MEDIKOii Bio Repair CICA

Manufacturer
THERANOTICS CO.,LTD. | BIO-FD&C. Co., Ltd.
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:22

Label at a glance#

ProductMEDIKOii Bio Repair CICA
Active ingredientNiacinamide, ADENOSINE
Label structure9 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2.00%
Adenosine 0.04%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Skin Brightening
Anti wrinkle

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ 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

DOSAGE & ADMINISTRATION SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72695-0013-22023-01-30C16284748780-1f386c64a-135f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72695-0013-1MEDIKOii Bio Repair CICA50 mL in 1 CONTAINERCREAM501
72695-0013-2MEDIKOii Bio Repair CICA1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72695-0013MEDIKOII BIO REPAIR CICA (NIACINAMIDE, ADENOSINE) CREAM [THERANOTICS CO.,LTD.]1Legacy NDC, 2 package rows20200530_acc42027-2c90-442f-a0a2-c624c7d6a1a8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72695-001372695-0013-1, 72695-0013-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Niacinamide25X51I8RD4ACTIB
ADENOSINEK72T3FS567ACTIB
OLIVE OIL6UYK2W1W1EIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48070427-ecbf-4fea-8ec1-43f453af021aacc42027-2c90-442f-a0a2-c624c7d6a1a82020-05-29WarningsExact identifier
spl id: 48070427-ecbf-4fea-8ec1-43f453af021a
spl set id: acc42027-2c90-442f-a0a2-c624c7d6a1a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.