Lugols Strong Iodine
Lugols Strong Iodine Solution
7d8f4f37-948c-4740-8e23-2f23e47ebd5b
HUMAN PRESCRIPTION DRUG LABEL
May 25, 2016
CooperSurgical, Inc.
DUNS: 801895244
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iodine and Potassium Iodide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
8mL NDC 59365-6064-0****
Lugol’s****
(STRONG IODINE SOLUTIONS USP)
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Iodide preparations are contraindicated in patients with known sensitivity to the drugs.
SPL UNCLASSIFIED SECTION
CAUTION****
Federal law restricts this device to sale by or on the order of a physician.
COMPONENTS
CONTENTS
Iodine 0.05 g/ml, Potassium Iodide 0.100 g/ml.
DESCRIPTION SECTION
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 SECTION
HOW SUPPLIED
LUGOL’S is supplied in 8 ml glass single-use bottles.
DOSAGE & ADMINISTRATION SECTION
ADMINISTRATION
LUGOL’S is applied directly to areas needing antiseptic.
WARNINGS SECTION
WARNINGS
For External Use Only.
STORAGE AND HANDLING SECTION
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 AND WASTE HANDLING
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.