FDA.reportPublic FDA data

Dr MEDECEAN Return Whitening Essence

Manufacturer
INNOGENE CO.,LTD
Effective date
2017-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:35

Label at a glance#

ProductDr MEDECEAN Return Whitening Essence
Active ingredientDimethicone, Allantoin
Label structure8 sections

Indications and uses

Uses: Dr.MEDECEAN Return Whitening Essence will return your skin to its original tone.

Dosage and administration

Directions: After using toner in the morning and evening, apply an appropriate amount evenly throughout the face.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Dimethicone 3.0%, Allantoin 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Propylheptyl Caprylate, Butylene Glycol, Pentylene Glycol, Sucrose Polystearate, Cetearyl Alcohol, Niacinamide, Beheneth-25, Undecane, Cetearyl Glucoside, BeesWax, Panthenol, Glycerin, Hydrogenated Polyisobutene, Disodium Stearoyl Glutamate, Sucrose, Tridecane, Sucrose Dilaurate, Mannitol, Xanthan Gum, Sodium Polyacrylate, Chlorphenesin, Serine, Arginine, Ammonium Glycyrrhizate, Escin, Citric Acid, PCA, Polysorbate 20, Ruscus Aculeatus Root Extract, Alanine, Sclerotium Gum, Pisum Sativum (pea) Extract, Centella Asiatica Extract, Threonine, Disodium EDTA, Caprylyl Glycol, Hydrolyzed Yeast Protein, Calendula Officinalis Flower Extract, Sodium Citrate, Caffeine, Zinc Gluconate, p-Anisic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Mourera Fluviatilis Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only

1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses: Dr.MEDECEAN Return Whitening Essence will return your skin to its original tone.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: After using toner in the morning and evening, apply an appropriate amount evenly throughout the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

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-138809405064387GTIN-13: 8809405064387
EAN-13: 8809405064387
GTIN storage (14 digits): 08809405064387		essence carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70540-050-022020-01-31C16284748780-19d75b9d0-6049-f424-e053-dadaa90a57ceb82dc1b0-b468-4bd6-a484-c11c7312042f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70540-050-01Dr MEDECEAN Return Whitening Essence40 g in 1 CONTAINERLIQUID401
70540-050-02Dr MEDECEAN Return Whitening Essence1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70540-050DR MEDECEAN RETURN WHITENING ESSENCE (DIMETHICONE, ALLANTOIN) LIQUID [INNOGENE CO.,LTD]1Legacy NDC, 2 package rows20170927_b82dc1b0-b468-4bd6-a484-c11c7312042f.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70540-05070540-050-01, 70540-050-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Allantoin344S277G0ZACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
ca1487c0-bc10-4581-9dd5-a1c91856dcfeb82dc1b0-b468-4bd6-a484-c11c7312042f2017-09-27WarningsExact identifier
spl id: ca1487c0-bc10-4581-9dd5-a1c91856dcfe
spl set id: b82dc1b0-b468-4bd6-a484-c11c7312042f

Reported adverse events (FAERS/openFDA)#

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