Label: STERILE SALINE injection, solution

  • NDC Code(s): 50989-885-15, 50989-885-16, 50989-885-17
  • Packager: Vedco
  • 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 March 12, 2019

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  • SPL UNCLASSIFIED SECTION

    STERILE SALINE- sterile saline injection, solution


    Vedco

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


    NORMAL SALINE SOLUTION

    FOR ANIMAL USE ONLY

    SOLD TO VETERINARIANS ONLY

  • Active Ingredient

    Each 100 mL contains:
    Sodium Chloride ....... 0.9 grams
    Water For Injection .............q.s.


    Milliequivalents per liter

    Cations
    Sodium .................... 154 mEq/L

    Anions
    Chloride ................... 154 mEq/L

    Total osmolarity is 308 milliosmoles per liter

  • WARNING:

    Do not use if solution is not clear or if seal is broken or damaged.

    This is a sterile, single use vial. Contains no bacteriostat.

    If entire contents are not used whenfirst opened, discard unused portion. Avoid warming to temperatures in excess of 150°F.

  • STORAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • CAUTION:

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

  • INDICATIONS:

    For use as a sterile diluent or solvent for veterinary pharmaceuticals and biologicals, and for the preparation of dilute solutions for intravenous infusion or local application.

  • DOSAGE

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed By


    VEDCO, INC.

    St. Joseph, MO 64507
    Made in El Salvador

    STERILE SOLUTION

    TABLE
     CONTENT NDC VINV #
     250 mL 50989-885-15 VINV-SALN-250M
     500 mL 50989-885-16 VINV-SALN-500M
     1000 mL 50989-885-17 VINV-SALN-1000

  • PRINCIPAL DISPLAY PANEL

    NDC 50989-885-15

    ULTIGIENE TERMINALLY STERILIZED

    NORMAL SALINE SOLUTION

    NET CONTENTS: 250 mL

    VEDCO

    SOLD TO VETERINARIANS ONLY

    KEEP OUT OF REACH OF CHILDREN

    CAUTION: Federal Law (U.S.A) restricts this drug to use by or on the order of a licensed veterinarian

    Label

    NDC 50989-885-16

    ULTIGIENE TERMINALLY STERILIZED

    NORMAL SALINE SOLUTION

    NET CONTENTS: 500 mL

    VEDCO

    SOLD TO VETERINARIANS ONLY

    KEEP OUT OF REACH OF CHILDREN

    CAUTION: Federal Law (U.S.A) restricts this drug to use by or on the order of a licensed veterinarian

    Label 1

    NDC 50989-885-17

    ULTIGIENE TERMINALLY STERILIZED

    NORMAL SALINE SOLUTION

    NET CONTENTS: 1000 mL

    VEDCO

    SOLD TO VETERINARIANS ONLY

    KEEP OUT OF REACH OF CHILDREN

    CAUTION: Federal Law (U.S.A) restricts this drug to use by or on the order of a licensed veterinarian

    Label 2

  • INGREDIENTS AND APPEARANCE
    STERILE SALINE 
    sterile saline injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-885
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50989-885-171000 mL in 1 BOTTLE, PLASTIC
    2NDC:50989-885-16500 mL in 1 BOTTLE, PLASTIC
    3NDC:50989-885-15250 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)
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