Label: CLEARCALM NON-DRYING ACNE TREATMENT- salicylic acid gel

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

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

    Purpose

    AcneTreatment

  • 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), Alcohol Denat.,Glycerin, Xanthan Gum, Maritime Pine Bark Extract, Caprylyl/Capryl Glucoside, Willow Bark Extract, Xylitylglucoside, Anhydroxylitol, Sodium Benzoate, Xylitol, Propanediol, Sandalwood Wood Oil, Potassium Sorbate, Sodium Cocoyl Glutamate, Glucose, Citric Acid, Glyceryl Caprylate, Polyglyceryl-6 Oleate, Thyme Leaf Oil, Chlorella Extract, Sodium Surfactin, Lactic Acid, Sodium Lactate, Farnesol

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CLEARCALM NON-DRYING ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51417-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    WILLOW BARK (UNII: S883J9JDYX)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51417-0005-11 in 1 BOX06/01/2019
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/01/2019
    Labeler - Ren Ltd. (385613831)
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