungi."], ["21:21:5.0.1.1.14.3.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.210 Antifungal active ingredients.", "FDA", "", "", "[58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002]", "The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient:\n\n(a) Clioquinol 3 percent.\n\n(b) Haloprogin 1 percent.\n\n(c) Miconazole nitrate 2 percent.\n\n(d) Povidone-iodine 10 percent.\n\n(e) Tolnaftate 1 percent.\n\n(f) Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent.\n\n(g) Clotrimazole 1 percent."], ["21:21:5.0.1.1.14.3.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.250 Labeling of antifungal drug products.", "FDA", "", "", "[58 FR 49898, Sept. 23, 1993, as amended at 65 FR 52305, Aug. 29, 2000]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as an \u201cantifungal.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the phrase listed in paragraph (b)(1)(i) of this section and may contain the additional phrase listed in paragraph (b)(1)(ii) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in \u00a7 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.\n\n(1)  For products containing any ingredient identified in \u00a7 333.210 labeled for the treatment of athlete's foot, jock itch, and ringworm.  (i) (Select one of the following: \u201cTreats,\u201d \u201cFor the treatment of,\u201d \u201cFor effective treatment of,\u201d \u201cCures,\u201d \u201cFor the cure of,\u201d \u201cClears up,\u201d or \u201cProven clinically effective in the treatment of\u201d) \u201cmost\u201d (select one condition from any one or more of the following groups of conditions:\n\n(A) \u201cAthlete's foot,\u201d athlete's foot (dermatophytosis),\u201d \u201cathlete's foot (tinea pedis),\u201d or \u201ctinea pedis (athlete's foot)\u201d;\n\n(B) \u201cJock itch,\u201d \u201cjock itch (tinea cruris),\u201d or \u201ctinea cruris (jock itch)\u201d; or\n\n(C) \u201cRingworm,\u201d \u201cringworm (tinea corporis),\u201d or \u201ctinea corporis (ringworm).\u201d)\n\n(ii) In addition to the information identified in paragraph (b)(1)(i) of this section, the labeling of the product may contain the following statement: (Select one of the following: \u201cRelieves,\u201d \u201cFor relief of,\u201d \u201cFor effective relief of,\u201d or \u201cSoothes,\u201d) (select one or more of the following: \u201cItching,\u201d \u201cscaling,\u201d \u201ccracking,\u201d \u201cburning,\u201d \u201credness,\u201d \u201csoreness,\u201d \u201cirritation,\u201d \u201cdiscomfort,\u201d \u201cchafing associated with jock itch,\u201d \u201citchy, scaly skin between the toes,\u201d or \u201citching, burning feet\u201d).\n\n(2)  For products containing the ingredient identified in \u00a7 333.210(e) labeled for the prevention of athlete's foot.  (i) (Select one of the following: \u201cClinically proven to prevent,\u201d \u201cPrevents,\u201d \u201cProven effective in the prevention of,\u201d \u201cHelps prevent,\u201d \u201cFor the prevention of,\u201d \u201cFor the prophylaxis (prevention) of,\u201d \u201cGuards against,\u201d or \u201cPrevents the recurrence of\u201d) \u201cmost\u201d (select one of the following: \u201cAthlete's foot,\u201d \u201cathlete's foot (dermatophytosis),\u201d \u201cathlete's foot (tinea pedis),\u201d or \u201ctinea pedis (athlete's foot)\u201d) \u201cwith daily use.\u201d\n\n(ii) In addition to the information identified in paragraph (b)(2)(i) of this section, the labeling of the product may contain the following statement: \u201cClears up most athlete's foot infection and with daily use helps keep it from coming back.\u201d\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1)  For products containing any ingredient identified in \u00a7 330.210.  (i) \u201cDo not use on children under 2 years of age unless directed by a doctor.\u201d\n\n(ii) \u201cFor external use only.\u201d\n\n(iii) \u201cAvoid contact with the eyes.\u201d\n\n(2)  For products labeled according to paragraph (b)(1) of this section for the treatment of athlete's foot and ringworm.  \u201cIf irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.\u201d\n\n(3)  For products labeled according to paragraph (b)(1) of this section for the treatment of jock itch.  \u201cIf irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.\u201d\n\n(4)  For products labeled according to paragraph (b)(2) of this section for the prevention of athlete's foot.  \u201cIf irritation occurs, discontinue use and consult a doctor.\u201d\n\n(5)  For products containing the ingredient identified in \u00a7 333.210(a) labeled according to paragraph (b)(1) of this section.  The following statements must appear in boldface type as the first warnings under the \u201cWarnings\u201d heading. (i) \u201cDo not use on children under 2 years of age.\u201d (This warning is to be used in place of the warning in paragraph (c)(1)(i) of this section.)\n\n(ii) \u201cDo not use for diaper rash.\u201d\n\n(d)  Directions.  