Label: ACNE WASH- salicylic acid liquid

  • 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 March 19, 2020

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  • Active Ingredients

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    for the treatment of acne.

  • Warnings

    For external use only

  • WHEN USING

    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

    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, sodium chloride, linoleamidopropyl PG-dimonium chloride phosphate, polysorbate 20, anthemis nobilis flower extract, citrus grandis (grapefruit) fruit extract, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, C12-15 alkyl lactate, cocamidopropyl PG-dimononium chloride phosphate, polyquaternium-7, ascorbyl palmitate, propylene glycol, sodium benzotriazolyl butylphenol sulfonate, PEG-120 methyl glucose dioleate, PEG-80 sorbitan laurate, disodium EDTA, benzalkonium chloride, fragrance, red 40, Ext. Violet 2

  • PRINCIPAL DISPLAY PANEL

    FACE VALUES OIL-FREE SENSITIVE SKIN DEEP CLEANSING TONER STEP 2

    8 FL OZ (240mL)

    NDC 63940-054-87

    LabelFront

    LabelBack

  • INGREDIENTS AND APPEARANCE
    ACNE WASH 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-054
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-054-87240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/29/2010
    Labeler - Harmon Stores Inc. (804085293)
    Registrant - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of the Earth, Inc.008193513manufacture(63940-054)