Label: POVIDONE-IODINE GEL SWABSTICK- povidone iodine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • Dukal Povidone-Iodine Gel Swabstick Non-Sterile

  • Active Ingredient

    Povidone-Iodine USP 10%

    Purpose

    Antispetic

  • Use

    Antiseptic Skin Preparation

  • Warnings

    For External Use Only

    Do not use

    • If allergic to Iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • Serious burn

    Stop use and ask doctor if

    • infection occurs
    • redness, irritation or swelling develops

    Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    • apply product to skin as needed
    • see product box for additional directions
  • 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, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water

  • Dukal Povidone-Iodine Gel Swabstick

    itemDUKAL™
    CORPORATION

    NDC 65517-0036-1

    REF 899

    Hold Upright and Tear Here

    POVIDONE-IODINE

    Gel Swabstick

    Ready Gel 1X™

    4" (10.2cm)

    Saturated Swabstick

    Drug Facts

    Active ingredients Purpose
    Povidone Iodine USP 10% Antiseptic

    Use Patient preoperative skin preparation: Helps to

    reduce bacterial that potentially can cause skin infection

    1/Pouch 2

    Made in China D07310901 Rev2

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE GEL SWABSTICK 
    povidone iodine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0036-12.3 g in 1 POUCH; Type 0: Not a Combination Product12/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/02/2019
    Labeler - Dukal LLC (791014871)
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