FDA.reportPublic FDA data

WF FACE FITNESS BTX COLLAGEN SOOTHING

Manufacturer
GTG Wellness Co., Ltd. | Hansol Bio Co.,Ltd
Effective date
2020-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:14

Label at a glance#

ProductWF FACE FITNESS BTX COLLAGEN SOOTHING
Active ingredientNiacinamide, Adenosine
Label structure8 sections

Indications and uses

Uses: Helps brighten skin tone. Helps improve wrinkle problem.

Dosage and administration

Directions: Apply enough amount of the product gently on your skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Niacinamide 2.00%, Adenosine 0.04%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, Glycerin, PEG-8, 1,2-Hexanediol, Butylene Glycol, Propanediol, Erythritol, Trehalose, Bacillus Ferment, Portulaca Oleracea Extract, Centella Asiatica Leaf Water, Ilex Paraguariensis Leaf Extract, Chenopodium Quinoa Seed Extract, Glutamic Acid, Glycine, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Acetyl Hexapeptide-8, Copper Tripeptide-1, Palmitoyl Pentapeptide-4, rh-Oligopeptide-1, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Tromethamine, Allantoin, Hydrolyzed Collagen, Polyglyceryl-10 Laurate, Disodium EDTA, Dipotassium Glycyrrhizate, PEG-40 Hydrogenated Castor Oil, Caprylyl Glycol, PPG-26-Buteth-26, Ethylhexylglycerin, Fragrance

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Brightening, Anti wrinkle

WARNINGS

WARNINGS SECTION

Warnings:

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.
2. Do not use on wounded areas.
3. Precautions for storage and handling
a) Keep out of reach of children.
b) Avoid 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

Uses:

Helps brighten skin tone.
Helps improve wrinkle problem.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply enough amount of the product gently on your skin.

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
71080-0014-22022-07-29C16284748780-1e4f33bdf-ad2f-d8a0-e053-dadaa90a6e4edd845925-27db-4cfb-8b31-2d630136de60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71080-0014-1WF FACE FITNESS BTX COLLAGEN SOOTHING50 mL in 1 CONTAINERGEL501
71080-0014-2WF FACE FITNESS BTX COLLAGEN SOOTHING1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71080-0014WF FACE FITNESS BTX COLLAGEN SOOTHING (NIACINAMIDE, ADENOSINE) GEL [GTG WELLNESS CO., LTD.]1Legacy NDC, 2 package rows20200327_dd845925-27db-4cfb-8b31-2d630136de60.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
71080-001471080-0014-1, 71080-0014-2

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
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT

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
1fd79dd5-5c0e-447c-a689-d9b3e0765519dd845925-27db-4cfb-8b31-2d630136de602020-03-24WarningsExact identifier
spl id: 1fd79dd5-5c0e-447c-a689-d9b3e0765519
spl set id: dd845925-27db-4cfb-8b31-2d630136de60

Reported adverse events (FAERS/openFDA)#

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