PVP-I POUCH FOIL-FOIL (POVIDONE-IODINE) SOLUTION [DUKAL CORPORATION]

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PVP-I POUCH FOIL-FOIL (POVIDONE-IODINE) SOLUTION [DUKAL CORPORATION]
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NDC 65517-0035-1, 65517-0035-2
Set ID 45aefabf-5283-411a-b509-749977635938
Category HUMAN OTC DRUG LABEL
Packager Dukal Corporation
Generic Name
Product Class
Product Number
Application Number PART333E
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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 Case Label

    DUKAL™
    CORPORATION

    REF 885-500

    STERILE

    POVIDONE-IODINE
    SOLUTION 3/4 OUNCE

    For Professional and Hospital Use

    Not made with Natural Rubber Latex

    500/Case

    1/Pack

    2

    Manufactured For: DUKAL CORPORATION • (631) 656-3800

    Ronkonkoma, NY 11779 • www.dukal.com

    Made in China, Hecho en China, Fabriqué en Chine

    (01) 40665973025047

    Principal Display Panel - 3/4 oz Case Label
  • Principal Display Panel - 3/4 oz Pouch Label

    DUKAL™

    CORPORATION

    REF 885

    NDC 65517-0035-1

    STERILE

    POVIDONE-IODINE

    SOLUTION

    3/4 OUNCE

    ANTISEPTIC

    STERILE

    Principal Display Panel - 3/4 oz Pouch Label
  • Principal Display Panel - 1 oz Case Label

    Dukal®
    Corporation

    REF 886-250

    NDC 65517-0035-2

    STERILE

    POVIDONE-IODINE

    SOLUTION 1 OUNCE

    For Professional and Hospital Use

    Not Made with Natural Rubber Latex

    250/Case

    1/Pack

    2

    Manufactured For: DUKAL CORPORATION • (631) 656-3800

    Ronkonkoma, NY 11779 • www.dukal.com

    Made in China

    (01) 40665973026570

    Principal Display Panel - 1 oz Case Label
  • Principal Display Panel - 1 oz Pouch Label

    Dukal®
    Corporation

    REF 886

    NDC 65517-0035-2

    POVIDONE-IODINE

    1 OZ SOLUTION

    ANTISEPTIC

    STERILE

    Principal Display Panel - 1 oz Pouch Label
  • 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 not finalpart333E01/31/2018
    Labeler - Dukal Corporation (791014871)
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