Lugols Strong Iodine Solution

Generic Name: iodine and potassium iodide
Dosage Form: topical solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

PRINCIPAL DISPLAY PANEL

8mL       NDC 59365-6064-0
Lugol’s

(STRONG IODINE SOLUTIONS USP)

LUGOLS STRONG IODINE 
iodine and potassium iodide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: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
Packaging
# Item Code Package Description
1 NDC:59365-6064-1 12 VIAL, SINGLE-USE (12 VIAL) in 1 CARTON
1 NDC:59365-6064-0 8 mL in 1 VIAL, SINGLE-USE
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: 08/2013
 
CooperSurgical, Inc.



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