Label: MEDICATED GEL CLEANSER -2% SALICYLIC ACID- salicylic acid soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient: Salicylic Acid (2%)

  • INACTIVE INGREDIENT

    Other Ingredients: Cocamidopropyl Hydrosultaine (Scherctaine SCAB), Disodium EDTA, D-Panthenol, Deionized Water, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Eucalyptus Oil, Sage Extract, Witch Hazel, Willow Bark, Glycerin, Isoceteth-20, Phenoxyethanol, Pinus Sylvestre, Potassium Sorbate, Sodium Lauryl Sulfoacetate, Water, Xanthan Gum

  • DOSAGE & ADMINISTRATION

    Recommended Use: Use daily both morning and night. Cleanse facial and neck area by massaging a liberal amount onto damp skin using upward circular motions. Rinse thoroughly with warm water.

  • INDICATIONS & USAGE

    To cleanse skin and prevent acne

  • WARNINGS

    WARNING: For External Use Only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center.

  • WHEN USING

    When using this product: using other acne medications at the same time may cause excessive dryness or irritation. Do not use in or near eyes, lips and mouth.

  • PURPOSE

    Purpose: acne medication

  • PRINCIPAL DISPLAY PANEL

    Medicated Gel Cleanser

  • INGREDIENTS AND APPEARANCE
    MEDICATED GEL CLEANSER -2% SALICYLIC ACID 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    WILLOW BARK (UNII: S883J9JDYX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-008-4545 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-008-77228 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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