Lugols Strong Iodine Solution

Dosage Form: solution
Lugols Strong Iodine Solution

CONTENTS      

Iodine 0.05 g/ml, Potassium Iodide 0.105 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

LUGOLS STRONG IODINE  iodine potassium iodide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59365-6064 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.05 g  in 1 mL POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 0.105 g  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59365-6064-1 12 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 8 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (59365-6064-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/01/1992

Labeler - CooperSurgical, Inc. (801895244)

Revised: 11/2009CooperSurgical, Inc.

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