Label: PVP-I POUCH FOIL-FOIL- povidone-iodine solution

  • NDC Code(s): 65517-0035-1, 65517-0035-2
  • Packager: Dukal LLC
  • Category: HUMAN OTC DRUG LABEL

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 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.

  • 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 - 3/4 oz Pouch Label

    Dukal
    Povidone-Iodine

    3/4 Fluid Ounce

    Solution

    Sterile

    Antiseptic

    Drug Facts

    Active Ingredient Purpose

    Povidone Iodine USP 10% Antiseptic

    Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

    Sterile unless package is damaged or opened.

    0.75 fl oz (22.5 ml) - 2 - NDC 6551-0035-1 - REF 885

    885

  • Principal Display Panel - 1 oz Pouch Label

    Dukal
    Povidone-Iodine

    1 Fluid Ounce

    Solution

    Sterile

    Antiseptic

    Drug Facts

    Active Ingredient Purpose

    Povidone Iodine USP 10% Antiseptic

    Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

    Sterile unless package is damaged or opened.

    1 fl oz (29.5 ml) - 2 - NDC 6551-0035-2 - REF 886

    886

  • INGREDIENTS AND APPEARANCE
    PVP-I POUCH FOIL-FOIL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0035
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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:65517-0035-1500 in 1 CASE01/31/2018
    122 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:65517-0035-2250 in 1 CASE11/09/2018
    229.57 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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