Label: STERILE WATER- sterile water for injection injection

  • NDC Code(s): 50989-887-15, 50989-887-16, 50989-887-17
  • Packager: Vedco
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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 March 12, 2019

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  • SPL UNCLASSIFIED SECTION

    STERILE WATER- sterile water for injection injection


    Vedco

    Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

    STERILE WATER FOR INJECTION


    FOR ANIMAL USE ONLY

    SOLD TO VETERINARIANS ONLY

  • ACTIVE INGREDIENT

    Contains:


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

  • INDICATIONS:

    Sterile water for injection is intended for use as a sterile diluent for preparation of injectable solutions.

  • CAUTION:

    Sterile water for injection is not suitable for intravascular injection without first having been made isotonic by the addition of suitable solute.

  • STORAGE

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

  • VETERINARY INDICATIONS

    KEEP OUT OF REACH OF CHILDREN

  • CAUTION:

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

  • WARNING:

    Do not use this product if seal is broken or if solution is not clear. This is a sterile single dose vial. No preservatives have been added. Discard unused portion after use. Solutions made from this water should be used promptly or sterilized with adequate precautions for maintaining sterility.

  • DOSAGE & ADMINISTRATION

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed By


    VEDCO, INC.

    St. Joseph, MO 64507
    Made in El Salvador

    STERILE SOLUTION
     CONTENT NDC VINV #
     250 mL 50989-887-15 VINV-SH20-250M
     500 mL 50989-887-16 VINV-SH20-500M
     1000 mL 50989-887-17 VINV-SH20-1000

  • PRINCIPAL DISPLAY PANEL

    NDC 50989-887-15

    ULTIGIENE TERMINALLY STERILIZED

    STERILE WATER FOR INJECTION

    NET CONTENTS: 250 mL

    VEDCO

    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

    Label

    NDC 50989-887-16

    ULTIGIENE TERMINALLY STERILIZED

    STERILE WATER FOR INJECTION

    NET CONTENTS: 500 mL

    VEDCO

    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

    Label 1

    NDC 50989-887-17

    ULTIGIENE TERMINALLY STERILIZED

    STERILE WATER FOR INJECTION

    NET CONTENTS: 1000 mL

    VEDCO

    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

    Label 2

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water for injection injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-887
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50989-887-15250 mL in 1 BOTTLE, PLASTIC
    2NDC:50989-887-16500 mL in 1 BOTTLE, PLASTIC
    3NDC:50989-887-171000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2019
    Labeler - Vedco (021634266)
    Registrant - Vedco (021634266)