Strong Iodine Solution

Manufacturer
Safecor Health, LLC
Effective date
2025-01-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 21:22:25

Label at a glance#

ProductStrong Iodine Solution
Active ingredientIODINE, POTASSIUM IODIDE
Label structure11 sections

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.

INDICATIONS

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

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

PRECAUTIONS SECTION

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

WARNINGS SECTION

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

ADVERSE REACTIONS SECTION

Ingestion of large quantities of Strong Iodine Solution may cause abdominal pain, nausea, vomiting and diarrhea. Average doses may cause skin rash.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature

SPL UNCLASSIFIED SECTION

Rx only

SAFECOR HEALTH, LLC
WOBURN, MA 01801

230-02
Rev 05/2019

———Principal Display Panel———

PACKAGE LABEL.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

Product Label
Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204913strong iodine (iodine 5 % / potassium iodide 10 % ) Oral SolutionPSN3
204913iodine 50 MG/ML / potassium iodide 100 MG/ML Oral SolutionSCD3
204913Iodine 50 MG/ML / K+ Iodide 100 MG/ML Oral SolutionSY3
204913Iodine 50 MG/ML / Pot Iodide 100 MG/ML Oral SolutionSY3
204913strong iodine (iodine 5 % / potassium iodide 10 % ) Oral SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-230-15Strong Iodine Solution14 mL in 1 BOTTLESOLUTION/ DROPS143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-230STRONG IODINE SOLUTION SOLUTION/ DROPS [SAFECOR HEALTH, LLC]3Current NDC, Legacy NDC, 1 package rows20250110_ec12b0ab-8fee-4b4f-a6e7-349f60a6f3e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-230-15ML - Milliliter48433-230bc04d926-5316-4c4d-9f60-0bceddf9366a12020-09-14

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48433-23048433-230-15

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
IODINE9679TC07X4ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
WATER059QF0KO0RIACT

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
Strong Iodine SolutionSTRONG IODINE SOLUTIONSafecor Health, LLCec12b0ab-8fee-4b4f-a6e7-349f60a6f3e02025-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 48433-230-15
ndc (product): 48433-230
ndc11 (package): 48433023015
spl id: 3d1d89c5-85de-4aa8-9145-5ec6a25983ce
spl set id: ec12b0ab-8fee-4b4f-a6e7-349f60a6f3e0

Reported adverse events (FAERS/openFDA)#

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