Label: MIRU ORIENTAL WHITENING AMPOULE- glycerin liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 6, 2014

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    Aqua, Butylene Glycol, Niacinamide, Glycerin, Aristotelia Chilensis Fruit Extract, Phyllanthus Emblica Fruit Extract, Hippophae Rhamnoides Extract, Pueraria Thunbergiana Root Extract, Angelica Dahurica Root Extract, Saposhnikovia Divaricata Root Extract, Atractyloides Lancea Root Extract, Panax Ginseng Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Root Extract, Astragalus Membranaceus Root Extract, Cimicifuga Dahurica Root Extract, Caulerpa Lentillifera Extract, Codium Fragile Extract,, Silkworm Cocoon Extract, Polygonum Fagopyrum Seed Extract, Aloe Barbadensis Leaf Extract, Cryptomeria Japonica Leaf Extract, Portulaca Oleracea Extract, Centella Asiatica Extract, Hamamelis Virginiana (Witch Hazel) Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Donkey Milk, Camel Milk, Xylitylglucoside, Anhydroxylitol, Xylitol, Dimethicone, Caprylic/Capric Triglyceride, Tremella Fuciformis (Mushroom) Extract, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Lecithin, Hydrolyzed Collagen, Cholesterol, Silica, Methicone, Cyclomethicone, Octyldodecyl Neopentanoate, Dicaprylyl Carbonate, Polyglyceryl-6 polyricinoleate, Sodium Hyaluronate, Glyceryl Caprylate, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide, Cetearyl Alcohol , Sorbitan Sesquioleate, Panthenol, Hydroxypropyl Cyclodextrin, Thioctic Acid, 1,2-Hexanediol, Potassium Hydroxide, Allantoin, Triethanolamine, Lecithin, Carbomer, Disodium EDTA, Perfume


  • PURPOSE

    ultimate brightening solution ampoule with moisturizing


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply it to face and smooth the whole face using a patting motion for absorbing well


  • WARNINGS

    avoid contact with eyes
    discontinue use if signs of irritation appear


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    MIRU ORIENTAL WHITENING AMPOULE 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62620-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0224 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62620-2001-210 in 1 PACKAGE
    1NDC:62620-2001-12 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/06/2014
    Labeler - Fedora International Co., Ltd. (689049099)
    Registrant - Fedora International Co., Ltd. (689049099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fedora International Co., Ltd.689049099manufacture(62620-2001)