Label: EDGE CUTIMAL CAT WHITENING MASK- niacinamide face mask patch

  • NDC Code(s): 70889-100-01
  • Packager: Oneskin Cosmetics Co., Ltd.
  • Category: HUMAN OTC 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 November 8, 2016

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

  • ACTIVE INGREDIENT

    Niacinamide 2.00%

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  • PURPOSE

    Skin Protectant

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  • INDICATIONS & USAGE

    • Protects, restores and soothes the skin
    • Softens, smoothens, enhances radiance and brightens skin
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  • DOSAGE & ADMINISTRATION

    Apply evenly to clean face, avoiding eye area.

    Leave on for 15-20 minutes, remove the mask and pat skin gently to allow the any residue to be absorbed into skin well.

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  • WARNINGS

    For external use only

    • Do not use on areas with wounds, eczema, or dermatitis.
    • Stop use and ask a doctor if you have

    a. Redness, swelling, itchiness, irritation, or other similar symptoms.
    b. Occurrence of the above symptoms upon exposure to direct sunlight.

    • When using this product, keep out of eyes. If eye contact occurs, rinse well with water.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

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  • INACTIVE INGREDIENT

    Water, Glycerin, Butylene Glycol, Sodium Hyaluronate, Portulaca Oleracea Extract, Betaine, Sodium Ascorbyl Phosphate, ipotassium Glycyrrhizate, Morus Alba Bark Extract, Beta-Glucan, Ethylhexylglycerin, Glyceryl Caprylate, Scutellaria Baicalensis Root Extract, Citrus Paradisi (Grapefruit) Seed Extract, Chamomilla Recutita (Matricaria) Extract, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Allantoin, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Tocopheryl Acetate, Potassium Hydroxide, Methylparaben, Punica Granatum Fruit Extract, Rosa Damascena Flower Extract, Taraxacum Officinale (Dandelion) Leaf Extract, Rhodiola Rosea Root Extract, Olea Europaea (Olive) Leaf Extract , Glycyrrhiza Glabra (Licorice) Root Extract, Fragrance.

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  • OTHER SAFETY INFORMATION

    Do not store in areas with extreme heat or cold, or under direct sunlight.

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  • INGREDIENTS AND APPEARANCE
    EDGE CUTIMAL CAT WHITENING MASK 
    niacinamide face mask patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70889-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.5 g  in 25 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    BETAINE (UNII: 3SCV180C9W)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
    TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ROSA DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70889-100-01 10 in 1 BOX 11/01/2016
    1 25 g in 1 PACKAGE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/01/2016
    Labeler - Oneskin Cosmetics Co., Ltd. (689846630)
    Registrant - Oneskin Cosmetics Co., Ltd. (689846630)
    Establishment
    Name Address ID/FEI Business Operations
    Oneskin Cosmetics Co., Ltd. 689846630 manufacture(70889-100)
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