LYCORIS RUBUS WHITENING (ALLANTOIN) CREAM [LYCORIS CO., LTD.]

LYCORIS RUBUS WHITENING (ALLANTOIN) CREAM [LYCORIS CO., LTD.]
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NDC 60778-030-01
Set ID 261000bd-8877-48d8-bf51-7b81f3a7529e
Category HUMAN OTC DRUG LABEL
Packager Lycoris Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Arbutin, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Bis-PEG-18MethylEtherDimethylSilane, Butylene Glycol, Cyclohexasiloxane Rubus Hirsutus Fruit/Leaf Extract(2%), Sodium Hyaluronate, Betaine,Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, PEG-40 Stearate, Stearic acid, GlycerylStearate, Phenoxyethanol, Cetearyl Glucoside, Hydrogenated Lecithin Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Camellia Japonica Ovary Powder, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate Carbomer, Sodium Metabisulfite, Disodium EDTA, Xanthan Gum, Caramel, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problem such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In the case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LYCORIS RUBUS WHITENING 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60778-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.25 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60778-030-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2013
    Labeler - Lycoris Co., Ltd. (688301521)
    Registrant - Lycoris Co., Ltd. (688301521)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lycoris Co., Ltd.688301521manufacture(60778-030)

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