Label: BETADINE DRY POWDER- povidone-iodine aerosol, spray

  • NDC Code(s): 67618-165-01
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2023

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  • Drug Facts

    Active ingredient

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

  • Purpose

    First aidantiseptic

    Uses

    First aidto help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Warnings For external use only

    Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal

    Do not use

    • in or near eyes
    • over large areas of the body
    • if you are allergic to povidone-iodine or any other ingredientsin this preparation

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor.

    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 reachof children.
    If swallowed, get medicalhelp or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area
    • SHAKE WELL BEFORE USE
    • Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily
    • May be covered with a sterile bandage
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
  • Inactive ingredients

    Isobutane,isopropyl myristate, pentrane, propane

  • SPL UNCLASSIFIED SECTION

    Dist. by: AvrioHealth L.P. Stamford, CT 06901-3431
    305653-0A

  • PRINCIPAL DISPLAY PANEL

    BetadineDry Powder Spray
    NDC: 67618-165-01

    Betadine Dry Powder Spray
  • INGREDIENTS AND APPEARANCE
    BETADINE DRY POWDER 
    povidone-iodine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPANE (UNII: T75W9911L6)  
    METHOXYFLURANE (UNII: 30905R8O7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-165-0156.7 mL in 1 CAN; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/15/2020
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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