Label: CLINIQUE CLARIFYING MAKEUP- salicylic acid powder

  • Category: HUMAN OTC DRUG LABEL

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 January 20, 2011

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  • ACTIVE INGREDIENT


    ACTIVE INGREDIENT:    SALICYLIC ACID 0.5%
  • PURPOSE

    PURPOSE:  ACNE TREATMENT

    USE:  FOR THE TREATMENT OF ACNE

    CLEARS UP ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

    HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

    INDICATIONS: FOR THE TREATMENT OF ACNE

  • 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
    • 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:
    talc [] dimethicone [] silica [] zea mays (corn) starch [] polymethyl methacrylate [] zinc stearate [] cetearyl ethylhexanoate [] trimethylsiloxysilicate [] sucrose [] ethylhexylglycerin [] nylon-12 [] octyldodecyl lactate [] lauroyl lysine [] pca [] lauryl alcohol [] bht [] chlorphenesin [] potassium sorbate [] tetrasodium edta []  [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891) [] yellow 5 lake (ci 19140) [] chromium oxide greens (ci 77288) [] chromium hydroxide green (ci 77289) [] carmine (ci 75470) [] bismuth oxychloride (ci 77163) [] blue 1 lake (ci 42090) [] yellow 6 lake (ci 15985) [] red 7 lake (ci 15850) [] red 6 (ci 15850) [] red 30 (ci 73360) [] ferric ferrocyanide (ci 77510

  • PRINCIPAL DISPLAY PANEL


    PRINCIPLE DISPLAY PANEL:
     


    CLINIQUE

    CLARIFYING POWDER MAKEUP

    NET WT. .38 OZ/11 g

    clinique labs dist

    new york, ny 10022


    folding carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE  CLARIFYING MAKEUP
    salicylic acid powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    SUCROSE (UNII: C151H8M554)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-006-01 1 in 1 CARTON
    1NDC:49527-006-0211 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2010
    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
    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 Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    INTERCOS338578473manufacture
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