Label: STERILE WATER injection

  • NDC Code(s): 13985-808-25, 13985-808-50, 13985-808-60
  • Packager: MWI (VetOne)
  • 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 June 10, 2014

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

  • INDICATIONS:

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

  • CONTAINS:

    Water for Injection USP.............................100%

    This is a single dose vial.

    Contains no preservatives.

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by: MWI
    Boise, ID 83705
    (888) 694-8381
    www.vetone.net

    Rev. 05/12

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

    V1 501046

    Net Contents: 250 mL

    RMS 92-1011          18-808-25

    LOT NO.:       EXP. DATE:

  • VETERINARY INDICATIONS

    For use in animals only.

    Not for human use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets.

  • CAUTION:

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

  • CAUTION:

    Sterile water for Injection is not suitable for intravascular injection without first having been made isotonic by addition of suitable solutes. Do not use the product if the seal has been broken or if the solution is not clear.

  • STORAGE:

    Store at controlled temperature between 15 degrees C and 30 degrees C (59 degrees - 86 degrees F).

    Handle under strict aseptic conditions. Solutions made with this sterile water should be used promptly or sterilized to maintain quality. Discard any unused portion.

  • PRINCIPAL DISPLAY PANEL

    250 container label500 container label1000 container label

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-808
    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:13985-808-25250 mL in 1 BOTTLE, PLASTIC
    2NDC:13985-808-50500 mL in 1 BOTTLE, PLASTIC
    3NDC:13985-808-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/30/2012
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture