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

Drug Label Information

Updated 11/14

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  • CONTENTS      

    Iodine 0.05 g/ml, Potassium Iodide 0.105 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)

    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 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 (IODIDE ION) IODIDE ION 0.105 g  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59365-6064-1 12 in 1 CARTON
    1 NDC:59365-6064-0 8 mL in 1 VIAL, SINGLE-USE; Combination Product Type = C112160
    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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