Label: BETADINE- povidone-iodine liquid

  • NDC Code(s): 0116-0160-03
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2024

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  • ACTIVE INGREDIENT

    Povidone-iodine, 5%

  • PURPOSE

    First aid antiseptic

  • INDICATIONS & USAGE

    first aid to help prevent infection in minor
    ■ cuts ■ scrapes ■ burns

  • WARNINGS

    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 use and ask a doctor if ■ the condition persists or gets worse
    ■ you need to use this product for more than 1 week

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    ■ 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

  • OTHER SAFETY INFORMATION

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Do Not Freeze

  • INACTIVE INGREDIENT

    pareth 25-9, purified water, sodium hydroxide

  • QUESTIONS

    1-833-288-2684

  • PRINCIPAL DISPLAY PANEL

    Betadine 3oz Spray

  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0160-0388.7 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/07/2024
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-0160)
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