Label: BETADINE SOLUTION- povidone-iodine solution

  • 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 March 5, 2021

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  • Drug Facts

    Active ingredient

    Povidone-iodine, 10% (1% 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
    • apply a small amount of product to the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

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

    citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

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

    305541-0D

  • PRINCIPAL DISPLAY PANEL

    Betadine Solution 8 fl oz Bottle
    NDC: 67618-150-08

    Betadine Solution Bottle
  • INGREDIENTS AND APPEARANCE
    BETADINE  SOLUTION
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-150-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/1980
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884MANUFACTURE(67618-150)