HUMCO Strong Iodine Solution (Lugol's Solution)

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2022-03-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 22:05:52

Label at a glance#

ProductHumco Strong Iodine
Active ingredientIODINE, POTASSIUM IODIDE
Label structure16 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Strong Iodine Solution

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Iodine 5 %

Potassium iodide 10%

Purpose

OTC - PURPOSE SECTION

Iodine supplement

CAUTION TO PHYSICIAN:

GENERAL PRECAUTIONS SECTION

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

Use

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

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

WARNINGS SECTION

WARNING: Large doseage may cause iodine poisoning.

SPL UNCLASSIFIED SECTION

FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

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:

PRECAUTIONS SECTION

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:

OTHER SAFETY INFORMATION

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 & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

Purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lugolslugols

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-2775-16ML - Milliliter0395-27753737363e-5d60-4b66-a9b6-fe93bd04116512013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IODINEACTIVE INGREDIENT9679TC07X42
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J2
IODIDE IONACTIVE MOIETY09G4I6V86Q2
IODINEACTIVE MOIETY9679TC07X42
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-27750395-2775-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
IODINE9679TC07X4ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
da6c5009-ea01-25c6-e053-2995a90ab727cf5b0102-4f76-4f9e-907a-bf9425890aea2022-03-17WarningsExact identifier
spl id: da6c5009-ea01-25c6-e053-2995a90ab727
spl set id: cf5b0102-4f76-4f9e-907a-bf9425890aea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.