Label: 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 March 16, 2020

If you are a consumer or patient please visit this version.

  • Recommended Use:

    For use as an osmotic diuretic in dogs. 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.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    NDC:11695-1254-1

    Net contents: 100 mL (3.4 fl oz)

    Lot No.

    Exp. Date

    Reorder #002469

    Questions?

    (855) 724-3461

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Made in the USA

    AH-002469-02

    RMS-92-1192

    L919-1119

    REV: 1119

  • 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

  • PRINCIPAL DISPLAY PANEL

    100 mL Label

  • INGREDIENTS AND APPEARANCE
    MANNITOL 
    mannitol injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-1254
    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:11695-1254-1100 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/16/2020
    Labeler - Covetrus (603750329)
    Registrant - Nova-Tech, Inc (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture