Drug Labeling and Warnings

Drug Details [pdf]

MADECA DERMA TIME REVERSE VITALIZING NIGHT MASK- dimethicone cream 
Dongkook Pharmaceutical Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: DIMETHICONE 2.04%

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, ARCTIUM LAPPA ROOT EXTRACT, BISABOLOL, PHELLINUS LINTEUS EXTRACT, HYDROGENATED LECITHIN, RAFFINOSE, SODIUM HYALURONATE, PANTHENOL, PENTYLENE GLYCOL, DIOSCOREA JAPONICA ROOT EXTRACT, MAGNESIUM ALUMINUM SILICATE, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, TOCOPHERYL ACETATE, 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, PROPOLIS EXTRACT, ADENOSINE, 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, 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: Skin Protectant

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

Direction

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADECA DERMA TIME REVERSE VITALIZING NIGHT MASK 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70541-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.02 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70541-060-02	1 in 1 CARTON	10/01/2017	10/15/2019
1	NDC: 70541-060-01	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
OTC monograph final	part347	10/01/2017	10/15/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70541-060)

Revised: 12/2018

Document Id: 7e538b40-02cb-09b5-e053-2991aa0af4d1

34390-5

Set id: 7fa4f99d-f1df-443c-b095-9508edae649d

Version: 2

Effective Time: 20181231