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 April 8, 2014

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

  • DESCRIPTION

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

  • INDICATIONS & USAGE

    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), Glycolic Acid, Glycerin, Cetyl Alcohol, Ethylhexyl Palmitate, Ascorbic Acid, Sodium Lauryl Sulfate, Phenyl Trimethicone, Saponins, Tocopheryl Acetate, Methylparaben, Propylparaben, Sodium Metabisulfite, BHT, Disodium EDTA.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 80 g Bottle Carton

    ZO®MEDICAL
    BY ZEIN OBAGI, MD

    NDC 42851-031-80

    08rx

    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:42851-031
    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
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    CAULOSIDE D (UNII: 4N5Z068GAZ)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-031-801 in 1 CARTON
    180 g in 1 BOTTLE, PLASTIC
    2NDC:42851-031-321 in 1 CARTON
    232 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2012
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanitor Coporation797472792MANUFACTURE(42851-031)