Label: ACNE CLEANSING- salicylic acid gel

  • NDC Code(s): 49527-045-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • treats acne
    • clears acne blemishes
    • helps prevent development of new acne blemishes
  • Warnings

    For external use only

    When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands and work into a lather
    • Add water to increase lather
    • Massage gently over wet skin, avoiding eye area
    • Rinse
    • Use A.M. and P.M.
    • If bothersome drying or peeling occurs, reduce usage to every other day
    • Follow with Acne Solutions Clarifying Lotion
  • Inactive ingredients

    water\aqua\eau [] glycerin [] sodium laureth sulfate [] sodium chloride [] lauramidopropyl betaine [] butylene glycol [] sucrose [] gentiana lutea (gentian) root extract [] laminaria saccharina extract [] caffeine [] sodium hyaluronate [] acetyl glucosamine [] peg-120 methyl glucose dioleate [] benzophenone-4 [] sodium hydroxide [] tetrasodium edta [] disodium edta [] bht [] phenoxyethanol [] blue 1 (ci 42090) <iln50388>

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 125 mL Tube Carton

    Principal Display Panel


    CLINIQUE

    acne solutions

    cleansing gel

    SALICYLIC ACID

    ACNE MEDICATION

    ALL SKIN TYPES

    4.2 FL.OZ.LIQ./125 ml e

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SUCROSE (UNII: C151H8M554)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    CAFFEINE (UNII: 3G6A5W338E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-045-011 in 1 CARTON10/01/2014
    1125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/01/2014
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-045) , pack(49527-045) , label(49527-045)
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