Label: STRONG IODINE SOLUTION solution/ drops

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

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Drug Label Information

Updated August 18, 2020

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  • FOR ORAL USE ONLY

  • DESCRIPTION

    Iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.

  • INDICATIONS

    Strong Iodine Solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter.  It can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs.  When used with these drugs, Strong Iodine Solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy.  In addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.

  • CONTRAINDICATIONS

    The use of iodides may be contraindicated in patients with tuberculosis because it is believed they may cause a breakdown of healing lesions.  The use of iodides is contraindicated in patients with iododerma, laryngeal edema, and swelling of salivary glands or increased salivation upon previous exposure to iodides.  Strong Iodine Solution is ineffective in the treatment of postoperative thyroid crisis.

  • PRECAUTIONS

    Iodine therapy does not completely control the manifestations of hyperthyroidism and after a variable period of time, the beneficial effects wear off. With continued administration of the drug, the hyperthyroidism may return in its initial intensity or become even more severe than it was at first. Measurements of the protein-bound iodine or of the uptake of radioiodine are rendered useless if iodine is given.

  • WARNINGS

    Prolonged therapy may cause iodism.  USE IN PREGNANCY:  The drug readily crosses the placental barrier and may affect the fetus if used during pregnancy.

  • ADVERSE REACTIONS

    Ingestion of large quantities of Strong Iodine Solution may cause abdominal pain, nausea, vomiting and diarrhea. Average doses may cause skin rash.

  • DOSAGE

    Strong Iodine Solution is for oral use only.  The usual dosage of Strong Iodine Solution is 2 to 6 drops (0.1 to 0.3 ml) three times daily taken in water after meals for two or three weeks prior to operation. In thyroid crisis the dosage is 1 ml three times a day.

  • HOW SUPPLIED

    Bottles of 14 ml, amber glass with lined plastic closures. Accompanying each bottle is a glass dropper which should be used when the solution is ready to be dispensed to minimize any loss of free iodine through the bulb of the dropper.

  • STORAGE

    Store at room temperature

  • SPL UNCLASSIFIED SECTION

    Rx only

    SAFECOR HEALTH, LLC
    WOBURN, MA 01801

    230-02
    Rev 05/2019

  • ———Principal Display Panel———

    Do Not Use in Eyes

    NDC 48433-230-15
    Rx only

    SAFECOR
    HEALTH

    Strong Iodine
    Solution U.S.P.
    (Lugol's Solution)

    NET CONTENTS 14 mL

    Product Label
  • INGREDIENTS AND APPEARANCE
    STRONG IODINE SOLUTION 
    strong iodine solution solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48433-230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE700 mg  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION1400 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-230-1514 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2008
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675manufacture(48433-230)