Label: MANNITOL 20%- mannitol injection

  • 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 November 22, 2019

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  • INDICATIONS:

    Mannitol Injection 20% is indicated for use as an osmotic diuretic in canine species. Mannitol is essentially inert metabolically. When given parenterally, it is freely filtered at the glomerulus which produces osmotic diuresis as more than 90% of the mannitol injected escapes reabsorption.

  • Each 100 mL Contains:

    Mannitol USP...................................20 g

    Water for Injection...........................q.s.

    This solution contains 1098 m0smols/Liter

  • Dosage and Administration:

    The usual canine dosage administered intravenously is 1.5 - 2.0 g per Kg body weight given over a 30 minute period. This is approximately 3.4-4.5 mL/lb of body weight.

  • Note:

    Crystals of mannitol may form in a 20% saturated solution of mannitol. Dissolve the crystals by warming in hot water or autoclaving for 15 minutes. Cool to body temperature before administering. This is a single dose vial that contains no preservatives. Use entire contents when first opened.

  • Storage:

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

  • SPL UNCLASSIFIED SECTION

    NDC 13985-052-15

    100 mL

    Lot #

    Exp. Date

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

    Distributed by: 

    MWI

    Boise, ID 83705

    www.VetOne.net

    Made in USA

    V1 501050

    Net Contentes: 100 mL

    Rev. 05/18

    RMS-92-530

  • WARNINGS AND PRECAUTIONS

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

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

  • MANNITOL 20%

    Mannitol 20%

  • INGREDIENTS AND APPEARANCE
    MANNITOL 20% 
    mannitol injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-052
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-052-15100 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/20/2011
    Labeler - MWI (VetOne) (019926120)
    Registrant - Nova-Tech, Inc (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture