Label: ACNE SOLUTIONS CLEARING CONCEALER ACNE MEDICATION ALL SKIN TYPES- salicylic acid lotion

  • 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 1, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT


    ACTIVE INGREDIENT: 1.0% SALICYLIC ACID
  • PURPOSE

    PURPOSE: ACNE TREATMENT

    USE: TREATS ACNE

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY. AVOID EYE AREA

  • 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
    • 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: WATER , BUTYLENE GLYCOL , CETYL ESTERS , STEARIC ACID , KAOLIN , GLYCERYL DILAURATE , HYDROGENATED POLYISOBUTENE , STEARETH-21 , LAMINARIA SACCHARINA EXTRACT , CAFFEINE , PEG-150 PENTAERYTHRITYL TETRASTEARATE , STEARETH-2 , GLYCERYL STEARATE , LECITHIN , ACETYL GLUCOSAMINE , CELLULOSE GUM , 10-HYDROXYDECANOIC ACID , MAGNESIUM ALUMINUM SILICATE, , SILICA , XANTHAN GUM , AMINOMETHYL PROPANEDIOL , SIMETHICONE , TOCOPHERYL ACETATE , DISODIUM EDTA , PHENOXYETHANOL , POTASSIUM SORBATE  MAY CONTAIN: MICA, TITANIUM DIOXIDE, IRON OXIDES, CHROMIUM OXIDE GREENS  ILN35126

  • PRINCIPAL DISPLAY PANEL


    PRINCIPLE DISPLAY PANEL   0.34 FL OZ LIQ CARTON

    CLINIQUE ACNE SOLUTIONS CLEARING CONCEALER
    SALICYLIC ACID ACNE MEDICATION

    ALL SKIN TYPES

    .34 FL OZ/ 10 mL


    CLINIQUE LABS DISTR.
    NEW YORK, NY 10022
    CLINIQUE.COM

    FOLDING CARTON



  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS CLEARING CONCEALER  ACNE MEDICATION ALL SKIN TYPES
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-749
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.0 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-749-011 in 1 CARTON
    1NDC:49527-749-0210 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/02/2008
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1110482184manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636manufacture, label, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture