MADECA DERMA MASK II (GLYCERIN, NIACINAMIDE) PATCH [DONGKOOK PHARMACEUTICAL CO., LTD.]

MADECA DERMA MASK II (GLYCERIN, NIACINAMIDE) PATCH [DONGKOOK PHARMACEUTICAL CO., LTD.]
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NDC 70541-030-01, 70541-030-02
Set ID 2cbdb03a-0e8b-4063-a53e-9d1ec7821812
Category HUMAN OTC DRUG LABEL
Packager Dongkook Pharmaceutical Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 5.0%, Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Dipropylene Glycol, Caprylic/Capric Triglyceride, Alcohol Denat., Cetearyl Alcohol, Glyceryl Stearate, Dimethicone, Hydroxyacetophenone, Cyclopentasiloxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyclohexasiloxane, Xanthan Gum, Allantoin, Caffeine, Tromethamine, Caprylyl Glycol, Ethylhexylglycerin, Adenosine, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Asiaticoside, Madecassic Acid, Butylene Glycol, Asiatic Acid, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Cananga Odorata Flower Oil, Cedrus Atlantica Bark Oil, Phenoxyethanol, Althaea Rosea Flower Extract, Rosa Damascena Flower Oil, Aqua, Copaifera Officinalis (Balsam Copaiba) Resin, Jasminum Officinale (Jasmine) Oil, Centella Asiatica Leaf Extract, Saccharide Isomerate, Artemisia Absinthium Extract, Rose Flower Oil, Xylitylglucoside, Anhydroxylitol, Propanediol, Ferula Galbaniflua (Galbanum) Resin Oil, Pseudoalteromonas Ferment Extract, Thuja Occidentalis Leaf Oil, Xylitol, Hydrolyzed Rice Protein, Algae Extract, Magnesium Aspartate, Zinc Gluconate, Glutamic Acid, Glycoproteins, Sodium Benzoate, Asparagus Officinalis Stem Extract, Cladosiphon Novae-Caledoniae Extract, Potassium Sorbate, Citric Acid, Copper Gluconate, Glycine Soja (Soybean) Protein, Superoxide Dismutase, Threonine, Valine, Calcium Gluconate, Gluconolactone Sodium Citrate, Alanine, Palmitoyl Tripeptide-5, Proline, Serine, Sodium Phosphate, Acetyl Hexapeptide-8, Sodium Dextran Sulfate, Sodium Metabisulfite, Sodium Hydroxide

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 2. Use with caution if you are highly sensitive to any bandages or wet compresses. 3. Do not use the product on an open skin wound or on areas of eczema or infection. 4. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 5. Storage and handling instructions 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: 1. After cleansing your face, apply skin toner. 2. Take the product out of the package and adhere it evenly over your face avoiding the eye and mouth area. 3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining product into the skin until thoroughly absorbed.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: Use immediately after opening.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MADECA DERMA MASK II 
    glycerin, niacinamide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.25 g  in 25 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.5 g  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70541-030-0210 in 1 CARTON05/01/201607/12/2020
    1NDC:70541-030-0125 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/201607/12/2020
    Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
    Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongkook Pharmaceutical Co., Ltd.688003495manufacture(70541-030)

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