MADECA DERMA INTENSIVE VITAL CREA M- niacinamide, adenosine cream

Madeca Derma Intensive Vital by

Drug Labeling and Warnings

Madeca Derma Intensive Vital by is a Otc medication manufactured, distributed, or labeled by Dongkook Pharmaceutical Co., Ltd., Dongkook PharmaceuDongkook Pharmaceutical Co., Ltd.tical Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients:

Centella asiatica extract, Cyclopentasiloxane, Alcohol, Glycerin, Methylpropanediol, Cetearyl alcohol, Hydrogenated poly(C6-14 olefin), Neopentyl glycol diheptanoate, Water, PEG-100 hydrogenated castor oil, Phospholipids, Polyglyceryl-10 myristate, Dioscorea japonica root extract, Glyceryl stearate, PEG-100 stearate, Hydrogenated lecithin, Behenyl alcohol, Hydrogenated polydecene, Phytosteryl/behenyl/octyldodecyl lauroyl glutamate, 1,2-hexanediol, Arctium lappa root extract, Phellinus linteus extract, Piper methysticum leaf/root/stem extract, Madecassic acid, Asiaticoside, Phenoxyethanol, Pentylene glycol, Asiatic acid, Squalane, Dimethicone, Hydrogenated polyisobutene, Caprylyl glycol, Betaine, Ethylhexylglycerin, Polyquaternium-51, Rubus chamaemorus seed extract, Tocopheryl acetate, Myrciaria dubia fruit extract, Glycosyl trehalose, Butylene glycol, Argania spinosa kernel oil, Isononyl isononanoate, Polyglyceryl-10 stearate, Fragrance, Hydrogenated starch hydrolysate, Trisodium EDTA, Raffinose, Biosaccharide gum-1, Butyrospermum parkii (shea) butter, Polyglyceryl-2 dipolyhydroxystearate, Stearic acid, Arginine, Lecithin, Xanthan gum, PVM/MA copolymer, Sodium hyaluronate, Sodium lauroyl lactylate, Sodium polyacrylate, Inulin lauryl carbamate, Sorbitan laurate, Ceramide NP, Folic acid, Cholesterol, Disodium stearoyl glutamate, Hydrolyzed hyaluronic acid, Hydrolyzed lupine protein, Hydroxyethylcellulose, Ceramide AP, Phytosphingosine, Carbomer, Tromethamine, Maltodextrin, Hydrolyzed vegetable protein, Saccharide hydrolysate, Ceramide EOP, Panthenol, Acetyl dipeptide-1 cetyl ester, Palmitoyl tripeptide-5, Acetyl hexapeptide-8, Palmitoyl pentapeptide-4

PURPOSE

Purpose: Skin Brightening, Anti Wrinkle

WARNINGS

Warnings:

1.For external use only. 2. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 3. Use with caution if you are highly sensitive to any bandages or wet compresses. 4. Do not use the product on an open skin wound or on areas of eczema or infection. 5. 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. 6. 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:

TECA-S and naturally-derived ingredients provide nourishing moisture to help restore your skin’s natural vitality.

Direction

Directions:

Softly apply cream along the skin and pat gently for better absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MADECA DERMA INTENSIVE VITAL  CREA M
niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70541-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	1 g  in 50 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.02 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70541-070-02	1 in 1 CARTON	05/01/2018	01/01/2021
1	NDC: 70541-070-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2018	01/01/2021

Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)

Registrant - Dongkook PharmaceuDongkook Pharmaceutical Co., Ltd.tical Co., Ltd. (688003495)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70541-070)