HUMCO STRONG IODINE- iodine and potassium iodide liquid 
Humco Holding Group, Inc.

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.

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HUMCO Strong Iodine Solution (Lugol's Solution)

Strong Iodine Solution

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.

FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

Keep out of the reach of children.

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

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."

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

lugols

HUMCO STRONG IODINE 
iodine and potassium iodide liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0395-2775
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE50 mg  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-2775-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2008
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-2775) , analysis(0395-2775) , pack(0395-2775) , label(0395-2775)

Revised: 3/2022
 
Humco Holding Group, Inc.