Label: ACNE DEFENSE SPOT TREATMENT MERLE NORMAN- salicylic acid gel

  • NDC Code(s): 57627-201-01, 57627-201-02
  • Packager: Merle Norman Cosmetics, 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 January 27, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient:                             Purpose

    Salicylic Acid 2.0%                             Acne Treatment

  • PURPOSE

    For the treatment of Acne

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Using other topical acne medication at the same tim or immediately following the 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

  • WARNINGS

    • For external use only
  • DOSAGE & ADMINISTRATION

    Cleanse skin thoroughly before applying. Cover the entire affected area with a thing layer 1 to 3 times daily or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    SD Alcohol 40-B, Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Polyacrylate Crosspolymer 6, Laminaria Saccarina Extract, Thermus Thermophillus Ferment, Opuntia Ficus-Indica Stem Extract, Sea Whip Extract, Bisabolol, Glycerin, Pentylene Glycol, Butylene Glycol, Propylene Glycol, Aminomethyl Propanol, 4-t-Butylcyclohexanol, Hydroxyethylcellulose, Hydroxymethoxyphenyl Decanone, Benzalkonium Chloride

  • PRINCIPAL DISPLAY PANEL

    ACNE DEFENSE

    SPOT TREATMENT

    ACNE TREATMENT GEL   

    merle norman

    14g e

    NET WT. .50 OZ.

    label

    carton

  • INGREDIENTS AND APPEARANCE
    ACNE DEFENSE SPOT TREATMENT  MERLE NORMAN
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57627-201-021 in 1 CARTON07/14/2017
    1NDC:57627-201-0114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/14/2017
    Labeler - Merle Norman Cosmetics, Inc (008479388)
    Registrant - Merle Norman Cosmetics, Inc (008479388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merle Norman Cosmetics, Inc008479388manufacture(57627-201)
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