Label: DUKAL POVIDONE-IODINE SCRUB WINGED SPONGES- povidone-iodine scrub winged sponges sponge

  • NDC Code(s): 65517-0037-1, 65517-0037-2
  • Packager: Dukal LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • Active Ingredient

    Povidone-Iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    Patient preoperative skin preparation. Helps to reduc bacteria that potentially can cause skin infection.

  • Warnings:

    For external use only.

    • Do not apply to persons allergic to iodine. Do not use in the eyes.

    • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

    Stop use and ask doctor if infection occurs, redness, irritation or swelling develops.

    • Keep out of reach of children
    • If swallowed or gets in eyes, get medical help or contact Poison Control Center right away.
  • Directions

    Apply product to skin as needed.

  • Other Information:

    1% titratable iodine, Avoid excessive heat, Store at room temperature, For hospital or professional use only, Not made with natural rubber latex

  • Inactive Ingredients:

    Alkyl Glucoside, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Lauryl Sulfate, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    910Dukal™

    Povidone-Iodine

    Scrub Winged

    Sponges

    Sterile, Large

    Antispetic

    Drug Facts

    Active ingredient Purpose

    Povidone Iodine USP 10% Antiseptic

    Use Patient preoperative skin preparation. Helps to reduce bacteria

    that potentially can cause skin infection.

    Warnings

    For external use only.

    Do no use if allergic to iodine, in the eyes

    Sterile unless package is damagedor opened

    2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0037-1 REF 910

  • PRINCIPAL DISPLAY PANEL

    Dukal REF 910

    Povidone-Iodine

    Scrub Winged Sponges

    Sterile, Large

    Antiseptic

    For Professional and Hospital Use

    8 Boxes Per Case

    10 Pouches Per Pack

    2 Per Pouch

    Not Made with Natural Rubber Latex Do not re-use NDC 65517-0037-1

    910 Case

  • PRINCIPAL DISPLAY PANEL

    912Dukal™

    Povidone-Iodine

    Scrub Winged

    Sponges

    Sterile, Small

    Antispetic

    Drug Facts

    Active ingredient Purpose

    Povidone Iodine USP 10% Antiseptic

    Use Patient preoperative skin preparation. Helps to reduce bacteria

    that potentially can cause skin infection.

    Warnings

    For external use only.

    Do no use if allergic to iodine, in the eyes

    Sterile unless package is damagedor opened

    4 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0037-2 REF 912

  • INGREDIENTS AND APPEARANCE
    DUKAL POVIDONE-IODINE SCRUB WINGED SPONGES 
    povidone-iodine scrub winged sponges sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0037-12 in 1 POUCH09/15/2022
    1109 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:65517-0037-24 in 1 POUCH03/15/2023
    2109 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/15/2022
    Labeler - Dukal LLC (791014871)
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