BALLVIC SEBO- pyrithione zinc shampoo

BALLVIC SEBO by

Drug Labeling and Warnings

BALLVIC SEBO by is a Otc medication manufactured, distributed, or labeled by INNOGENE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BALLVIC SEBO 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70540-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.3 g  in 230 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70540-020-01	230 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/01/2016

Labeler - INNOGENE CO.,LTD (688201056)

Registrant - INNOGENE CO.,LTD (688201056)

Establishment
Name	Address	ID/FEI	Business Operations
INNOGENE CO.,LTD		688201056	manufacture(70540-020)