Label: MEDI WRINKLE CREAM- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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 March 23, 2017

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  • ACTIVE INGREDIENT

    Dimethicone (1%) - Skin Protectact
    Allantoin (0.01%) - Skin Protectact

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Glycerin, Cetyl 2-Ethylhexanoate , Niacinamide, Sodium Hyaluronate, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexandiol, Hydroxyethylethylcelluose, Cetearyl Glucoside, Sorbitan Olivate, Cetearyl Alcohol, Niacinamide, Sodium Hyaluronate, Stearic acid, Propylene Glycol, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCl, Maltodextrin / Sodium Starch Octenylsuccinate, Cetearyl Alcohol, Argania Spinosa Kernel Oil, Orbignya Oleifera Seed Oil, Tocopherol, Camellia Sinensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavendula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hydrolyzed Collagen,Hydrogenated Lecithin, Ceramide NP, PEG-10 Rapeseed sterol, Dipropylene Glycol, Glyceryl Stearate, Glycereth-20, Beeswax, Carthamus Tinctorius (Safflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olus (Vegetable) Oil, Tocopherol, Macadamia Integrifolia Seed Oil, Octanediol, Ethylhexylglycerin, Citrus grandis (grapefruit) seed extract, Artemisia princeps extract, Carbomer, Triethanolamine, Caprylyl Glycol, PPG-26 Buteth-26, PEG-40 Hydrogenated Caster oil, Alcohol, Phenoxyethanol, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Copper Tripeptide-1, Fragrance, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Xanthan Gum, Adenosine, Disodium EDTA

  • PURPOSE

    Skin Protectact

  • WARNINGS

    For skin use only.
    Do not use
     on puncture wounds  on animal bites  on serious burns  on area with scratches, eczema, or dermatitis
    When using this product
     avoid contact with eyes
    Stop use and ask a doctor if
     you have allergy or skin disease
     rash or irritation develops and lasts
     red spots, swelling, itching, irritation and other abnormalities develops

  • KEEP OUT OF REACH OF CHILDREN

     if swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

     Clean skin thorounghly before using
     After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
     Use it every days in the evening according to skin condition

  • DOSAGE & ADMINISTRATION

     Clean skin thorounghly before using
     After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
     Use it every days in the evening according to skin condition

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEDI WRINKLE CREAM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71327-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.0021 g  in 210 mL
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.000021 g  in 210 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methionine (UNII: AE28F7PNPL)  
    Serine (UNII: 452VLY9402)  
    Histidine (UNII: 4QD397987E)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71327-004-01210 mL in 1 PACKAGE; Type 0: Not a Combination Product03/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2017
    Labeler - MICELL KOREA CO.,LTD (689851542)
    Registrant - MICELL KOREA CO.,LTD (689851542)
    Establishment
    NameAddressID/FEIBusiness Operations
    MICELL KOREA CO.,LTD689851542manufacture(71327-004)