Label: OIL-FREE ACNE WASH- salicylic acid solution

  • 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 November 12, 2013

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  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Indications

    • 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.

  • Keep Out of Reach of Children.

    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

    • Clean 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, benzalkonium chloride, disodium EDTA, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, yellow 5, red 40

  • Package/Label Principal Display Panel

    Harmon® FaceValuesTM
    Oil-Free Acne Wash
    Acne Treatment     with Salicylic Acid

    Gentle Cleanser helps treat and prevent breakouts

    Dermatologist tested

    9.1 Fl Oz (269 mL)

    Compare Ours to the Active Ingredient in Neutrogena® Oil-Free Acne Wash*

    Distributed by

    Harmon Stores, Inc.
    650 Liberty Ave.
    Union, NJ 07083 USA
    ©Harmon Stores, Inc.

    Visit us at:
    www.facevalues.com

    Manufactured in Israel

    Harmon Satisfaction Guaranteed or Your Money Back

    3D536 B1 B1

    *This product is not manufactured or distributed by Neutrogena® owner of the Oil-Free Acne Wash.

    Acne Wash Label

    Label

  • INGREDIENTS AND APPEARANCE
    OIL-FREE ACNE WASH 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-536
    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:63940-536-11269 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/15/2013
    Labeler - Harmon Stores Inc (804085293)
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