Label: POVIDONE IODINE- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • ACTIVE INGREDIENT

    Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USE

    First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

  • WARNINGS

    For external use only.

    Do not

    • use in the eyes
    • use on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body

    Discontinue use and ask a doctor

    • if condition persists or gets worse
    • for use longer than 1 week

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Clean the affected area
    • Apply a small amount of this product to the area 1-3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature: 15° - 30° C (59° - 86° F)

  • INACTIVE INGREDIENTS

    citric acid

    dibasic sodium phosphate

    nonoxynol-9

    glycerin

    purified water

    sofium hydroxide

  • Questions


    Questions or comments?

    1-800-662-3435

    www.goodneighborpharmacy.com

  • LABEL INFORMATION

    GNP Povidone.jpg


  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-053-55236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/01/2005
    Labeler - Amerisource Bergen (007914906)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(24385-053) , manufacture(24385-053) , label(24385-053)
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