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ACNE SOLUTIONS (CLINIQUE LABORATORIES INC)

Available Formats

Dosage Form Package Information Links
LOTION 1 TUBE in 1 CARTON (49527-718-01) > 15 mL in 1 TUBE (49527-718-02) Label Information

Complete ACNE SOLUTIONS Information

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: BENZOYL PEROXIDE 0.5%

    water [] c12-15 alkyl benzoate [] glycerin [] cetearyl alcohol [] steareth-2 [] sucrose [] steareth-20 [] polyacrylamide [] dimethicone [] glyceryl stearate [] peg-100 stearate [] acetyl glucosamine [] camellia sinensis leaf extract [] caffeine [] yeast extract (faex) [] cola nitida extract [] laminaria saccharina extract [] sea whip extract [] c13-14 isoparaffin [] butylene glycol [] laureth-7 [] chloroxylenol [] phenoxyethanol


  • PURPOSE

    USES:

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

  • WARNINGS

    WARNING: FOR EXTERNAL USE ONLY


  • DO NOT USE

    DO NOT USE IF YOU

    • HAVE VERY SENSITIVE SKIN
    • ARE SENSITIVE TO BENZOYL PEROXIDE

  • WHEN USING

    WHEN USING THIS PRODUCT

    • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME
    • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
    • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH
    • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
    • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION

  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • IRRITATION BECOMES SEVERE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


  • INDICATIONS & USAGE

    DIRECTIONS:

    • CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT
    • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY
    • BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DOY OR EVERY OTHER DAY
    • IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR
    • FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION

     COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    CLINIQUE

    ACNE SOLUTIONS

    EMERGENCY

    GEL-LOTION

    BENZOYL PEROXIDE

    ACNE MEDICATION

    ALL SKIN TYPES



    0.5 FL OZ LIQ. / 15 ML




    CLINIQUE LABORATORIES DIST
    NEW YORK, NEW YORK 10022

    FOLDING CARTON







  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS  EMERGENCY
    benzoyl peroxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-718
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    SUCROSE (UNII: C151H8M554)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    YEAST (UNII: 3NY3SM6B8U)  
    COLA NITIDA SEED (UNII: PQM9SA369U)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49527-718-01 1 in 1 CARTON
    1 NDC:49527-718-02 15 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 12/01/2000
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aramis Inc. 042918826 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Bristol 949264774 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Keystone 618107429 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd. 255175580 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd 253616536 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Whitman Laboratories Ltd. 216866277 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    CONTRACT PHARMACEUTICALS 248761249 manufacture