Label: GLYTONE ACNE BPO TREATMENT GEL- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Drug Facts

  • Purpose

    Acne Treatment

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Use

    For the treatment of Acne.

    Dries and clears acne blemishes and allows skin to heal.

    Penetrates pores to eliminate most acne blemishes, blackheads and whiteheads.

    Helps prevent the development of new acne blemishes, blackheads and whiteheads.

  • Warnings

    For external use only.

    Do not use if you

    have very sensitive skin

    are sensitive to benzoyl peroxide

    When using this product

    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.

    avoid unnecessary sun exposure and use a sunscreen.

    avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

    avoid contact with hair and dyed fabrics, which may be bleached by this product.

    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.

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Cleanse the skin thoroughly before applying product.

    Cover the affected area(s) with a thin layer one to three times daily.

    Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by your physician.

    If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

  • Other Information

    Store at room temperature of 68-77 F (22-25 C).

  • Inactive Ingredients

    Water (AQUA), PROPANEDIOL, DIMETHYL ISOSORBIDE, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, ACRYLAMIDE/SODIUM ACRYLOYL-DIMETHYLTAURATE COPOLYMER, ISOHEXADECANE, HYDROXYACE-TOPHENONE, POLYSORBATE 80, POLYGLYCERYL-2 ISOSTEARATE, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, SODIUM CITRATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CITRIC ACID, DIETHYLHEXYL SODIUM SULFOSUCCINATE, CARBOMER, SODIUM HYDROXIDE, ETHYLHEXYL-GLYCERIN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, DIMETHICONE, ARCTIUM LAPPA ROOT EXTRACT, PHENOXYETHANOL, OLEANOLIC ACID, PEG-40 STEARATE, SILICA, SORBITAN STEARATE, TOCOPHEROL

  • Principal Display Panel - 60 mL

    GLYTONE

    Acne BPO Treatment Gel

    Acne Therapy

    5% Micronized Benzoyl Peroxide

    Non-Irritating Formula

    60 mL/ 2 FL. OZ.

    Acne BPO Gel

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE BPO TREATMENT GEL 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-732
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-732-011 in 1 CARTON09/01/202101/31/2025
    11 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/202101/31/2025
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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