Label: ACNE WASH OIL-FREE- 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 September 30, 2013

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  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne treatment

  • Keep Out of Reach of Children

  • Uses

    for the treatment of acne

  • Warnings

    For external use only.

    Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, If contact occurs, flush thoroughly with water.

  • Directions

    Cleanse twice daily

    Gently massage onto wet face, add water and work into a lather

    Rinse thoroughly

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    CareOne acne wash oil-free

    Acne treatment with Salicylic Acid

    Dermatologically tested

    *Compare to Neutrogena© Oil-Free Acne Wash ingredients

    6 FL OZ (177 mL)

    3D530 D4 F1

    *This product is not manufactured or distributed by Neutrogena©

    DISTRIBUTED BY FOODHOLD, U.S.A., LLC
    LANDOVER, MD 20785 1-877-846-9949
    © 2013 S&S Brands, LLC
    MADE IN ISRAEL

    Quality guaranteed or your money back.

    Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    ACNE WASH OIL-FREE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-530
    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
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-530-11177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/15/2013
    Labeler - American Sales Company (809183973)
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