Label: MANNITOL 20%- mannitol injection

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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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 mOsmols/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 or resterilize by autoclaving.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

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

    Item No. 09061

    1072-022114

    Lot No.:

    Exp. Date

    NDC: 57319-521-05

    Mannitol Injection 20%

    Sterile Solution

    Net Contentes: 100 mL

    PhoenixTM

    Manufactured for:

    Clipper Distributing Company, LLC.

    St. Joseph, MO 64507

    Trademares are property of Clipper Distributing Company, LLC

  • WARNINGS AND PRECAUTIONS

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

    Take Time Observe Label Directions

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • MANNITOL 20%

    Mannitol 20%

  • INGREDIENTS AND APPEARANCE
    MANNITOL 20% 
    mannitol injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-521
    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:57319-521-05100 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/27/2011
    Labeler - Clipper (150711039)
    Registrant - Nova-Tech, Inc (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture
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