LUGOLS STRONG IODINE- iodine and potassium iodide solution 
CooperSurgical, Inc.

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 0.100 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

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)

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59365-6064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.05 g  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE0.100 g  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59365-6064-112 in 1 CARTON10/01/1992
1NDC:59365-6064-08 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/01/1992
Labeler - CooperSurgical, Inc. (801895244)

Revised: 5/2016
Document Id: b450bf09-e8ef-4647-9e2d-3f658c09f4d9
Set id: 7d8f4f37-948c-4740-8e23-2f23e47ebd5b
Version: 10
Effective Time: 20160525
 
CooperSurgical, Inc.