Label: PVP-I PREP PADS FOIL-FOIL- povidone-iodine swab

  • NDC Code(s): 65517-0034-1, 65517-0034-2
  • Packager: Dukal LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Active Ingredient:

    Povidone Iodine USP 10%

  • Purpose:

    Antiseptic

  • Use:

    For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

  • Warnings:

    For external use only.

  • DO NOT USE

    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 a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
    • Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

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

    Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

  • Other Information:

    1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.

  • Inactive Ingredients:

    Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

  • Principal Display Panel - PVP-I Prep Pads Foil Pouch Label

    Dukal
    Povidone-Iodine Prep Pad

    Sterile

    Antiseptic

    For Professional and Hospital Use

    Not made with natura rubber latex

    Sterile unless package is damaged or opened.

    Manufactured For: Dukal, LLC

    1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

    Made in China

    Dukal is a trademark registered in the

    US Patent & Trademark Office by Dukal, LLC

    1 Per Pouch - 2 - NDC 6551-0034-1 - REF 882

    882

  • Principal Display Panel - PVP-I Prep Pads Paper Pouch Label

    Dukal
    Povidone-Iodine Prep Pad

    Sterile

    Antiseptic

    For Professional and Hospital Use

    Not made with natura rubber latex

    Sterile unless package is damaged or opened.

    Manufactured For: Dukal, LLC

    1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

    Made in China

    Dukal is a trademark registered in the

    US Patent & Trademark Office by Dukal, LLC Rev1

    1 Per Pouch - 2 - NDC 6551-0034-2 - REF 889

    889

  • INGREDIENTS AND APPEARANCE
    PVP-I PREP PADS FOIL-FOIL 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0034-18000 in 1 CASE01/31/2018
    10.5 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:65517-0034-24000 in 1 CASE01/31/2018
    20.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/31/2018
    Labeler - Dukal LLC (791014871)
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