Label: HYPERTONIC SALINE 7.2 % injection, solution

  • 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 January 15, 2020

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  • DESCRIPTION

    HYPERTONIC SALINE 7.2 %- hypertonic saline 7.2 % 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.

    Hypertonic Saline Solution 7.2%

    Sterile - Preservative Free

    KEEP OUT OF REACH OF CHILDREN

  • ACTIVE INGREDIENT

    Each 100 mL of sterile aqueous solution contains:


    Sodium Chloride.................................................7.2 g

    Milliequivalents per liter:

    Cations Sodium.......................................1232 mEq/L
    Anions Chloride......................................1232 mEq/L

    Total osmolarity is 2464 milliosmoles per litter.

  • INDICATION

    For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.

  • DOSAGE AND AND ADMINISTRATION

    50 to 100 mL per lb bodyweight. Warm to body temperature and administer slowly by intravenous or subcutaneous injection. The amount and rate of administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration.

  • CAUTION

    This product contains no preservatives. Do not use if solution is not clear. Use entire contents when first opened. Discard any unused solution.

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

  • STORAGE

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed By


    VEDCO, INC.

    St. Joseph, MO 64507

    Made in El Salvador

    Net Contents: 1000 mL

    TABLE
     CONTENTS NDC VINV #
     1000 mL 50989-884-17 VINV-EQUI-7HSS

  • PRINCIPAL DISPLAY PANEL

    NDC 50989-884-17

    ULTIGIENE

    TERMINALLY STERILIZED

    HYPERTONIC SALINE SOLUTION 7.2%

    NET CONTENTS: 1000 mL

    VEDCO

    FOR ANIMAL USE 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

  • INGREDIENTS AND APPEARANCE
    HYPERTONIC SALINE 7.2 % 
    hypertonic saline 7.2 % injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-884
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE7.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50989-884-171000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2019
    Labeler - Vedco (021634266)
    Registrant - Vedco (021634266)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Biogalenic851259507manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S Minerals and Agriculture GmbH507531213api manufacture