MADECA DERMA INTENSIVE VITAL CREA M (NIACINAMIDE, ADENOSINE) CREAM [DONGKOOK PHARMACEUTICAL CO., LTD.]

MADECA DERMA INTENSIVE VITAL CREA M (NIACINAMIDE, ADENOSINE) CREAM [DONGKOOK PHARMACEUTICAL CO., LTD.]
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NDC 70541-070-01, 70541-070-02
Set ID f692efdd-6ca2-4b70-8a4c-e0fd367da31c
Category HUMAN OTC DRUG LABEL
Packager Dongkook Pharmaceutical Co., Ltd.
Generic Name
Product Class Adenosine Receptor Agonist
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Centella asiatica extract, Cyclopentasiloxane, Alcohol, Glycerin, Methylpropanediol, Cetearyl alcohol, Hydrogenated poly(C6-14 olefin), Neopentyl glycol diheptanoate, Water, PEG-100 hydrogenated castor oil, Phospholipids, Polyglyceryl-10 myristate, Dioscorea japonica root extract, Glyceryl stearate, PEG-100 stearate, Hydrogenated lecithin, Behenyl alcohol, Hydrogenated polydecene, Phytosteryl/behenyl/octyldodecyl lauroyl glutamate, 1,2-hexanediol, Arctium lappa root extract, Phellinus linteus extract, Piper methysticum leaf/root/stem extract, Madecassic acid, Asiaticoside, Phenoxyethanol, Pentylene glycol, Asiatic acid, Squalane, Dimethicone, Hydrogenated polyisobutene, Caprylyl glycol, Betaine, Ethylhexylglycerin, Polyquaternium-51, Rubus chamaemorus seed extract, Tocopheryl acetate, Myrciaria dubia fruit extract, Glycosyl trehalose, Butylene glycol, Argania spinosa kernel oil, Isononyl isononanoate, Polyglyceryl-10 stearate, Fragrance, Hydrogenated starch hydrolysate, Trisodium EDTA, Raffinose, Biosaccharide gum-1, Butyrospermum parkii (shea) butter, Polyglyceryl-2 dipolyhydroxystearate, Stearic acid, Arginine, Lecithin, Xanthan gum, PVM/MA copolymer, Sodium hyaluronate, Sodium lauroyl lactylate, Sodium polyacrylate, Inulin lauryl carbamate, Sorbitan laurate, Ceramide NP, Folic acid, Cholesterol, Disodium stearoyl glutamate, Hydrolyzed hyaluronic acid, Hydrolyzed lupine protein, Hydroxyethylcellulose, Ceramide AP, Phytosphingosine, Carbomer, Tromethamine, Maltodextrin, Hydrolyzed vegetable protein, Saccharide hydrolysate, Ceramide EOP, Panthenol, Acetyl dipeptide-1 cetyl ester, Palmitoyl tripeptide-5, Acetyl hexapeptide-8, Palmitoyl pentapeptide-4

  • PURPOSE

    Purpose: Skin Brightening, Anti Wrinkle

  • WARNINGS

    Warnings:

    1.For external use only. 2. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 3. Use with caution if you are highly sensitive to any bandages or wet compresses. 4. Do not use the product on an open skin wound or on areas of eczema or infection. 5. 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. 6. 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

  • Uses

    Uses:

    TECA-S and naturally-derived ingredients provide nourishing moisture to help restore your skin’s natural vitality.

  • Direction

    Directions:

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MADECA DERMA INTENSIVE VITAL  CREA M
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 g  in 50 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.02 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70541-070-021 in 1 CARTON05/01/201801/01/2021
    1NDC:70541-070-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/201801/01/2021
    Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
    Registrant - Dongkook PharmaceuDongkook Pharmaceutical Co., Ltd.tical Co., Ltd. (688003495)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(70541-070)

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