MEDIKOII BIO REPAIR CICA- niacinamide, adenosine cream

MEDIKOii Bio Repair CICA by

Drug Labeling and Warnings

MEDIKOii Bio Repair CICA 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, 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

INGREDIENTS AND APPEARANCE

MEDIKOII BIO REPAIR CICA 
niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72695-0013
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
OLIVE OIL (UNII: 6UYK2W1W1E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72695-0013-2	1 in 1 CARTON	05/01/2020
1	NDC: 72695-0013-1	50 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(72695-0013)