Label: POVIDONE-IODINE PREP- povidone-iodine solution

  • NDC Code(s): 39892-0809-1
  • Packager: Owens & Minor Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-iodine USP 10%

    Purpose

    Antiseptic

  • 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 burns

    Stop use and ask a doctor if

    • infection occurs • redness, irritation, swelling or pain persists or increases  

    Avoid pooling beneath patient

    Avoid excessive heat. Store at room temperature.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    Apply locally as needed

  • Other information

    • 1% titratable iodine • for hospital or professional use only

  • Inactive ingredients

    Purified water, Glycerin, Nonyl nonoxynol-10

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0809
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0809-11.5 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/01/2019
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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