Label: VETERINARY STERILE WATER FOR IRRIGATION- sterile water irrigant

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 16, 2017

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  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

  • Description

    Prepared by distillation. Contains no antimicrobial agents or other substance has been added. Discard unused portion. Sterile, nonpyrogenic. Osmolarity and pH are shown in Table 1:

    Table

  • Contraindications:

    None known

  • Warnings

    This solution is not isotonic and is hemolytic.

  • Dosage and administration:

    As directed by a veterinarian.

  • Cautions

    Warm to not more than (500C/1220F) for a maximum of 60 days. Discard unopened bottle after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion.

  • How Supplied:

    Veterinary Sterile Water for Irrigation, USP in plastic container is available as follows:


    How Supplied Section



    Plastic Container:
    PVC Free, DEHP Free, Latex Free


  • Storage

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. it is recommended the product be stored in the moisture overwrap at room temperature (250C/770F), brief exposure up to (400C/1040F)does not adversely affect the product.

  • Directions for use of plastic container

    To Open

    Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization may be observed. this is normal and does not affect the solution quality or the safety. the opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

    Not for injection, for irrigation only.

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian

    Manufacture for:

    BrandImage


    Vedco, Inc.

    5503 Corporate Dr.

    St. Joseph, MO 64507 USA

    Printed in El Salvador

    For a copy of the Safety Data Sheet (MSDS) or to report adverse reaction call Vedco, Inc. customer service at 1(888)708-336

    © 2015 Vedco, Inc.

  • Principal Display Panel

    NDC 50989-894-17

    BIOGALENIC VEDCO

    Veterinary Sterile Water for Irrigation, USP

    Not for Injection - For Irrigation Only

    Label

  • INGREDIENTS AND APPEARANCE
    VETERINARY STERILE WATER FOR IRRIGATION 
    sterile water irrigant
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-894
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50989-894-171000 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/09/2016
    Labeler - Vedco, Inc. (021634266)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Biogalenic SA de CV851259507api manufacture, manufacture
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