Label: HUMCO STRONG IODINE- iodine and potassium iodide liquid

  • NDC Code(s): 0395-2775-16
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN PRESCRIPTION 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 December 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Strong Iodine Solution

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  • Active Ingredient

    Iodine 5 %

    Potassium iodide 10%

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  • Purpose

    Iodine supplement

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  • CAUTION TO PHYSICIAN:

    Read the following indications, Side Effects, Precautions and Caotraindications as a reminder in evaluating each case for supplemental iodine.

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  • 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.

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  • 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.

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  • WARNINGS

    WARNING: Large doseage may cause iodine poisoning.

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  • SPL UNCLASSIFIED SECTION

    FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

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  • Keep out of the reach of children.

    In case of acciedntal overose, seek professional assistance or contact a Poison Control Center immediately.

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  • Warnings

    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."

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  • 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.

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  • 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.

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  • 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.

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  • Other infomation

    CAUTION: THIS CONTAINER IS NOT "CHILD PROOF" AND MUST NOT BE SOLD FOR USE IN OR AROUND THE HOME.

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  • Inactive ingredient

    Purified water

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  • Label
  • INGREDIENTS AND APPEARANCE
    HUMCO STRONG IODINE 
    iodine and potassium iodide liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0395-2775
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 50 mg  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0395-2775-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc. 825672884 manufacture(0395-2775) , analysis(0395-2775) , pack(0395-2775) , label(0395-2775)
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