H ALPHA 30 Skin: Package Insert and Label Information

H 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, Betaine, Caprylhydroxamic Acid, 1,2-Hexanediol, Allantoin, Portulaca Oleracea Extract, Sigesbeckia Orientalis Extract, Panax Ginseng Root Extract, Ganoderma Lucidum (Mushroom) Extract, Polygonum Cuspidatum Root Extract, Lycium Chinense Fruit Extract, Rosmarinus Officinalis (Rosemary) Extract, Selaginella Tamariscina Extract, Yeast Extract, Copper Tripeptide-1 Hydrolyzed Hyaluronic Acid

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 hyaluronic Acid serum provides moisturizing and high nutrition to dull skin with peptide

■ Helps moisturize dehydrated skin

■ Helps improve the brightness of 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

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H ALPHA 30 SKIN
niacinamide, adenosine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72729-010
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:72729-010-01 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 (72729-010)

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

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