ReFACE TOX AMPULE: Package Insert and Label Information

REFACE TOX AMPULE- niacinamide and adenosine solution
Woorhi Mechatronics Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENTS

Niacinamide 2.0%, Adenosine 0.04%

INACTIVE INGREDIENTS

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

Skin Brightening, Anti Wrinkle

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REFACE TOX AMPULE niacinamide, adenosine solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72729-030 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Niacinamide (NIACINAMIDE) Niacinamide 0.07 g in 3.5 mL Adenosine (ADENOSINE) Adenosine 0.001 g in 3.5 mL

Inactive Ingredients Ingredient Name Strength Water Butylene Glycol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72729-030-02 4 CONTAINER in 1 CARTON contains a CONTAINER (72729-030-01) 1 NDC:72729-030-01 3.5 mL in 1 CONTAINER This package is contained within the CARTON (72729-030-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2018

Labeler — Woorhi Mechatronics Co., Ltd. (557837985)

Registrant — Woorhi Mechatronics Co., Ltd. (557837985)

Establishment
Name	Address	ID/FEI	Operations
Ester Co., Ltd.		688425766	manufacture (72729-030)

Revised: 06/2021 Woorhi Mechatronics Co., Ltd.