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BALLVIC SEBO

Medically reviewed on March 21, 2018

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 2.3g in 230g
Labeler: INNOGENE CO.,LTD
NDC Code: 70540-020

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Active Ingredient: Zinc Pyrithione 1.0%

INACTIVE INGREDIENT

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

Purpose: Antidandruff

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

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: Take 5g of this product for one use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BALLVIC SEBO 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70540-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC2.3 g  in 230 g
Inactive Ingredients
Ingredient NameStrength
Water 
Ammonium Lauryl Sulfate 
Packaging
#Item CodePackage Description
1NDC:70540-020-01230 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/01/2016
Labeler - INNOGENE CO.,LTD (688201056)
Registrant - INNOGENE CO.,LTD (688201056)
Establishment
NameAddressID/FEIOperations
INNOGENE CO.,LTD688201056manufacture(70540-020)

 
INNOGENE CO.,LTD

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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