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
  • 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 December 30, 2022

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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 not finalpart333A01/23/2020
    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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