Label: OIL FREE ACNE WASH- salicylic acid 2.00% cream

  • 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 25, 2018

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  • Active ingredient                    Purpose

    Salicylic acid 2%..................... Acne treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use for the treatment of acne

  • WarningsFor external use only

    When using  other topical acne medications at the same time or immediately following use of this product. This 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.

  • DOSAGE & ADMINISTRATION

    Directions • wet face • apply to hands and work into a lather • massage face gently • rinse thoroughly and pat dry • cleanse twice a day.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cetyl Alcohol, Stearyl Alcohol, Di-C12-15 Alkyl Fumarate, Coco-Glucoside, Coconut Alcohol, Sodium Methyl Cocoyl Taurate, DEA-Cetyl Phosphate, Matriciaria (Chamomilla Recutita) Flower Extract, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Hydroxypropyl Methylcellulose, Potato (Solanum Tuberosum) Starch, Propylene Glycol, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OIL FREE ACNE WASH 
    salicylic acid 2.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-743
    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
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Di-C12-15 Alkyl Fumarate (UNII: A1CB3Z898P)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Coconut Alcohol (UNII: 13F4MW8Y9K)  
    Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-743-05198 mL in 1 TUBE; Type 0: Not a Combination Product11/17/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/17/2011
    Labeler - Topco (006935977)
    Registrant - Product Quest (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135manufacture(36800-743) , label(36800-743)
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