OILY HAIR DANDRUFF ZERRAN INTERNATIONAL (ZINC PYRITHIONE) CREAM [ZERRAN INTERNATIONAL CORPORATION]

OILY HAIR DANDRUFF ZERRAN INTERNATIONAL (ZINC PYRITHIONE) CREAM [ZERRAN INTERNATIONAL CORPORATION]
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NDC 38755-0111-1, 38755-0111-2
Set ID a14b85c2-8327-455c-9c14-309eefb98aed
Category HUMAN OTC DRUG LABEL
Packager Zerran International Corporation
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Drug Facts                               Purpose

    Zinc Pyrithione 1%              Anti-Dandruff

    helps prevent flaking and itching associated with dandruff

    Keep out of reach of children
    -if swallowed, get medical help or contact a Poison Control Center right away.

    -for external use only

    When using this product
    -avoid contact with eyes. If contact occurs rinse thoroughly with water

    Stop use and ask a doctor if
    -condition worsens or does not improve after regular use of this product as directed

    -For best results use every time you shampoo.

    -Wet hair, apply shampoo, then rinse.

    -For best results apply at least twice a week

    Inactive Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Lauryl Dimethylamie Oxide, Magnesium Aluminum Silicate, Hydrolyzed Soy Protein, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil, Coffea Arabica (Coffee) Seed Extract, Panthenol, Oat Amino Acids, Extracts of: Chamomilla Recutita (Matricaria) Flower, Citrus Aurantium Dulcis (Orange) Peel, Althea Officinalis, Achillea Millefolium, Foeniculum Vulgare (Fennel) Fruit, Glycyrrhiza Glabra (Licorice) Root, Ginkgo Biloba Leaf, Glycerin, Sorbic Acid, Citric Acid, Disodium EDTA, Methylisothiazolinone, Sodium Chloride, Blue 1, Yellow 5


    Image of back label


  • PRINCIPAL DISPLAY PANEL

    Zerran Hair Care
    Oily Hair Dandruff Shampoo
    33.81 fl.oz./1 Liter

    8fl. oz./240 ml

    Image of Front Label

  • INGREDIENTS AND APPEARANCE
    OILY HAIR DANDRUFF   ZERRAN INTERNATIONAL
    zinc pyrithione cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:38755-0111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    BITTER FENNEL (UNII: J5W36Y5WG8)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBIC ACID (UNII: X045WJ989B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:38755-0111-1240 mL in 1 BOTTLE
    2NDC:38755-0111-21000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/15/2010
    Labeler - Zerran International Corporation (175106392)
    Registrant - Cosmetic Enterprises Ltd. (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd. 017701475manufacture

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