Label: 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 12, 2014

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  • CAUTION:

    Do not use this product if seal is broken or solution is not clear. Contains no preservative. If entire contents are not used, discard unused portion. Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly, and do not store.

  • CONTAINS:

    Water For Injection, USP.................100%

    This is a single dose vial. After a quantity has been withdrawn for use the remainder should be discarded.

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    RMS 92-542

    18-808-25

    Rev. 08-12

    Lot No.

    Exp. Date

  • GENERAL PRECAUTIONS

    Sterile-Nonpyrogenic

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • CAUTION:

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

  • INDICATIONS & USAGE

    This sterile water for injection is made by reverse osmosis and is suitable for use as a diluent for preparation of pharmaceutical solutions when made isotonic by addition of suitable solutes. This product contains no preservative; solutions made from this water should be used promptly or sterilized with adequate precautions for maintaining sterility.

  • STORAGE AND HANDLING

    Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by

    Nova-Tech, Inc.

    Grand Island, NE 68801

    Trademarks are property of Clipper Distributing Company, LLC

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-546
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER250 mL  in 250 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-546-06250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2012
    Labeler - Clipper (150711039)
    Registrant - Clipper (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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