The labeling of the product contains the following statements under the heading \u201cDirections\u201d:\n\n(1)  For products labeled according to paragraph (b)(1) of this section for the treatment of athlete's foot, jock itch, and ringworm.  [Select one of the following: \u201cClean\u201d or \u201cWash\u201d] \u201cthe affected area and dry thoroughly. Apply\u201d (the word \u201cspray\u201d may be used to replace the word \u201capply\u201d for aerosol products) \u201ca thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.\u201d\n\n(2)  For products labeled according to paragraph (b)(2) of this section for the prevention of athlete's foot.  \u201cTo prevent athlete's foot,\u201d (select one of the following: \u201cclean\u201d or \u201cwash\u201d) \u201cthe feet and dry thoroughly. Apply\u201d (the word \u201cspray\u201d may be used to replace the word \u201capply\u201d for aerosol products) \u201ca thin layer of the product to the feet once or twice daily (morning and/or night). Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.\u201d\n\n(e) The word \u201cphysician\u201d may be substituted for the word \u201cdoctor\u201d in any of the labeling statements in this section."], ["21:21:5.0.1.1.14.3.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.280 Professional labeling.", "FDA", "", "", "", "The labeling provided to health professionals (but not to the general public) may contain the following additional indication:\n\n(a)  For products containing haloprogin or miconazole nitrate identified in \u00a7 333.210 (a) and (c).  \u201cFor the treatment of superficial skin infections caused by yeast ( Candida albicans ).\u201d\n\n(b) [Reserved]"], ["21:21:5.0.1.1.14.4.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.301 Scope.", "FDA", "", "", "", "(a) An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in \u00a7 330.1 of this chapter.\n\n(b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.4.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.303 Definitions.", "FDA", "", "", "", "As used in this subpart:\n\n(a)  Acne.  A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes.\n\n(b)  Acne blemish.  A flaw in the skin resulting from acne.\n\n(c)  Acne drug product.  A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads.\n\n(d)  Acne pimple.  A small, prominent, inflamed elevation of the skin resulting from acne.\n\n(e)  Blackhead.  A condition of the skin that occurs in acne and is characterized by a black tip.\n\n(f)  Whitehead.  A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin."], ["21:21:5.0.1.1.14.4.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.310 Acne active ingredients.", "FDA", "", "", "[75 FR 9776, Mar. 4, 2010]", "The active ingredient of the product consists of any of the following:\n\n(a) Benzoyl peroxide, 2.5 to 10 percent.\n\n(b) Resorcinol, 2 percent, when combined with sulfur in accordance with \u00a7 333.320(a).\n\n(c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with \u00a7 333.320(b).\n\n(d) Salicylic acid, 0.5 to 2 percent.\n\n(e) Sulfur, 3 to 10 percent.\n\n(f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with \u00a7 333.320."], ["21:21:5.0.1.1.14.4.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.320 Permitted combinations of active ingredients.", "FDA", "", "", "[75 FR 9776, Mar. 4, 2010]", "(a) Resorcinol identified in \u00a7 333.310(b) may be combined with sulfur identified in \u00a7 333.310(f).\n\n(b) Resorcinol monoacetate identified in \u00a7 333.310(c) may be combined with sulfur identified in \u00a7 333.310(f)."], ["21:21:5.0.1.1.14.4.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.350 Labeling of acne drug products.", "FDA", "", "", "[56 FR 41019, Aug. 16, 1991, as amended at 75 FR 9776, Mar. 4, 2010]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as an \u201cacne medication,\u201d \u201cacne treatment,\u201d \u201cacne medication\u201d (insert dosage form, e.g., \u201ccream,\u201d \u201cgel,\u201d \u201clotion,\u201d or \u201cointment\u201d), or \u201cacne treatment\u201d (insert dosage form, e.g., \u201ccream,\u201d \u201cgel,\u201d \u201clotion,\u201d or \u201cointment\u201d).\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the phrase listed in paragraph (b)(1) of this section and may contain any of the additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in \u00a7 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.\n\n(1) \u201cFor the\u201d (select one of the following: \u201cmanagement\u201d or \u201ctreatment\u201d) \u201cof acne.\u201d\n\n(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any one or more of the following statements:\n\n(i) (Select one of the following: \u201cClears,\u201d \u201cClears up,\u201d \u201cClears up most,\u201d \u201cDries,\u201d \u201cDries up,\u201d \u201cDries and clears,\u201d \u201cHelps clear,\u201d \u201cHelps clear up,\u201d \u201cReduces the number of,\u201d or \u201cReduces the severity of\u201d) (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d) which may be followed by \u201cand allows skin to heal.