OTC Medication Information: S ALPHA 30 Skin

S ALPHA 30 SKIN- 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 INGREDIENT

Active Ingredient: Niacinamide 2.0%, Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Sodium Hyaluronate, Glyceryl Polyacrylate, Caprylhydroxamic Acid, 1,2-Hexanediol, Panax Ginseng Callus Culture Extract, Daucus Carota Sativa (Carrot) Callus Culture Extract, Camellia Sinensis Callus Culture Extract, Chrysanthemum Indicum Callus Culture Extract, Phaseolus Radiatus Meristem Cell Culture Extract, Bambusa Vulgaris Callus Culture Extract, Citrus Reticulata (Tangerine) Peel Extract, Cucumis Melo (melon) Fruit Extract, Punica Granatum Fruit Juice, Aloe Barbadensis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Portulaca Oleracea Extract

PURPOSE

Purpose: Skin Brightening, Anti Wrinkle

WARNINGS

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

Uses:

■ This solution with plant callus culture extract provides moisturizing and high nutrition to dull skin with hyaluronic acid.

■ Helps reduce the appearance of fine lines and wrinkles

■ Helps improve writhe brightness skin tone

Directions

Directions:

After toner, apply the adequate amount on face and cover up face with hands to be absorbed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

S ALPHA 30 SKIN niacinamide, adenosine solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72729-020 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Niacinamide (NIACINAMIDE) Niacinamide 0.60 g in 30 mL Adenosine (ADENOSINE) Adenosine 0.012 g in 30 mL

Inactive Ingredients Ingredient Name Strength Water Butylene Glycol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72729-020-01 30 mL in 1 CARTON None

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 (72729-020)

Revised: 12/2018 Woorhi Mechatronics Co., Ltd.