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

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Drug Label Information

Updated May 25, 2016

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  • 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

    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)

  • INGREDIENTS AND APPEARANCE
    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)