Label: ACNE SOLUTIONS CLINICAL ADVANCED CLEARING GEL- salicylic acid gel

  • NDC Code(s): 49527-221-01, 49527-221-02, 49527-221-03
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 3, 2025

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  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne Treatment

  • Use

    for the treatment of acne

  • 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 swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • cleanse skin thoroughly before applying
    • cover the entire affected area with a thin layer one to two times daily, avoid eye area
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive Ingredients

    alcohol denat.,hamamelis virginiana (witch hazel) water,acrylates/c10-30 alkyl acrylate crosspolymer,sucrose,yeast extract\faex\extrait de levure,laminaria saccharina extract,lactobacillus ferment,butylene glycol,water\aqua\eau,benzoic acid,phenoxyethanol,potassium sorbate <iln52924>

  • PRINCIPAL DISPLAY PANEL

    CLINIQUE
    acne solutions
    clinical

    advanced clearing gel

    2% SALICYLIC ACID
    ACNE MEDICATION

    0.68 FL.OZ.LIQ/20 ml

    PDP

  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS CLINICAL ADVANCED CLEARING GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-221
    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
    SUCROSE (UNII: C151H8M554)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    YEAST (UNII: 3NY3SM6B8U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-221-011 in 1 CARTON03/03/2025
    120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49527-221-021 in 1 CARTON03/03/2025
    210 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:49527-221-031 in 1 CARTON03/03/2025
    33 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/03/2025
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-221)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC LLC943871157pack(49527-221) , label(49527-221)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-221) , label(49527-221)
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