MEDIKOii Bio Active Vital Shot Ampoule Starter Kit

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 Active Vital Shot Ampoule Starter Kit
Active ingredientNiacinamide, ADENOSINE
Label structure9 sections

Indications and uses

■ Helps brighten skin tone and improve wrinkles to disappear ■ 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 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.

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, 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

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 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 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

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
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72695-0010-22023-01-30C16284748780-1f386c64a-0de6-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72695-0010-1MEDIKOii Bio Active Vital Shot Ampoule Starter Kit3 mL in 1 CONTAINERGEL31
72695-0010-2MEDIKOii Bio Active Vital Shot Ampoule Starter Kit2 in 1 CARTONGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72695-0010MEDIKOII BIO ACTIVE VITAL SHOT AMPOULE STARTER KIT (NIACINAMIDE, ADENOSINE) GEL [THERANOTICS CO.,LTD.]1Legacy NDC, 2 package rows20200530_dea38bba-2110-4175-abab-e2e3ebfe36db.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
72695-001072695-0010-1, 72695-0010-2

Ingredients#

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

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

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
5954a7bd-bee2-4bfc-8976-921e7dc4969fdea38bba-2110-4175-abab-e2e3ebfe36db2020-05-29WarningsExact identifier
spl id: 5954a7bd-bee2-4bfc-8976-921e7dc4969f
spl set id: dea38bba-2110-4175-abab-e2e3ebfe36db

Reported adverse events (FAERS/openFDA)#

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