FDA.reportPublic FDA data

MEDECEAN SEBORRHEA

Manufacturer
INNOGENE CO.,LTD
Effective date
2016-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:29

Label at a glance#

ProductMEDECEAN SEBORRHEA
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Zinc Pyrithione 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Sodium Laureth Sulfate, Water, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Dimethiconol, Cocamide DEA, Brassica Campestris (Rapeseed) Sterols, Glycol Distearate, Glycerin, Panthenol, SD Alcohol 40-B, Silicone Quaternium-1, Propylene Glycol, Salicylic Acid, Climbazole, TEA-Dodecylbenzenesulfonate, Cetearyl Alcohol, Ammonium Glycyrrhizate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Mannitol, Menthol, Zinc Gluconate, Caffeine, Polyquaternium-10, Hydrolyzed Yeast Protein, Allantoin, Niacinamide, Biotin, Pyridoxine HCL, Citric Acid, Guar Hydroxypropyltrimonium Chloride, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Hexamidine Diisethionate, Methylchloroisothiazolinone, Methylisothiazolinone

PURPOSE

OTC - PURPOSE SECTION

Purpose: Antidandruff

WARNINGS

WARNINGS SECTION

Warnings: 1. If the following conditions occur, you must stop using immediately. Continuous use will make the conditions worsen. Consult your dermatologist. a. Red swellings such as erythema, itchiness, or irritations. b. When directly sunlight causes the conditions mentioned above. 2. Do not apply on skin conditions such as wounds, eczema, ordermatitis. 3. Storage and Handling. a. Make sure to close the cap after use. b. Keep out of the reach of children. c. Avoid low temperature, high temperature, or direct sunlight. 4. When in eyes, wash immediately. 5. Not washing thoroughly after shampooing may cause hair loss or change in color. Make sure to wash thoroughly after use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: Shampoo daily, massage your wel scalp and hair and leave on for 5 minutes before rinsing. BallVic Solution is recommended after you dry your hair.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Take 5g of this product for one use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809405063045GTIN-13: 8809405063045
EAN-13: 8809405063045
GTIN storage (14 digits): 08809405063045		medecean seborrhea carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70540-010-012020-01-31C16284748780-19d75b9d0-8b1e-f424-e053-dadaa90a57cec2870eb0-34c7-46c8-b983-a2fa37f9b443

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70540-010-01MEDECEAN SEBORRHEA300 g in 1 CARTONSHAMPOO3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70540-010MEDECEAN SEBORRHEA (PYRITHIONE ZINC) SHAMPOO [INNOGENE CO.,LTD]1Legacy NDC, 1 package rows20160321_c2870eb0-34c7-46c8-b983-a2fa37f9b443.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70540-01070540-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
Water059QF0KO0RIACT
Ammonium Lauryl SulfateQ7AO2R1M0BIACT

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
0cbd73f2-6294-42d8-8fd9-80c78395d518c2870eb0-34c7-46c8-b983-a2fa37f9b4432016-03-21WarningsExact identifier
spl id: 0cbd73f2-6294-42d8-8fd9-80c78395d518
spl set id: c2870eb0-34c7-46c8-b983-a2fa37f9b443

Reported adverse events (FAERS/openFDA)#

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