BALLVIC SEBO

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 22:45:28

Label at a glance#

ProductBALLVIC SEBO
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Dosage and administration

Directions: 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Zinc Pyrithione 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

DIRECTIONS

INDICATIONS & USAGE SECTION

Directions: 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-138809405060327GTIN-13: 8809405060327
EAN-13: 8809405060327
GTIN storage (14 digits): 08809405060327
ballvic sebo carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70540-020-012020-01-31C16284748780-19d75b9d0-0721-f424-e053-dadaa90a57ce313dcdb8-afed-4b97-891e-e14bfa5e5b1f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70540-020-01BALLVIC SEBO230 g in 1 CARTONSHAMPOO2301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70540-020BALLVIC SEBO (PYRITHIONE ZINC) SHAMPOO [INNOGENE CO.,LTD]1Legacy NDC, 1 package rows20160321_313dcdb8-afed-4b97-891e-e14bfa5e5b1f.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
70540-02070540-020-01

Ingredients#

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

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

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
cad7017a-d9c2-4799-a488-0356d7774356313dcdb8-afed-4b97-891e-e14bfa5e5b1f2016-03-21WarningsExact identifier
spl id: cad7017a-d9c2-4799-a488-0356d7774356
spl set id: 313dcdb8-afed-4b97-891e-e14bfa5e5b1f

Reported adverse events (FAERS/openFDA)#

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