Label: ACNE CLEANSING- salicylic acid gel

  • 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 October 26, 2021

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  • Drug Facts

  • Active Ingredient

    Salicylic Acid 1%

    Purpose

    Acne Treatment

  • Use

    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

    • Cleanse skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer and rinse thoroughly 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 directed by a doctor
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive Ingredients

    Disodium Cocoamphodiacetate, Water, Sodium Lauroyl Lactylate, Decyl Glucoside, Salix Nigra (Willow) Bark Extract, Phenoxyethanol, Melaleuca alternifolia (Tea Tree) Leaf Oil, Ethylhexylglycerin, Ascorbyl Palmitate, Glycerin, Camellia Sinensis (Green Tea) Leaf Extract

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72503-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72503-000-00120 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2018
    Labeler - KitavaMD, Inc (074709983)
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