Label: LUGOLS STRONG IODINE- iodine and potassium iodide solution

  • NDC Code(s): 59365-6064-0, 59365-6064-1
  • Packager: CooperSurgical, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated May 25, 2016

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  • CONTENTS

    Iodine 0.05 g/ml, Potassium Iodide 0.100 g/ml.

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  • 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.

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  • HOW SUPPLIED

    LUGOL’S is supplied in 8 ml glass single-use bottles.

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  • INDICATIONS AND USAGE

    LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.

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  • ADMINISTRATION

    LUGOL’S is applied directly to areas needing antiseptic.

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  • WARNINGS

    For External Use Only.

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  • CONTRAINDICATIONS

    Iodide preparations are contraindicated in patients with known sensitivity to the drugs.

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  • CAUTION 

    Federal law restricts this device to sale by or on the order of a physician.

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  • 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).

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  • 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.

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  • 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

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  • 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)

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  • 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)
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