FDA.reportPublic FDA data

reFACE TOX AMPULE

Manufacturer
Woorhi Mechatronics Co., Ltd. | Ester Co., Ltd.
Effective date
2021-06-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:06

Label at a glance#

ProductreFACE TOX AMPULE
Active ingredientNiacinamide, Adenosine
Label structure8 sections

Indications and uses

■ This solution controls forming wrinkle with Korea patented cosmetic composition “RealTox”. ■ Helps improve the brightness skin tone ■ Helps reduce the appearance of fine lines and wrinkles

Dosage and administration

■ Apply the adequate amount on face and cover up face with hands to be absorbed

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2.0%, Adenosine 0.04%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Glycerin, Protease, 1,2-Hexanediol, Beta-Glucan, Bifida Ferment Lysate, Scutellaria Baicalensis Root Extract, Illicium Verum (Anise) Fruit Extract, Arginine, Carbomer, Gentiana Scabra Root Extract, Cynara Scolymus (Artichoke) Bud Extract, Pteris Multifida Extract, Camellia Sinensis Leaf Extract, Luffa Cylindrica Fruit Extract, Allium Sativum (Garlic) Bulb Extract, Psidium Guajava Leaf Extract, Psidium Guajava Fruit Extract, Foeniculum Vulgare (Fennel) Leaf Extract, Momordica Charantia Extract, Spirulina Platensis Extract, Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Selaginella Tamariscina Extract, Gynostemma Pentaphyllum Extract, Sodium Hyaluronate, Dioscorea Japonica Root Extract, Hydrolyzed Corn Starch, Allantoin, Betaine, Sucrose

PURPOSE

OTC - PURPOSE SECTION

Skin Brightening, Anti Wrinkle

WARNINGS

WARNINGS SECTION

Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear and consult with the dermatologist if symptoms persist.
Do not use on wounds, animal bites or serious burn.
Keep out of reach of children.
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

■ This solution controls forming wrinkle with Korea patented cosmetic composition “RealTox”.
■ Helps improve the brightness skin tone
■ Helps reduce the appearance of fine lines and wrinkles

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply the adequate amount on face and cover up face with hands to be absorbed

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
72729-030-022023-01-30C16284748780-1f386c649-e72d-0266-e053-dadaa90a7c1af96eb0ae-67dd-4f3b-8e0b-36402dc1cfdc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72729-030-01reFACE TOX AMPULE3.5 mL in 1 CONTAINERSOLUTION3.52
72729-030-02reFACE TOX AMPULE4 in 1 CARTONSOLUTION42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72729-030REFACE TOX AMPULE (NIACINAMIDE, ADENOSINE) SOLUTION [WOORHI MECHATRONICS CO., LTD.]2Legacy NDC, 2 package rows20210629_f96eb0ae-67dd-4f3b-8e0b-36402dc1cfdc.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
72729-03072729-030-01, 72729-030-02

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
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
548f7104-e758-40da-bf29-d50b91c17e9ff96eb0ae-67dd-4f3b-8e0b-36402dc1cfdc2021-06-28WarningsExact identifier
spl id: 548f7104-e758-40da-bf29-d50b91c17e9f
spl set id: f96eb0ae-67dd-4f3b-8e0b-36402dc1cfdc

Reported adverse events (FAERS/openFDA)#

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