Label: MELAMIX SKIN LIGHTENER AND BLENDING- hydroquinone cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 6, 2014

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

  • INDICATIONS & USAGE

    Melamix™ contains 4% Hydroquinone, which is used for the treatment of pigmentation problems. It helps to even color tone by inhibiting melanin production.

    Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

  • DOSAGE AND ADMINISTRATION

    Apply 2 pumps (1 g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

  • WARNINGS

    Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

    SUNBURN ALERT

    This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

  • STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

  • ACTIVE INGREDIENT

    Hydroquinone 4%

    INACTIVE INGREDIENTS

    Water (Aqua), Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Lauryl Glucoside, Stearyl Alcohol, Helianthus Annuus Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Ascorbic Acid, Phenoxyethanol, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica Extract, Ascorbyl Palmitate, Chlorphenesin, Disodium EDTA, Caprylyl Glycol, Stachys Officinalis Extract, Saponins.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

    "ZO" is a registered trademark of ZO Skin Health, Inc.

    MADE IN USA 080500

    zomedical.com

  • PRINCIPAL DISPLAY PANEL 80 g Bottle Carton

    ZO®MEDICAL
    BY ZEIN OBAGI, MD

    NDC 42851-033-80

    MELAMIX™
    Skin Lightener &
    Blending Crème

    Hydroquinone USP, 4%

    RX ONLY

    Net Wt. 80 g / 2.8 Oz.

    Principal Display Panel 80 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MELAMIX SKIN LIGHTENER AND BLENDING 
    hydroquinone cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
    CURDLAN (UNII: 6930DL209R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAULOSIDE D (UNII: 4N5Z068GAZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-033-801 in 1 CARTON
    180 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:42851-033-321 in 1 CARTON
    232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/01/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(42851-033)