Label: ACNE SOLUTIONS CLINICAL CLEARING GEL- salicylic acid gel

  • NDC Code(s): 49527-116-01, 49527-116-02, 49527-116-03
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1%

  • Purpose

    Acne Treatment

  • Uses

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

    For external use only

    When using this productusing 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 product is swallowed, call a doctor or contact a Poison Control Center right away.

  • Directions

    • apply a thin layer to entire face twice a day after cleansing
    • avoid eye area
    • spot-apply if you are using another leave-on acne treatment
    • if bothersome dryness or peeling occurs, reduce usage to every other day
  • Inactive ingredients

    alcohol denat.,hamamelis virginiana (witch hazel) water,alcohol,acrylates/c10-30 alkyl acrylate crosspolymer,water\aqua\eau,laminaria saccharina extract,butylene glycol,benzalkonium chloride <iln52627>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL

    acne

    CLINIQUE

    acne solutions
    clinical

    clearing gel

    SALICYLIC ACID
    ACNE MEDICATION

    ALL SKIN TYPES

    1 FL.OZ.LIQ./30 ml e

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS  CLINICAL CLEARING GEL
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-116
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-116-011 in 1 CARTON12/21/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49527-116-021 in 1 CARTON12/21/2023
    215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49527-116-031 in 1 CARTON12/21/2023
    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 DrugM00612/21/2023
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-116) , pack(49527-116) , label(49527-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-116) , pack(49527-116) , label(49527-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774pack(49527-116) , label(49527-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-116) , label(49527-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-116) , label(49527-116)
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