Label: 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 October 14, 2011

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  • INDICATIONS

    For use as an aid in the treatment of actinomycosis (lump jaw) or actinobacillosis (wooden tongue) and necrotic stomatitis in cattle.
  • EACH 100 mL CONTAINS

    Sodium Iodide .............................. 20 g

    Water for Injection ......................... q.s.

  • STORAGE

    Store between 15 degree C and 30 degree C (59 degree F - 85 degree F).

  • SAFE HANDLING WARNING


    Take time.  Observe label directions
  • VETERINARY INDICATIONS

    For animal use only.

    Keep out reach of children

  • CAUTION

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

  • DOSAGE AND ADMINISTRATION

    For intravenous injection only.

    CATTLE: 15 mL/100 lb body weight (30 mg/lb of body weight). Administer slowly, using aseptic procedures. Inject carefully to avoid deposition outside of the vein.  May be repeated at weekly intervals, if necessary.

  • CAUTION

    Animals vary in their susceptibility to iodides. Administer with caution until the animal's tolerance is determined.  Discontinue treatment if adverse reactions occur.  This is a single dose vial.  No preservatives have been added.  Discard any unused portion.

  • WARNING

    Not for use in pregnant animals, lactating dairy cows or animals exhibiting hyperthyroidism.

  • PRINCIPAL DISPLAY PANEL

    image of container labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    SODIUM IODIDE 
    sodium iodide injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-819
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Iodide (UNII: F5WR8N145C) (Iodide ion - UNII:09G4I6V86Q) Sodium Iodide20 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-819-25250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2011
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture