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

  • NDC Code(s): 11344-050-26
  • Packager: Consumer Product Partners, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • Active ingredient

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

  • Purpose

    First aid antiseptic

  • Uses

    first aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • 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

  • Stop use and ask a doctor if

    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 ® First Aid Solution 10% Povidone-iodine Topical Solution.

  • Adverse reaction

    Distributed by:

    Vi-Jon, LLC

    St. Louis, MO 63114

  • Principal display panel

    Swan ®

    POVIDONE-IODINE SOLUTION 10%

    FIRST AID ANTISEPTIC

    • Helps prevent infection in minor cuts, scrapes and burns

    Compare to Betadine ®*

    4 FL OZ (118 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-050
    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
    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:11344-050-26118 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 DrugM00305/07/2009
    Labeler - Consumer Product Partners, LLC (119091520)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11344-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(11344-050)
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