Label: BETADINE- povidone-iodine spray

  • NDC Code(s): 67618-160-03
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 20, 2023

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  • Drug Facts

    Active ingredients

    Povidone-iodine, 5% (0.5% available iodine)

  • Purpose

    First aid Antiseptic

  • Uses

    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • 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

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

  • Directions

    • clean the affected area
    • spray a small amount of the product on the area 1 to 3 times a daily
    • may be covered with sterile bandage
    • if bandaged, let dry first
  • Other information

    store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Dist. by: Avrio Health L.P. Stamford, CT 06901-3431

  • PRINCIPAL DISPLAY PANEL

    Betadine 3 oz Spray
    NDC: 67618-160-03

    304882-0B
  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone-iodine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-160
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM IODATE (UNII: I139E44NHL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-160-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/1992
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114MANUFACTURE(67618-160)
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