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Madeca Derma Intensive Vital

Medically reviewed by Drugs.com. Last updated on Dec 31, 2018.

Dosage form: cream
Ingredients: DIMETHICONE 0.58g in 50mL
Labeler: Dongkook Pharmaceutical Co., Ltd.
NDC Code: 70541-040

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.

ACTIVE INGREDIENT

Active ingredients: DIMETHICONE 1.16%

INACTIVE INGREDIENT

Inactive ingredients: CENTELLA ASIATICA EXTRACT, CYCLOPENTASILOXANE, ALCOHOL, GLYCERIN, METHYLPROPANEDIOL, CETEARYL ALCOHOL, HYDROGENATED POLY(C6-14 OLEFIN), WATER, NIACINAMIDE, PEG-100 HYDROGENATED CASTOR OIL, PHOSPHOLIPIDS, NEOPENTYL GLYCOL DIHEPTANOATE, POLYGLYCERYL-10 MYRISTATE, DIOSCOREA JAPONICA ROOT EXTRACT, GLYCERYL STEARATE, PEG-100 STEARATE, HYDROGENATED LECITHIN, BEHENYL ALCOHOL, BINDEREMULSION STAILIZERVISCOSITY INCREASING AGENT, 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, 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, POLYGLYCERYL-10 STEARATE, FRAGRANCE, HYDROGENATED STARCH HYDROLYSATE, TRISODIUM EDTA, RAFFINOSE, ADENOSINE, 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 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-S and naturally-derived ingredient provide nourishing moisture to help restore your skin’s natural vitality.

Direction

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADECA DERMA INTENSIVE VITAL 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.58 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
METHYLPROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:70541-040-021 TUBE in 1 CARTON
1NDC:70541-040-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201707/30/2019
Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
Establishment
NameAddressID/FEIOperations
Kolmar Korea Co., Ltd.689512611manufacture(70541-040)

 
Dongkook Pharmaceutical Co., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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