\u201d\n\n(ii) \u201cPenetrates pores to\u201d (select one of the following: \u201celiminate most,\u201d \u201ccontrol,\u201d \u201cclear most,\u201d or \u201creduce the number of\u201d) (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(iii) \u201cHelps keep skin clear of new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(iv) \u201cHelps prevent new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d) which may be followed by \u201cfrom forming.\u201d\n\n(v) \u201cHelps prevent the development of new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1)  For products containing any ingredients identified in \u00a7 330.310.\n\n(i) The labeling states \u201cFor external use only.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.\u201d\n\n(2)  For products containing sulfur identified in \u00a7 333.310(e) and (f).\n\n(i) The labeling states \u201cDo not use on [bullet] broken skin [bullet] large areas of the skin.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] apply only to areas with acne.\u201d\n\n(3)  For products containing any combination identified in \u00a7 333.320.  (i) The labeling states \u201cWhen using this product [bullet] rinse right away with water if it gets in eyes.\u201d\n\n(ii) The labeling states \u201cStop use and ask a doctor [bullet] if skin irritation occurs or gets worse.\u201d\n\n(4)  For products containing benzoyl peroxide identified in \u00a7 333.310(a).\n\n(i) The labeling states \u201cDo not use if you [bullet] have very sensitive skin [bullet] are sensitive to benzoyl peroxide.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] avoid unnecessary sun exposure and use a sunscreen [bullet] avoid contact with the eyes, lips, and mouth [bullet] avoid contact with hair and dyed fabrics, which may be bleached by this product [bullet] skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.\u201d\n\n(iii) The labeling states \u201cStop use and ask a doctor if [bullet] irritation becomes severe.\u201d\n\n(d)  Directions.  The labeling of the product contains the following information under the heading \u201cDirections\u201d:\n\n(1)  For products applied containing any ingredient identified in \u00a7 333.310.  The labeling states \u201c[bullet] clean the skin thoroughly before applying this product [bullet] cover the entire affected area with a thin layer one to three times daily [bullet] because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor [bullet] if bothersome dryness or peeling occurs, reduce application to once a day or every other day.\u201d\n\n(2)  For products applied and left on the skin containing benzoyl peroxide identified in \u00a7 333.310(a).\n\n(i) The labeling states the directions in paragraph (d)(1) of this section.\n\n(ii) The labeling states \u201c[bullet] if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.\u201d\n\n(3)  For products applied and removed from the skin containing any ingredient identified in \u00a7 333.310.  Products, such as soaps and masks, may be applied and removed and should include appropriate directions. All products containing benzoyl peroxide should include the directions in paragraph (d)(2)(ii) of this section.\n\n(4)  Optional directions.  In addition to the required directions in paragraphs (d)(1) and (d)(2) of this section, the product may contain the following optional labeling: \u201c Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated (select one of the following: \u2018elsewhere on this label,\u2019 \u2018above,\u2019 or \u2018below\u2019).\u201d"]], "truncated": false, "filtered_table_rows_count": 16, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, title_name, chapter, subchapter, part_number, part_name, subpart, subpart_name, section_number, section_heading, agency, authority, source_citation, amendment_citations, full_text from cfr_sections where \"part_number\" = :p0 and \"title_number\" = :p1 order by section_id limit 101", "params": {"p0": "333", "p1": "21"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333&title_number=21", "results": [{"value": 21, "label": 21, "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333", "selected": true}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333&title_number=21", "results": [{"value": "FDA", "label": "FDA", "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=21&agency=FDA", "selected": false}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333&title_number=21", "results": [{"value": "333", "label": "333", "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?title_number=21", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=21&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=21&_facet=subpart_name"}, {"name": "amendment_citations", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=21&_facet=amendment_citations"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 341.1802570335567, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}