Label: STERILE- povidone-iodine solution

  • NDC Code(s): 83645-552-11
  • Packager: Asia Dynamics Inc., d/b/a ADI Medical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 28, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-lodine USP 10%

    Purpose

    Antiseptic

  • Use

    for antiseptic skin preparation

  • Warnings

    For external use only

    Avoid pooling beneath patient

    do not use

    • if allergic to lodine
    • in the eye

    Stop use and ask a doctor if

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

    Keep out of reach of children.

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

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns
  • Directions

    apply locally as needed

  • Other information

    • 1% titratable iodine
    • for hospital or professional use only
  • Inactive ingredients:

    Nonyl Nonoxynol-10, Glycerin, Purifed Water.

  • Storage

    Avoid excessive heat

    Store at room temperature

  • Package Labeling:

    LabelNDC 83645-552-11

    ADI Medical

  • INGREDIENTS AND APPEARANCE
    STERILE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83645-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83645-552-1122.5 g in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)09/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/27/2023
    Labeler - Asia Dynamics Inc., d/b/a ADI Medical (607022126)
    Registrant - Asia Dynamics Inc., d/b/a ADI Medical (607022126)
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