Label: ACNE WASH- salicylic acid liquid

  • NDC Code(s): 63940-052-54, 63940-052-61
  • Packager: Harmon Stores Inc.
  • 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 July 14, 2021

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  • Active Ingredients

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    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. • avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Keep out of reach of children.

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

  • Directions

    • 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 as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other information

    • may stain some fabrics
  • Inactive Ingredients

    water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, chamomilla recutita (matricaria) flower extract, cocamidopropyl PG-dimonium chloride phosphate, propylene glycol, aloe barbadensis leaf juice, anthemis nobilis flower extract, C12-15 alkyl lactate, PEG-80 sorbitan laurate, disodium EDTA, benzalkonium chloride, fragrance, yellow 5, red 40.

  • PRINCIPAL DISPLAY PANEL

    42713EF

    42715E2F2

  • INGREDIENTS AND APPEARANCE
    ACNE WASH 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-052
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-052-54269 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/02/2015
    2NDC:63940-052-6159 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/02/2015
    Labeler - Harmon Stores Inc. (804085293)
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