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

  • 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 October 1, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient

    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

    Extremely Flammable Do not use near heat, flame or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120⁰F. Intentional misuse by deliberately concentrating and inhaling 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 ingredients in this preparation

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with 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 reach of children.
    If swallowed, get medical help 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 thin layer 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: Avrio Health L.P. Stamford, CT 06901-3431
    305653-0A

  • PRINCIPAL DISPLAY PANEL

    Betadine Dry 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 not finalpart333A06/15/2020
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRI-PAC, INC.020844956MANUFACTURE(67618-165) , PACK(67618-165)