Lugols Strong Iodine Package Insert

Prescribing information (package insert) - Lugols Strong Iodine

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

DESCRIPTION

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

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

INDICATIONS AND USAGE

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

ADMINISTRATION

LUGOL’S is applied directly to areas needing antiseptic.

WARNINGS

For External Use Only.

CONTRAINDICATIONS

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

CAUTION

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

STORAGE

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

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lugols Strong Iodine

Rx or OTC

Prescription (Rx)?

This drug is available only with a prescription from a licensed healthcare provider.
Rx

Active ingredients

Iodine 0.05 g/mL, Potassium iodide 0.1 g/mL

Dosage form

Solution

Route

Topical

Marketing status

not in the current FDA NDC Directory

Company (applicant)

CooperSurgical, Inc.

FDA approval

UNAPPROVED DRUG OTHERUnapproved drug

Manufacturers

1 labelers list this drug on DailyMed

Packages (NDC)

Package
0.05 g/mL, 0.100 g/mL – 8 ml in 1 vial, single-use / 12 in 1 carton NDC 59365-6064-0

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.