Label: ADI MEDICAL PVP-I POUCH, FOIL- povidone-iodine solution

  • NDC Code(s): 83645-550-11
  • Packager: Asia Dynamics Inc., d/b/a ADI Medical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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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
    ADI MEDICAL PVP-I POUCH, FOIL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83645-550
    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:83645-550-1150 in 1 CASE09/27/2023
    122.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/27/2023
    Labeler - Asia Dynamics Inc., d/b/a ADI Medical (607022126)
    Registrant - Asia Dynamics Inc., d/b/a ADI Medical (607022126)
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