Contents
Iodine 0.05 g/ml, Potassium Iodide 0.100 g/ml.
Lugols Strong Iodine
FDA Label NDC 59365-6064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coopersurgical, Inc. for the product Lugols Strong Iodine (NDC 59365-6064). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding contents, description, how supplied, indications and usage, administration, warnings, contraindications, caution, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 Vials (Lugols Strong Iodine Solution 01)
8mL NDC 59365-6064-0
Lugol’s
(STRONG IODINE SOLUTIONS USP)
Principal Display Panel8ml Ndc 59365-6064-0lugol’s (strong Iodine Solutions Usp) (Lugols Strong Iodine Solution 02)
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