Label: FIRST AID ANTISEPTIC- 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 April 14, 2022

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  • Active ingredient

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

  • Purpose

    First aid antiseptic

  • Use

    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 if

    condition persists or gets worse   

  • 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 15º-30ºC (59º-86ºF)
  • Inactive ingredients

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

  • Questions

    call: 1-888-287-1915

  • Satisfaction guaranteed

    for questions or comments please call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Purdure products, LP, Owner of the registered trademark Betadine

    Distributed by: Wal-Mart Stores, Inc.

    Bentonville, AR 72716 Wal-Mart Stores, Inc

  • principal display panel

    NDC 49035-050-34

    equate

    *Compare to Betadine Solution Active Ingredient

    First Aid Antiseptic

    10% Povidone-Iodine Topical Solution

    Kills Germs Promptly in Minor Cuts, Scrapes, and Burns

    NET 8 FL OZ (237 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-050
    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:49035-050-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2010
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(49035-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(49035-050)
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