Label: ZARAZYL- barrier cream cream

  • NDC Code(s): 86107-001-01
  • Packager: Dara Craiceann Limited
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 19, 2021

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  • PRECAUTIONS

    For external use only.
    For equine animal use only.
    Store in cool dry conditions.
    Keep out of reach of children.
    Not for use in Horses intended for food.

  • INSTRUCTIONS FOR USE

    Clean and dry affected area before use. Apply cream liberally once or twice daily.   

  • PRINCIPAL DISPLAY PANEL

    Package Label 08 Aug 2019.jpg

    Package Label

  • INGREDIENTS AND APPEARANCE
    ZARAZYL 
    barrier cream cream
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86107-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (ORTHOSILICIC ACID - UNII:623B93YABH) ORTHOSILICIC ACID0.074 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    Colorwhite (white/off white cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86107-001-01200 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/12/2019
    Labeler - Dara Craiceann Limited (985720091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dara Craiceann Limited985720091label
    Establishment
    NameAddressID/FEIBusiness Operations
    Ovelle Ltd.219542784api manufacture, manufacture
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