Label: POVIDONE IODINE- povidone-iodine spray 5% liquid

  • NDC Code(s): 0395-9129-93
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Active Ingredient

    Povidone-Iodine 5%

    (0.5% available iodine)

  • Warnings

    For external use only.

  • Do not use:

    • In the eyes
    • Over large areas of the body
    • If you are allergic to povidone-iodine or any other ingredients in this preparation
  • Ask a doctor before use if you have:

    • Deep or puncture wounds
    • Serious burns
    • Animal bites
  • Stop and ask a doctor if:

    • The condition persists or gets worse
    • You need to use this product for more that 1 week
  • Keep out of reach of children

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

  • Other Information

    Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

  • Inactive ingredients:

    citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

  • Directions:

    • Clean the affected area
    • Spray a small amount of product on the area 1 to 3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first
  • Uses

    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Purpose

    Antiseptic

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Principal Display Panel

    Betadine Spray 12-30-22Purdue Betadine Spray.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine spray 5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM IODATE (UNII: I139E44NHL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9129-9389 mL in 1 CONTAINER; Type 0: Not a Combination Product01/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/23/2020
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9129) , pack(0395-9129) , label(0395-9129) , analysis(0395-9129)
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