Label: STERILE WATER injection

  • NDC Code(s): 65207-808-25, 65207-808-50, 65207-808-60
  • Packager: Nova-Tech, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 12, 2020

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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 After a quantity has been withdrawn for use the remainder should be discarded.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

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801 USA

    18-808

    RMS 92-356

    Assembled in USA

    Lot No.

    Exp. Date

  • GENERAL PRECAUTIONS

    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 preservatives; solutions made from this water should be used promptly.

  • STORAGE AND HANDLING

    Store between 15°C - 30°C (59°F - 86°F)

  • PRINCIPAL DISPLAY PANEL

    500 mL Label250 mL Label1000 mL Label

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-808
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1000 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65207-808-601000 mL in 1 BOTTLE, PLASTIC
    2NDC:65207-808-50500 mL in 1 BOTTLE, PLASTIC
    3NDC:65207-808-25250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/21/2019
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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