Label: MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE STARTER KIT- niacinamide, adenosine gel

  • 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, Water, Butylene Glycol, 1,2-Hexanediol, Glycerin, Resveratrol, Chlorogenic Acids, Ferulic Acid,
    Sodium Hyaluronate, Nicotinoyl Tripeptide-1 , sh-Decapeptide-9, sh-Pentapeptide-5, Caffeoyl Tripeptide-1, sh-Oligopeptide-1, sh-Polypeptide-1,
    Rhizophora Mangle Callus Culture Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Monarda Didyma Leaf Extract, Freesia Refracta Extract, Mentha Piperita (Peppermint) Leaf Extract ,Polyglutamic Acid, Betaine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer,, Hydroxyethyl Urea, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Allantoin, Sodium Polyacrylate, Disodium EDTA, Glyceryl Acrylate/Acrylic Acid Copolymer, Lavandula Angustifolia (Lavender) Oil, Tromethamine, Propylene Glycol, Coceth-7, PEG-40 Hydrogenated Castor Oil, PPG-1-PEG-9 Lauryl Glycol Ether, Panthenol, Ethylhexylglycerin, CI 19140, CI 42090

  • 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 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 syringe cap
    3) Insert the cap into the bottom of syringe and press gently. Make sure you only squeeze out a small amount of ampoule since it is highly concentrated.
    4) Apply on entire face twice a day.

  • QUESTIONS

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE STARTER KIT 
    niacinamide, adenosine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72695-0010
    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
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72695-0010-22 in 1 CARTON05/01/2020
    1NDC:72695-0010-13 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(72695-0010)