FDA.reportPublic FDA data

Medi Wrinkle Cream

Manufacturer
MICELL KOREA CO.,LTD
Effective date
2017-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:21

Label at a glance#

ProductMedi Wrinkle Cream
Active ingredientDimethicone, Allantoin
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Skin Protectact

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

 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

DOSAGE & ADMINISTRATION SECTION

 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 descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809494580973GTIN-13: 8809494580973
EAN-13: 8809494580973
GTIN storage (14 digits): 08809494580973		PACKAGE LABEL. PRINCIPAL DISPLAY PANEL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71327-004-012020-01-31C16284748780-19d75b9d1-049e-f424-e053-dadaa90a57ce16a84e78-8a26-4c8f-8392-189120248f45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71327-004-01Medi Wrinkle Cream210 mL in 1 PACKAGECREAM2102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71327-004MEDI WRINKLE CREAM (DIMETHICONE) CREAM [MICELL KOREA CO.,LTD]2Legacy NDC, 1 package rows20170323_16a84e78-8a26-4c8f-8392-189120248f45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71327-00471327-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Allantoin344S277G0ZACTIB
Water059QF0KO0RIACT
MethionineAE28F7PNPLIACT
Serine452VLY9402IACT
Histidine4QD397987EIACT
Butylene Glycol3XUS85K0RAIACT
Propylene Glycol6DC9Q167V3IACT
Maltodextrin7CVR7L4A2DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8e646b4b-e7e4-4a0f-8259-a040cdf55e7816a84e78-8a26-4c8f-8392-189120248f452017-03-23WarningsExact identifier
spl id: 8e646b4b-e7e4-4a0f-8259-a040cdf55e78
spl set id: 16a84e78-8a26-4c8f-8392-189120248f45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.