FDA Label for Lugols Strong Iodine
View Indications, Usage & Precautions
Lugols Strong Iodine Product Label
The following document was submitted to the FDA by the labeler of this product Coopersurgical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Contents
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.
Principal Display Panel
Lugol’s
Strong Iodine Solution USP
Contents
One Dozen (12)
8ml Vials
8mL NDC 59365-6064-0
Lugol’s
(STRONG IODINE SOLUTIONS USP)
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