Label: STERILE WATER injection

  • NDC Code(s): 11695-6403-2, 11695-6403-5
  • Packager: Covetrus
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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Drug Label Information

Updated December 2, 2019

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 After a quantity has been withdrawn for use the remainder should be discarded.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

  • 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:

    This sterile water for injection is made by
    reverse osmosis and deionization 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

    18-808

    RMS 92-526

    NDC: 11695-6403-2

    Sterile - nonpyrogenic

    Volume: 8.454 fl oz (250 mL)

    Questions? (855) 724-3461

    Reorder #069172

    Distributed by:
    Covetrus North America

    400 Metro Place North
    Dublin, OH 43017

    covetrus.com

    Manufactured by
    Nova-Tech, Inc.
    Grand Island, NE 68801

    Lot No.              

    Exp. Date

    Assembled in USA

    AH-069172-01

    REV: 0719 

  • PRINCIPAL DISPLAY PANEL

    250 ml500 ml

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-6403
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water500 mL  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-6403-5500 mL in 1 BOTTLE, PLASTIC
    2NDC:11695-6403-2250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/27/2011
    Labeler - Covetrus (603750329)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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