Label: STERILE WATER- sterile water for injection injection

  • NDC Code(s): 46066-808-25, 46066-808-50, 46066-808-60
  • Packager: Aspen Veterinary
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 3, 2016

If you are a consumer or patient please visit this version.

  • 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    been withdrawn for use the remainder should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.

  • PRECAUTIONS

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

  • VETERINARY INDICATIONS

    For Animal Use Only

  • PRECAUTIONS

    Keep Out of Reach of Children

  • INFORMATION FOR OWNERS/CAREGIVERS

    NET CONTENTS:
    1000 mL (33.81 fl oz) 

  • INFORMATION FOR OWNERS/CAREGIVERS

    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 or sterilized with
    adequate precautions for maintaining sterility.

  • STORAGE AND HANDLING

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by:Aspen Veterinary Resources®, Ltd.Liberty, MO 64068 USA                           A253NT 07/15
    www.aspenaveterinaryresources.com 

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

    18-808
    RMS# 92-397

    Lot No.    Exp. Date

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    250 mL Container Label1000 mL Container Label500 mL Container Label

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water for injection injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-808
    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:46066-808-25250 mL in 1 BOTTLE, PLASTIC
    2NDC:46066-808-50500 mL in 1 BOTTLE, PLASTIC
    3NDC:46066-808-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/26/2013
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976api manufacture, manufacture