Drug Labeling and Warnings

Drug Details [pdf]

MADECA DERMA ULTRA MOISTURE HYDROGE L MASK- niacinamide, adenosine patch 
Dongkook Pharmaceutical 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.

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ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Dipropylene Glycol, Caprylic/Capric Triglyceride, Ceratonia Siliqua Gum, Chondrus Crispus Powder, Cetyl Ethylhexanoate, Glyceryl Stearate, Butylene Glycol, Paeonia Suffruticosa Root Extract, Centella Asiatica Extract, Cellulose Gum, 1,2-Hexanediol, Polyacrylate-13, Chamomilla Recutita (Matricaria) Flower Extract, Tillandsia Usneoides Extract, Glyceryl Caprylate, Polyisobutene, Polysorbate 20, Allantoin, Hydrogenated Vegetable Oil, Butyrospermum Parkii (Shea) Butter, Ethylhexylglycerin, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Methylglucose Distearate, Water(Onsen-Sui), Water(Carbonated Water), Water (Glacier Water), Asiaticoside , Asiatic Acid, Madecassic Acid, Sorbitan Sesquioleate, Carbomer, Potassium Hydroxide, Oenothera Biennis (Evening Primrose) Oil, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Fragrance

PURPOSE

Purpose: Skin Brightening & Anti wrinkle

WARNINGS

Warnings: 1. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 2. Use with caution if you are highly sensitive to any bandages or wet compresses. 3. Do not use the product on an open skin wound or on areas of eczema or infection. 4. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 5. Storage and handling instructions 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: 100% cellulose sheet mask promotes even absorption into the skin to help improve wrinkles.

Direction

Direction: 1. After cleansing your face, apply skin toner. 2. Take the product out of the package and adhere it evenly over your face avoiding the eye and mouth area. 3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining product into the skin until thoroughly absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MADECA DERMA ULTRA MOISTURE HYDROGE L MASK 
niacinamide, adenosine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70541-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.6 g  in 30 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.01 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70541-050-0210 in 1 CARTON10/01/201710/16/2019
1NDC: 70541-050-0130 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/201710/16/2019
Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
Establishment
NameAddressID/FEIBusiness Operations
Imine Co., Ltd.557816813manufacture(70541-050)

Revised: 12/2018
 
Dongkook Pharmaceutical Co., Ltd.