Label: ZARASYL COMPANION- barrier cream cream

  • NDC Code(s): 86107-002-01
  • Packager: Dara Craiceann Limited
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 27, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • PRECAUTIONS

    For external use only.
    For animal use only.

    Store in cool dry conditions.

    Keep out of reach of children.

    Not for use in animals intended for food.
    Do not use on deep or puncture wounds

    Discontinue use and consult your veterinarian if swelling, redness, irritation or excessive drainage develops at the site of application or if healing is delayed

  • INSTRUCTIONS FOR USE

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

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ZARASYL COMPANION 
    barrier cream cream
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86107-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (ORTHOSILICIC ACID - UNII:623B93YABH) ORTHOSILICIC ACID0.074 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    Colorwhite (white/off white cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86107-002-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/27/2022
    Labeler - Dara Craiceann Limited (985720091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dara Craiceann Limited985720091label
    Establishment
    NameAddressID/FEIBusiness Operations
    Ovelle Ltd.219542784manufacture, api manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!