FDA.reportPublic FDA data

Lugols Strong Iodine Solution

Manufacturer
CooperSurgical, Inc.
Effective date
2016-05-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 20:36:05

Label at a glance#

ProductLugols Strong Iodine
Active ingredientIODINE, POTASSIUM IODIDE
Label structure12 sections

Indications and uses

LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.

Storage and handling

Keep tightly closed. Protect from light.   DO NOT use if seal has been broken. Store at controlled room temperature 15°-30°C (59°-86°F).

Label contents#

Full prescribing information#

CONTENTS

COMPONENTS

Iodine 0.05 g/ml, Potassium Iodide 0.100 g/ml.

DESCRIPTION

DESCRIPTION SECTION

LUGOL’S is an aqueous solution containing Iodine 5%, and potassium iodide 10%, w/v (LUGOL’s Solution). LUGOL’s is a transparent liquid with a deep brown color and the odor of iodine.

HOW SUPPLIED

HOW SUPPLIED SECTION

LUGOL’S is supplied in 8 ml glass single-use bottles.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.

ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

LUGOL’S is applied directly to areas needing antiseptic.

WARNINGS

WARNINGS SECTION

For External Use Only.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Iodide preparations are contraindicated in patients with known sensitivity to the drugs.

CAUTION 

SPL UNCLASSIFIED SECTION

Federal law restricts this device to sale by or on the order of a physician.

STORAGE 

STORAGE AND HANDLING SECTION

Keep tightly closed. Protect from light.  DO NOT use if seal has been broken. Store at controlled room temperature 15°-30°C (59°-86°F).

DISPOSAL

DISPOSAL AND WASTE HANDLING

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for disposal following local hazardous waste practices. Waste containing LUGOL’S should not be subjected to any thermal process whether intended for destruction or recycling purposes.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lugol’s
Strong Iodine Solution USP
Contents
One Dozen (12)
8ml Vials

Lugol’s Strong Iodine Solution USP Contents One Dozen (12) 8ml VialsLugol’s Strong Iodine Solution USP Contents One Dozen (12) 8ml Vials

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8mL       NDC 59365-6064-0
Lugol’s
(STRONG IODINE SOLUTIONS USP)

PRINCIPAL DISPLAY PANEL 8mL NDC 59365-6064-0 Lugol’s (STRONG IODINE SOLUTIONS USP)PRINCIPAL DISPLAY PANEL 8mL NDC 59365-6064-0 Lugol’s (STRONG IODINE SOLUTIONS USP)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205228iodine 5 % / potassium iodide 10 % Topical SolutionPSN10
205228iodine 50 MG/ML / potassium iodide 100 MG/ML Topical SolutionSCD10
205228iodine 5 % / potassium iodide 10 % Topical SolutionSY10
205228Iodine 50 MG/ML / K+ Iodide 100 MG/ML Topical SolutionSY10
205228Iodine 50 MG/ML / Pot Iodide 100 MG/ML Topical SolutionSY10
205228Lugol's strong iodine 5 % / 10 % Topical SolutionSY10

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59365-6064-12021-01-29C16284748780-1ba0f9c33-1788-a910-e053-dadaa90a0b85Lugols Strong Iodine Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-6064-0Lugols Strong Iodine8 mL in 1 VIAL, SINGLE-USESOLUTION810
59365-6064-1Lugols Strong Iodine12 in 1 CARTONSOLUTION1210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59365-6064LUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]10Legacy NDC, 2 package rows20210318_7d8f4f37-948c-4740-8e23-2f23e47ebd5b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59365-6064-0ML - Milliliter59365-60647dbe9896-21f0-4afc-8ee6-a102250d829b12013-10-17
59365-6064-1ML - Milliliter59365-6064ab8e656b-296e-4c35-8f6c-4b2af90e5c5212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IODINEACTIVE INGREDIENT9679TC07X48
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J8
IODIDE IONACTIVE MOIETY09G4I6V86Q8
IODINEACTIVE MOIETY9679TC07X48

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
59365-606459365-6064-0, 59365-6064-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODINE9679TC07X4ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB

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
b450bf09-e8ef-4647-9e2d-3f658c09f4d97d8f4f37-948c-4740-8e23-2f23e47ebd5b2016-05-25WarningsExact identifier
spl id: b450bf09-e8ef-4647-9e2d-3f658c09f4d9
spl set id: 7d8f4f37-948c-4740-8e23-2f23e47ebd5b

Reported adverse events (FAERS/openFDA)#

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