MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE- niacinamide, adenosine gel 
THERANOTICS CO.,LTD.

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.

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Drug Facts

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.

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QUESTIONS

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

PACKAGE LABEL (Front)

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PACKAGE LABEL (Drug Facts Label)

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MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE 
niacinamide, adenosine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72695-0011
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:72695-0011-27 in 1 CARTON05/01/2020
1NDC:72695-0011-13 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(72695-0011)

Revised: 5/2020
Document Id: 247cf672-1f85-4219-9ebe-1d6c3a644517
Set id: 0de9d971-56b6-427a-94d9-b77e2664daf4
Version: 1
Effective Time: 20200529
 
THERANOTICS CO.,LTD.