Label: POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 0869-0050-26, 0869-0050-34
  • Packager: Vi Jon, LLC
  • 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 April 28, 2022

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  • Active ingredient

    Povidone-iodine, 10%(equivalent to 1% available iodine)

    Purpose

    Antiseptic

  • Uses

    first aid to help prevent the risk of infection in: minor cuts, scrapes and  burns

  • Warnings

    For external use only

    do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use

    in case of deep or puncture wounds, animal bites, or serious burns

    Ask A doctor before use if you have

    • condition persists or gets worse

    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 this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first.
  • Other information

    store between 15° - 30°C (59°-86°F)

  • Inactive ingredients

     C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

  • disclaimer

    This product is not manufactured or distributed by the Purdue Products L.P., distributor of Betadine Solution 10% Povidone-iodine Topical Solution.

  • Adverse Reactions Section

    Manufactured by: Vi-Jon, LLC

    St. Louis, MO 63114

    Questions or Comments?

    1-888-593-0593

  • principal display panel

    NDC 0869-0050-34

    Povidone-

    Iodine

    Solution, 10%

    First Aid Antiseptic

    Kills Germs in Minor Burns, Cuts, and Scrapes

    Compare to Active Ingredint of Betadine

    8 FL OZ (237 mL)

    image description

  • principal display panel

    mountain

    falls

    *Compare to

    Betadine

    used by

    hospitals,

    doctors,

    & nurses

    kills germs

    in minor

    burns, cuts

    & scrapes

    10%

    povidone-

    iodine

    solution

    first aid antiseptic

    8 FL OZ (237 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10.34 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-13 PARETH-9 (UNII: 9BXD858P37)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0050-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/07/2009
    2NDC:0869-0050-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/07/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/07/2009
    Labeler - Vi Jon, LLC (790752542)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(0869-0050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(0869-0050)