Label: ACNE DEFENSE FOAMING CLEANSER MERLE NORMAN- salicylic acid liquid

  • NDC Code(s): 57627-200-01
  • 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 (medicinal) 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 time or immediately followign the use of this product may increase dryness or irritation of the skin. If this occurrs, only one medication should be used unless directed by a doctor

  • WARNINGS

    ​Warning

    • ​For external use only
    • ​Keep out of eyes. Rinse with water to remove
  • DOSAGE & ADMINISTRATION

    Massage product into lather and apply onto damp face, avoiding eye area. Rinse thoroughly. Wash 2 to 3 times daily or as directed by a doctor. If bothersome drynesss or peeling occurs, reduce application to once a day or every other day. 

  • INACTIVE INGREDIENT

    Aqua/Water/Eau, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Disodium Cocoamphodiacetate, Acacia Concinna Fruit Extract, Aloe Barbedensis Leaf Juice, Gypsophila Pariculata Root Extract, Chrysanthemum Parthenium (Feverfew) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sea Whip Extract, Chamomila Recutita (Matricaria) Flower Extract, Elettaria Cadamomum Seed Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Eugenia Caryophyllus (Clove) Flower Extract, Gardenia Aitensis Flower Extract, Hibiscus Abelmoschus Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Vanilla Planifolia Fruit Extract, Hedychium Spicatum Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Plumeria Rubra Flower Extract, Ascorbyl Palmitate, Retinyl Plamitate, Tocopheryl Acetate, Cocamidopropyl PG-Dimonium Chloride Phosphate, PEG-9 Dimethicone, Phospholipids, Glucose, Lactic Acid, Caprylic/Capric Triglyceride, Panthenol, Balanites Aegyptiace Fruit Extract, Bisabolo, Ethoxydiglycol, Propylene Glycol, Xanthan Gum, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    ACNE DEFENSE FOAMING CLEANSER

    merle norman

    LIQUID

    135 mL e  4.5 FL. OZ.

    Label

  • INGREDIENTS AND APPEARANCE
    ACNE DEFENSE FOAMING CLEANSER  MERLE NORMAN
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-200
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ACACIA CONCINNA FRUIT (UNII: S9108H4YLE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GYPSOPHILA PANICULATA ROOT (UNII: RH6WI83A9M)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    ORANGE (UNII: 5EVU04N5QU)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CARDAMOM (UNII: 8BC4CUT4JL)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CLOVE (UNII: K48IKT5321)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
    APRICOT (UNII: 269CJD5GZ9)  
    APPLE (UNII: B423VGH5S9)  
    VANILLA (UNII: Q74T35078H)  
    HEDYCHIUM SPICATUM ROOT (UNII: 1831B6Y350)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-9 DIMETHICONE (UNII: 9OZ27X065D)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57627-200-01135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/13/2017
    Labeler - Merle Norman Cosmetics, Inc (008479388)
    Registrant - Merle Norman Cosmetics, Inc (008479388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merle Norman Cosmetics, Inc008479388manufacture(57627-200)
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