MADECA DERMA TIME REVERSE VITALIZING NIGHT MASK- adenosine cream 
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: Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients:

Centella asiatica extract, Polyglycerin-3, Glycerin, Hydrogenated poly(C6-14 olefin), 1,2-hexanediol, Water, Caprylic/capric triglyceride, Vegetable oil, Betaine, Cetearyl olivate, Methylpropanediol, Sorbitan olivate, Dimethicone, Arctium lappa root extract, Bisabolol, Phellinus linteus extract, Hydrogenated lecithin, Sodium hyaluronate, Panthenol, Pentylene glycol, Dioscorea japonica root extract, Piper methysticum leaf/root/stem extract, Caprylyl glycol, Ethylhexylglycerin, Fragrance, Tocopheryl acetate, Propolis extract, Aloe barbadensis leaf extract, Centella asiatica callus extract, Hibiscus esculentus fruit extract, Lavandula angustifolia (lavender) extract, Linum usitatissimum (linseed) seed extract, Rubus chamaemorus seed extract, Tillandsia usneoides extract, Berberis vulgaris root extract, Chamomilla recutita (matricaria) flower extract, Echinacea angustifolia extract, Rosmarinus officinalis (rosemary) leaf extract, Hydrogenated polyisobutene, Squalane, Disodium EDTA, PVM/MA copolymer, Alcohol, Polyquaternium-51, Glycosyl trehalose, Argania spinosa kernel oil, Isononyl isononanoate, Polyglyceryl-10 stearate, Sodium polyacrylate, Cetearyl alcohol, Glyceryl stearate, PEG-100 stearate, Polysorbate 60, Magnesium aluminum silicate, Raffinose, Hydrogenated starch hydrolysate, Biosaccharide gum-1, Butyrospermum parkii (shea) butter, Oenothera biennis (evening primrose) oil, Polyglyceryl-2 dipolyhydroxystearate, Stearic acid, Butylene glycol, Phospholipids, Lecithin, Folic acid, Inulin lauryl carbamate, Asiaticoside, Ceramide NP, Cholesterol, Asiatic acid, Disodium stearoyl glutamate, Tromethamine, Madecassic acid, Palmitoyl pentapeptide-4

PURPOSE

Purpose: 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 provides rich nutrient and moisture leaving your skin refreshed and revitalized.

Direction

Directions:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MADECA DERMA TIME REVERSE VITALIZING NIGHT  MASK
adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.02 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70541-080-021 in 1 CARTON05/01/201810/05/2020
1NDC:70541-080-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/201810/05/2020
Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
Registrant - Dongkook PharmaceuDongkook Pharmaceutical Co., Ltd.tical Co., Ltd. (688003495)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(70541-080)

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