MEDI WRINKLE CREAM- dimethicone cream 
MICELL KOREA 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

Dimethicone (1%) - Skin Protectact
Allantoin (0.01%) - Skin Protectact

INACTIVE INGREDIENT

Water, Butylene Glycol, Glycerin, Cetyl 2-Ethylhexanoate , Niacinamide, Sodium Hyaluronate, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexandiol, Hydroxyethylethylcelluose, Cetearyl Glucoside, Sorbitan Olivate, Cetearyl Alcohol, Niacinamide, Sodium Hyaluronate, Stearic acid, Propylene Glycol, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCl, Maltodextrin / Sodium Starch Octenylsuccinate, Cetearyl Alcohol, Argania Spinosa Kernel Oil, Orbignya Oleifera Seed Oil, Tocopherol, Camellia Sinensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavendula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hydrolyzed Collagen,Hydrogenated Lecithin, Ceramide NP, PEG-10 Rapeseed sterol, Dipropylene Glycol, Glyceryl Stearate, Glycereth-20, Beeswax, Carthamus Tinctorius (Safflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olus (Vegetable) Oil, Tocopherol, Macadamia Integrifolia Seed Oil, Octanediol, Ethylhexylglycerin, Citrus grandis (grapefruit) seed extract, Artemisia princeps extract, Carbomer, Triethanolamine, Caprylyl Glycol, PPG-26 Buteth-26, PEG-40 Hydrogenated Caster oil, Alcohol, Phenoxyethanol, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Copper Tripeptide-1, Fragrance, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Xanthan Gum, Adenosine, Disodium EDTA

PURPOSE

Skin Protectact

WARNINGS

For skin use only.
Do not use
 on puncture wounds  on animal bites  on serious burns  on area with scratches, eczema, or dermatitis
When using this product
 avoid contact with eyes
Stop use and ask a doctor if
 you have allergy or skin disease
 rash or irritation develops and lasts
 red spots, swelling, itching, irritation and other abnormalities develops

KEEP OUT OF REACH OF CHILDREN

 if swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

 Clean skin thorounghly before using
 After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
 Use it every days in the evening according to skin condition

DOSAGE & ADMINISTRATION

 Clean skin thorounghly before using
 After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
 Use it every days in the evening according to skin condition

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

MEDI WRINKLE CREAM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71327-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.0021 g  in 210 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.000021 g  in 210 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Methionine (UNII: AE28F7PNPL)  
Serine (UNII: 452VLY9402)  
Histidine (UNII: 4QD397987E)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71327-004-01210 mL in 1 PACKAGE; Type 0: Not a Combination Product03/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/2017
Labeler - MICELL KOREA CO.,LTD (689851542)
Registrant - MICELL KOREA CO.,LTD (689851542)
Establishment
NameAddressID/FEIBusiness Operations
MICELL KOREA CO.,LTD689851542manufacture(71327-004)

Revised: 3/2017
Document Id: 8e646b4b-e7e4-4a0f-8259-a040cdf55e78
Set id: 16a84e78-8a26-4c8f-8392-189120248f45
Version: 2
Effective Time: 20170323
 
MICELL KOREA CO.,LTD