MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE- niacinamide, adenosine gel

MEDIKOii Bio Active Vital Shot Ampoule by

Drug Labeling and Warnings

MEDIKOii Bio Active Vital Shot Ampoule by is a Otc medication manufactured, distributed, or labeled by THERANOTICS CO.,LTD., BIO-FD&C. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (Front)

PACKAGE LABEL (Drug Facts Label)

INGREDIENTS AND APPEARANCE

MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE 
niacinamide, adenosine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72695-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72695-0011-2	7 in 1 CARTON	05/01/2020
1	NDC: 72695-0011-1	3 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2020

Labeler - THERANOTICS CO.,LTD. (694963085)

Registrant - THERANOTICS CO.,LTD. (694963085)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C. Co., Ltd.		688203268	manufacture(72695-0011)