Label: VETERINARY STERILE WATER- sterile water injection

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

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Drug Label Information

Updated May 11, 2018

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  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

  • Indications

    Veterinary Sterile Water for Injection is suitable for use as a diluent for the preparation of pharmaceutical solutions

  • 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 1

     Veterinary Sterile Water for Injection, USP
     Size (mL) 1000
     Osmolarity (mOsmol/L) (calc) 0
     pH 5.5 (5.0 to 7.0)

  • Contraindications:

    None known

  • Warnings

    This solution is not isotonic and is hemolytic.

  • Dosage and administration:

    As directed by a veterinarian.

  • Cautions

    Sterile water for Injection is not suitable for intravascular injection without first having been made isotonic by addition of suitable solutes. Do not use unless solution is clear and seal is intact. Discard unused portion.

  • How Supplied:

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

     NDC Code Size (mL) Product Name
     86094-891-01 1000 Sterile Water For Injection, USP

    Plastic Container:PVC Free, DEHP Free, Latex Free. The volumetric scales on the single dose plastic container should only be used as a reference. For precise dosage of volumes it is recommeded the use of IV Infusion pump or IV Burrette.

  • 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 process may be observed. This is normal and does not affect the solution quality or 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

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    Manufactured for:

    IVALI LLC
    18205 Biscayne Blvd., Suite 2202
    Aventura Florida

    Printed in Argentina
    For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call IVALI LLC. Customer service at 1-305-692-7665
    IVALI is a trademark of IVALI LLC., all rights reserved.
    © 2018 IVALI LLC.

  • Principal Display Panel

    NDC 86094-891-01

    IVALI

    Veterinary Sterile Water for Injection, USP

    1000 mL

    image description

  • INGREDIENTS AND APPEARANCE
    VETERINARY STERILE WATER  
    sterile water injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86094-891
    Route of AdministrationINTRAVENOUS
    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:86094-891-011000 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/11/2018
    Labeler - Ivali LLC (081136076)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS JAYOR S.R.L.979312485api manufacture, manufacture
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