Label: MEDIKOII BIO REPAIR CICA- niacinamide, adenosine cream

  • 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 May 29, 2020

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

  • ACTIVE INGREDIENTS

    Niacinamide 2.00%
    Adenosine 0.04%

  • INACTIVE INGREDIENTS

    Myrothamnus Flabellifolia Callus Culture Extract, Olea Europaea (Olive) Fruit Oil, Water, Caprylic/Capric Triglyceride, Butylene Glycol, Macadamia Ternifolia Seed Oil, Corylus Avellana (Hazel) Seed Oil, Glycerin, 1,2-Hexanediol, Hydroxyethyl Acrylate/SodiumAcryloyldimethyl Taurate Copolymer, Glyceryl stearate, Cetearyl Alcohol, Magnesium Ascorbyl Phosphate, Squalane, Polysorbate 60, Hydroxyethyl Urea, Resveratrol, Chlorogenic Acids, Ferulic Acid, Nicotinoyl Tripeptide-1, sh-Decapeptide-9, sh-Pentapeptide-5, CaffeoylTripeptide-1, sh-Oligopeptide-1, sh-Polypeptide-1, Leontopodium Alpinum Callus Culture Extract, Lavandula Angustifolia (Lavender) Water, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago Officinalis Extract, Centaurea Cyanus Flower Extract, Salvia Sclarea (Clary)Extract, Hyacinthus Orientalis Extract, Sodium Hyaluronate, Panthenol, Polyglutamic Acid, Beeswax, Butyrospermum Parkii (Shea) Butter, Polyacrylate-13, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Santalum Album (Sandalwood) Oil, Carbomer, Euphorbia Cerifera (Candelilla) Wax, Tromethamine, PEG-100 stearate, Polyisobutene, Betaine, Sorbitan Sesquioleate, TocopherylAcetate, Polysorbate 20, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Dipotassium Glycyrrhizate, PropyleneGlycol, Allantoin, Disodium EDTA, Ethylhexylglycerin

  • PURPOSE

    Skin Brightening
    Anti wrinkle

  • WARNINGS

    1.If you experience any symptoms such as redness, swelling, or itchiness during usage or from exposure to direct sunlight after usage, suspend use and consult a physician.
    2. Do not use on wounds or other areas of skin irritation.
    3. Storage and handling
    a. Keep out of reach of children.
    b. Keep away from direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■ Helps brighten skin tone and improve wrinkles to disappear
    ■ Helps moisturizing and alleviates dryness
    ■ Helps anti-oxidation process within skin and possibly hinders aging-mechanism.

  • Directions

    1) After washing your face, arrange your skin texture with toner.
    2) Open the product by removing the cap.
    3) Take enough amount for entire face and apply gently.

  • QUESTIONS

    Website: www.medikoii.com
    Person in charge: jslee@theranotics.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MEDIKOII BIO REPAIR CICA 
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72695-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72695-0013-21 in 1 CARTON05/01/2020
    1NDC:72695-0013-150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - THERANOTICS CO.,LTD. (694963085)
    Registrant - THERANOTICS CO.,LTD. (694963085)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO-FD&C. Co., Ltd.688203268manufacture(72695-0013)