Label: SODIUM IODIDE injection, solution

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

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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
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