Label: ACNE SOLUTIONS LIQUID MAKEUP SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid

  • NDC Code(s): 49527-751-01
  • Packager: CLINIQUE LABORATORIES LLC
  • 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 April 27, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:    SALICYLIC ACID 0.5%

  • PURPOSE

    PURPOSE: ACNE TREATMENT  

  • INDICATIONS & USAGE

    USES:

    • TREATS ACNE
    • HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES
  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY. 

  • WHEN USING

    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

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION


    DIRECTIONS

    • SHAKE WELL BEFORE USE
    • CLEANSE SKIN THOROUGHLY BEFORE APPLYING
    • COVER THE ENTIRE AFFECTED AREA WITH ONE APPLICATION
    • GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    METHYL TRIMETHICONE [] WATER [] DIPROPYLENE GLYCOL [] ALCOHOL DENAT. [] NYLON-12 [] BUTYLENE GLYCOL [] TALC [] PEG-10 DIMETHICONE [] DIMETHICONE [] TRIMETHYLSILOXYSILICATE [] SILICA [] LAMINARIA SACCHARINA EXTRACT [] CALCIUM STEARATE [] ISONONYL ISONONANOATE [] CAFFEINE [] GLYCERIN [] HYDROXYAPATITE [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] SORBITAN SESQUIOLEATE [] DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] QUATERNIUM-90 BENTONITE [] 10-HYDROXYDECANOIC ACID [] LECITHIN [] TOCOPHEROL [] SODIUM CHLORIDE [] TROMETHAMINE [] PROPYLENE CARBONATE [] ALUMINA [] DISODIUM EDTA [] SODIUM CITRATE [] PHENOXYETHANOL MAY CONTAIN: TITANIUM DIOXIDE [] IRON OXIDES[] MICA       ILN36140 

  • PRINCIPAL DISPLAY PANEL

    PRINCIPLE DISPLAY PANEL 1 FL OZ/ 30 ML FOLDING CARTON





    CLINIQUE ACNE SOLUTIONS

    LIQUID MAKEUP

    SALICYLIC ACID ACNE TREATMENT



    1 FL OZ / 30 mL







    CLINIQUE LABS DISTR

    NY, NY 10022



    6WPR

    CLINIQUE.COM


    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS LIQUID MAKEUP  SALICYLIC ACID ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-751
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALCOHOL (UNII: 3K9958V90M)  
    NYLON-12 (UNII: 446U8J075B)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BENTONITE (UNII: A3N5ZCN45C)  
    10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-751-011 in 1 CARTON12/04/2020
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00612/04/2020
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture(49527-751) , pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-751) , pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-751) , pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-751) , label(49527-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(49527-751) , label(49527-751)
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