Label: GLYTONE ACNE TREATMENT- salicylic acid lotion

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

Drug Label Information

Updated January 19, 2024

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  • Drug Facts

  • Active Ingredients

    Salicylic Acid 1 %

  • Purpose

    Acne Treatment

  • 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

    For external use only.

    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 contact with the eyes. If eye contact occurs, flush thoroughly with water.

    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 medication.
    • Cover the affected area(s) with a thin layer one to three times daily, or as directed by your physician.
    • 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.
  • Other Information

     Store at room temperature of 68-77° F (20-25° C).

  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethoxydiglycol, Propylene Glycol, Glyceryl Laurate, PEG-100 Stearate, Cyclopentasiloxane, Cetearyl Glucoside, Behenyl Alcohol, Bisabolol, Carnosine, Hydrogenated Lecithin, Oryza Sativa (Rice) Bran Extract, Xanthan Gum, Sodium Hydroxide, Polysilicone-11, Disodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Isobutylparaben, Phenoxyethanol

  • Principal Display Panel

    Acne Treatment Lotion​​GLYTONE

    Acne Treatment Lotion

    1.0% Salicylic Acid

    NON-IRRITATING FORMULA

    NET WT. 56.7 g / 2 OZ.

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE TREATMENT 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-709
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    RICE BRAN (UNII: R60QEP13IC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-709-011 in 1 CARTON10/20/2017
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/20/201706/16/2024
    Labeler - Pierre Fabre USA Inc. (117196928)
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