FDA Label for Strong Iodine Solution
View Indications, Usage & Precautions
Strong Iodine Solution Product Label
The following document was submitted to the FDA by the labeler of this product Safecor Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
———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
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