Label: SODIUM IODIDE injection, solution

  • 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 August 22, 2019

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  • 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.

  • CAUTION

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

  • DOSAGE AND ADMINISTRATION:

    Using aspetic procedures, administer slowly
    by intravenous injection. Inject carefully to
    avoid deposition outside 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.

  • WARNING

    Not for use in lactating dairy cows.

  • VETERINARY INDICATIONS

    For Animal Use Only

  • WARNINGS

    Keep Out of Reach Of Children

  • CAUTION:

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

  • COMPOSITION

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

  • STORAGE AND HANDLING

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

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801 USA

    18-819

    RMS 92-366

    NDC# 65207-819-25

    Net Contents:

    250 mL (8.45 fl oz)

    Assembled in USA

    Lot No.

    Exp. Date

  • PRINCIPAL DISPLAY PANEL

    250 mL label

  • INGREDIENTS AND APPEARANCE
    SODIUM IODIDE 
    sodium iodide injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-819
    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:65207-819-25250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/22/2019
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture