Label: POVIDONE IODINE PREP- povidone iodine solution

  • NDC Code(s): 68786-132-01
  • Packager: Sion Biotext Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • Active ingredient

    Povidone Iodine  10% w/v

  • Purpose

    Antiseptic

  • Uses


    • Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes, and burns
    • For preparation of the skin prior to surgery
    • Helps reduce bacteria that can potentially cause skin infection
  • Warnings:

    For External Use Only.


    Do not use

    • In the eyes
    • As a first aid antiseptic for more than 1 week
    • Over large areas of the body


    Ask a doctor before use if you have

    • Deep or puncture wounds
    • Animal bites
    • Serious wounds

    Stop use and ask a doctor if

    • Condition worsens or persists for more than 72 hours
    • Irritation and redness develops

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    • Tear at notch
    • Use only once

    As a first aid antiseptic

    • Clean affected area
    • apply 1 to 3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first.

    For preoperative patient skin preparation

    • Clean affected area
    • Apply to operative site prior to surgery using applicator



  • Other information

    • Store at room temperature
    • Avoid excessive heat

  • Inactive Ingredients:

    • Nonoxynol-9, water

  • Principal Display Panel

    PVP Prep Solution

    First Aid Antiseptic

    NET WT. 0.75 oz

    500 Packets per Case

    Made in Israel

    NDC 68786-132-01



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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-132
    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
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-132-01500 in 1 CASE07/16/2015
    122.18 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/16/2015
    Labeler - Sion Biotext Medical Ltd (532775194)
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