Label: SODIUM IODIDE 20%- sodium iodide 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 27, 2016

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

  • INDICATIONS:

    For use as an aid in the treatment of
    actinomycosis (lumpy jaw), actinobacillosis
    (wooden tongue) and necrotic stomatitis in
    cattle. 

  • CONTRAINDICATIONS:

    The use of sodium iodide is contraindicated in
    pregnancy and hyperthyroidism. 

  • DOSAGE AND ADMINISTRATION:

    Using aseptic procedures, administer slowly by
    intravenous injection. Inject carefully to avoid
    deposition ouside of the vein. The usual dose
    is 30 mg per pound of body weight (15 mL/100
    lb). May be repeated at weekly intervals, if
    necessary. 

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by:
    Aspen Veterinary Resources, Ltd.
    Liberty, MO 64068 USA              A247NT 05/15
    www.aspenveterinaryresources.com

    Manufactrued by:
    Nova-Tech, Inc.
    Grand Island, NE 68801 USA    18-819  RMS# 92-587

    NET CONTENTS:
    250 mL (8.45 fl oz)

    Lot No.    Exp. Date 

  • CAUTION:

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

  • VETERINARY INDICATIONS

    For Animal Use Only

  • WARNINGS

    Keep Out of Reach of Children

  • COMPOSITION:

    Each 100 mL of sterile aqueous solution
    contains:
    Sodium Iodide..............................20 grams
    Water for Injection................................q.s. 

  • WARNING:

    Not for use in lactating dairy cows.

  • CAUTION:

    Animals vary in their susceptibility of iodides.
    Administer with caution until the animal's
    tolerance is determined. Discontinue treatment
    if adverse reactions occur. 

  • STORAGE AND HANDLING

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

  • WARNINGS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    container label

  • INGREDIENTS AND APPEARANCE
    SODIUM IODIDE 20% 
    sodium iodide injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-819
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION20 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-819-25250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2015
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture, api manufacture