MADECA (GLYCERIN, NIACINAMIDE) CREAM [DONGKOOK PHARMACEUTICAL CO., LTD.]

MADECA (GLYCERIN, NIACINAMIDE) CREAM [DONGKOOK PHARMACEUTICAL CO., LTD.]
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NDC 70541-020-01
Set ID d8f99662-cbbd-4f67-bc61-582ef442c8a6
Category HUMAN OTC DRUG LABEL
Packager Dongkook Pharmaceutical Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 2.0%, Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Centella Asiatica Leaf Water, Butylene Glycol, Squalane, Alcohol Denat., Butyrospermum Parkii (Shea) Butter, Hydrogenated Poly(C6-14 Olefin), Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylic/Capric Triglyceride, Cetearyl Alcohol, PEG-40 Stearate, Cyclopentasiloxane, Pentylene Glycol, Synthetic Beeswax, Cyclohexasiloxane, PEG-100 Stearate, Polyacrylate-13, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Asiaticoside, Madecassic Acid, Asiatic Acid, Polyisobutene, Caprylyl Glycol, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Adenosine, Disodium EDTA, 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, Rosa Damascena Flower Oil, Raspberry Seed Oil/Tocopheryl Succinate Aminopropanediol Esters, Polydecene, Dipropylene Glycol, Copaifera Officinalis (Balsam Copaiba) Resin, Jasminum Officinale (Jasmine) Oil, Imperata Cylindrica Root Extract, Sodium Palmitoyl Proline, Artemisia Absinthium Extract, Rose Flower Oil, Camellia Japonica Flower Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Ferula Galbaniflua (Galbanum) Resin Oil, Thuja Occidentalis Leaf Oil, Nymphaea Alba Flower Extract, PEG-8, Carpinus Tschonoskii Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Sodium Polyacrylate, Hedera Helix (Ivy) Leaf/Stem Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Carbomer, Thermus Thermophillus Ferment, Phytic Acid, PPG-1-PEG-9 Lauryl Glycol Ether, Helianthus Annuus (Sunflower) Seed Extract, Morus Bombycis Wood Extract, Lavandula Angustifolia (Lavender) Flower Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Rose Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Monarda Didyma Leaf Extract

  • 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

  • Directions

    Directions: Softly apply cream along the skin texture and pat gently for better absorption.

  • Directions

    Directions: Softly apply cream along the skin texture and pat gently for better absorption.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MADECA 
    glycerin, niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 50 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70541-020-0150 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201607/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/201607/12/2020
    Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
    Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongkook Pharmaceutical Co., Ltd.688003495manufacture(70541-020)

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