LUGOLS STRONG IODINE- iodine and potassium iodide solution

Lugols Strong Iodine by

Drug Labeling and Warnings

Lugols Strong Iodine by is a Prescription medication manufactured, distributed, or labeled by CooperSurgical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

8mL       NDC: 59365-6064-0
Lugol’s
(STRONG IODINE SOLUTIONS USP)

INGREDIENTS AND APPEARANCE

LUGOLS STRONG IODINE 
iodine and potassium iodide solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	0.05 g  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	0.100 g  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59365-6064-1	12 in 1 CARTON	10/01/1992
1	NDC: 59365-6064-0	8 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

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)