Label: ACNE SOLUTIONS OIL CONTROL CLEANSING MASK ACNE MEDICATION ALL SKIN TYPES- salicylic acid cream

  • NDC Code(s): 49527-713-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Salicylic acid 1.0%Acne treatment
  • Use

    for the treatment of acne

  • Warnings

    For external use only.

    When using this product

    • using other topical acne drugs at the same time or right after 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.

  • Directions

    • apply evenly to clean skin, avoiding eye area
    • leave on 5 minutes
    • rinse off thoroughly with warm water
    • If bothersome dryness or peeling occurs, reduce application to every other day
  • Inactive ingredients

    water\aqua\eau , kaolin , butylene glycol , magnesium aluminum silicate , sodium lauroyl sarcosinate , glyceryl stearate , peg-100 stearate , gentiana lutea (gentian) root extract , laminaria saccharina extract , sucrose , algae extract , aloe barbadensis leaf extract , acetyl glucosamine , inulin , 1,2-hexanediol , caprylyl glycol , xanthan gum , disodium edta , hexylene glycol , chlorphenesin , phenoxyethanol , titanium dioxide (ci 77891) <iln51366>

  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

    acne

    CLINIQUE

    acne solutions

    oil-control

    cleansing mask

    SALICYLIC ACID

    ACNE MEDICATION

    ALL SKIN TYPES

    3.4 FL.OZ.LIQ./100 ml ℮

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS OIL CONTROL CLEANSING MASK  ACNE MEDICATION ALL SKIN TYPES
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-713
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    SUCROSE (UNII: C151H8M554)  
    AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
    ALOE (UNII: V5VD430YW9)  
    DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)  
    INULIN (UNII: JOS53KRJ01)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-713-011 in 1 CARTON12/10/202005/10/2026
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/10/202005/10/2026
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture(49527-713) , pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-713) , pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-713) , pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-713) , label(49527-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(49527-713) , label(49527-713)
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