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 May 12, 2014

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 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.

  • CAUTION:

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    18-819-25

    Iss. 04-12

    RMS 92-1042

    Lot No.

    Exp. Date

  • 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 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

  • WARNINGS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Trademarks are property of Clipper Distributing Company, LLC

    Manufactured by Nova-Tech Inc. Grand Island, NE 68801

    Net Contents: 250 mL

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    SODIUM IODIDE 20% 
    sodium iodide injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-601
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION20 g  in 250 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-601-06250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2012
    Labeler - Clipper (150711039)
    Registrant - Clipper (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture, api manufacture