BALLVIC SEBO (PYRITHIONE ZINC) SHAMPOO [INNOGENE CO.,LTD]

BALLVIC SEBO (PYRITHIONE ZINC) SHAMPOO [INNOGENE CO.,LTD]
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NDC 70540-020-01
Set ID 313dcdb8-afed-4b97-891e-e14bfa5e5b1f
Category HUMAN OTC DRUG LABEL
Packager INNOGENE CO.,LTD
Generic Name
Product Class
Product Number
Application Number PART358H
  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BALLVIC SEBO 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70540-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.3 g  in 230 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70540-020-01230 g in 1 CARTON; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    INNOGENE CO.,LTD688201056manufacture(70540-020)

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