FDA Label for Iodine And Potassium Iodide
View Indications, Usage & Precautions
Iodine And Potassium Iodide Product Label
The following document was submitted to the FDA by the labeler of this product Humco Holding Group, Inc.. 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.
Active Ingredient
Iodine 5 %
Potassium iodide 10%
Purpose
Iodine supplement
Caution To Physician:
Read the following indications, Side Effects, Precautions and Caotraindications as a reminder in evaluating each case for supplemental iodine.
Use
Source of Iodne
INDICTAIONS: This product has several uses where iodine is indicated. This product may be used in the treatment of hyperthyroidism in the immediate preoperative period in preparation for thyroidectomy. It may be used alone, but more frequently is used after the hyperthyroidism is controlled by an antithyroid drug. It is given during the 10 days immediately prior to the operation. Optimal control of Hyperthyroidism is achieved if antithyroid drugs are first given alone. This product is also used in thyrotoxicosis crisis in conjunction with supportive measures to control fever and adequate fluid intake.
Contraindications:
Iodine should not be given to cases of active Tuberculosis, or those known to be sensitive to iodine, and discontinued in cases later developing a sensitivity to the iodine therapy.
Warnings
WARNING: Large doseage may cause iodine poisoning.
VESICATION AND DESQUAMATION MAY OCCUR IF ALLOWED TO POOL IN CONTACT WITH THE SKIN. EXCESS IODINE SHOULD BE REMOVED WITH ALCOHOL TO PREVENT "IODINE BURNS."
Keep Out Of The Reach Of Children.
In case of acciedntal overose, seek professional assistance or contact a Poison Control Center immediately.
Side Effects And Precautions:
Iodine therapy does not completly control the manifestations of hyperthyroidism in that after a variable period of time, the beneficial effects wear off. With continue administration of iodine, the hyperthyroidism may return in its initial intensity or may 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. Average dosage of iodine may cause skin rash. Iodine readily crosses the placental barrier and may affect the fetus. Prolonged therapy may cause iodism. The ingestion of large quantities of iodine may casue abdominal pain, nausea, vomiting and diarhea.
First Aid Instructions For Accidental Exposure:
If in eyes: Immediately flush eyes with plenty of water for 15 minutes.
If on skin: Immediately wash skin with plenty of water for 15 minutes.
If swallowed: CALL A PHYSICIAN. Do not induce vomiting. If conscious, give water, milk, or milk of magnesia.
Directions:
DOSAGE: USUAL DOSE; 4-1/2 minimis 3 times daily. Dilute with water or juie.
USUSAL DOSE RANGE: 1-1/2 to 15 minims daily.
Other Infomation
CAUTION: THIS CONTAINER IS NOT "CHILD PROOF" AND MUST NOT BE SOLD FOR USE IN OR AROUND THE HOME.
Inactive Ingredient
Purified water
Principal Display Panel
NDC 0395-2775-16
STRONG IODINE
SOLUTION
(LUGOL'S SOLUTION)
Rx Only
16 FL OZ
(1 PT) 473 mL
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