Label: ACNE TREATMENT GEL- salicylic acid gel

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

Drug Label Information

Updated December 28, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic acid 2%

    Purpose

    Acne treatment

  • Use

    For the treatment of acne

  • Warnings

    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.

    Keep out of reach of children.

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

  • Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected area 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 or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive ingredients

    Water (aqua), pentylene glycol, biberry (Vaccinium myrtilus) fruit extract, xanthan gum, sodium hydroxide, sugarcane (Saccharum officinarum) extract, glycerin, saccharide isomerate, orange (Citrus sinensis) fruit extract, lemon (Citrus x limon) fruit extract, sugar maple (Acer saccharum) extract, hydrolyzed algin, citric acid, sodium citrate, zinc sulfate.

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31720-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MYRICA CERIFERA FRUIT (UNII: 2VZ27D14UH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31720-301-081 in 1 BOX12/05/2022
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/05/2022
    Labeler - S+ (572406531)
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