Label: MEDISILKE- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 13, 2010

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  • Active Ingredient

    Hydroquinone 2%

  • Purpose

    Skin bleaching agent.

  • Uses

    For the gradual fading of brownish spots.

  • Inactive Ingredients

    Water, SD Alcohol 40, Glyceryl Stearyl Citrate, Butylene Glycol, Ethylhexyl Palmitate, Methylpropanediol, Behenyl Alcohol, Glycerin,Sodium Hyaluronate, Disodium EDTA, Xanthan Gum, HydroxyethylCellulose, Cetearyl Alcohol, Cetearate-20, BHT, Glyceryl Dilaurate, Dimethicone, Hydroxyethyl Acrylate,Sodium AcryloylDimethyl Taurate Copolymer, Squalane, Polysorbate 60, Bambusa Vulgaris Leaf/Stem Extract, Pisum Sativum(Pea) Extract, Glucosamine HCl, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Seed Extract, Retinol, Allyl Methacrylate Crosspolymer, Polysorbate 20, Camellia Sinensis Leaf Extract, EthylHexylglycerin, Methylisothiazolinone, Phenoxyethanol Capryl Glycol, Potassium Sorbate, Hexylene glycol, Glycyrrhiza Glabra (licorice) Root Extract. Citric Acid Tocopheryl Acetate, Caprylic/Capric Triglyceride, Macadamia Ternifola Seed Oil Retinyl Palmitate, Zea Mays (Corn Oil, Ubiquinone, Palmitic Acid, Thioctic Acid, Beta-Carotene, Heluanthus Annus (Sunflower) Seed Oil.

  • Directions

    Adults: apply a small amount as a thin layer on the affected area twice daily to affected area or use as directed by a physician. If no improvement is seen after 3 months of treatment, use of this product should discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.

    Children under 12 years of age: do not use unless directed by a doctor.

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Some users of this product 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 age unless directed by a physician.

    If swallowed get medical help or contact a posion control center.

  • Questions or Comments?

    Moss Pharmaceuticals, P.O. Box 1426, Port Washington, NY 11060.
    www.Medisilke.com

  • SPL UNCLASSIFIED SECTION

    Manufactured by: NEW GPC INC., A1 Farm, EBD, Guyana under license for Moss Pharmaceuticals LLC, USA.

  • PRINCIPAL DISPLAY PANEL - 20g Tube Carton

    Medisilke
    NIGHT CREAM
    Skin lightening cream / fades brown spots and skin discoloration

    20g

    PRINCIPAL DISPLAY PANEL - 20g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEDISILKE   NIGHT
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65588-2230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)  
    BAMBUSA VULGARIS STEM (UNII: SMR633LHTC)  
    APPLE (UNII: B423VGH5S9)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    RETINOL (UNII: G2SH0XKK91)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    HELIANTHUS ANNUUS (UNII: BKJ0J3D1BP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65588-2230-31 in 1 CARTON
    120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart358A12/01/2009
    Labeler - New GPC, Inc. (895025443)
    Establishment
    NameAddressID/FEIBusiness Operations
    New GPC, Inc.895025443MANUFACTURE
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