Label: MANNITOL 20%- mannitol injection

  • 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 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 AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    RMS 92-384

    Made in the USA

    Item No. 09061

    NDC 59051-8061-5

    Mannitol Injection 20%

    Sterile Solution

    NeogenVet

    Net Contentes: 100 mL

    Lot No.

    Exp. Date:

    Neogen

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

    Manufactured for: Neogen Corporation, Lexington, KY 40511

    859-254-1221

    animalsafety.neogen.com

    L566-0518

  • WARNINGS AND PRECAUTIONS

    FOR ANIMAL USE ONLY

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

    KEEP OUT OF REACH OF CHILDREN

  • Mannitol Injection 20%

    Mannitol Injection 20%

  • INGREDIENTS AND APPEARANCE
    MANNITOL 20% 
    mannitol injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59051-8061
    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:59051-8061-5100 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/20/2011
    Labeler - Neogen Corporation (042125879)
    Registrant - Nova-Tech, Inc (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture