Label: FIRST AID ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 55319-700-26
  • Packager: Family Dollar Services
  • 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 August 7, 2023

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  • Active ingredients

    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 aply 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°-86F)
  • inactive ingredients

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

  • Adverse Event

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    500 VOLVO PARKWAY

    CHESAPEAKE, VA 23320

    NOT 100% SATISFIED?

    Return package and unsued product withing 30 day to any Family Dollar Store for a refund (with receipt) or exchange.

  • Disclaimer

    *This product is not manufactured or distributed by Avrio Health L.P., distributor of Betadine® Antiseptic 10% Povidone-Iodine First Aid Antiseptic.

    MADE IN THE US WITH US AND FOREIGN COMPONENTS

  • Principal display panel

    FAMILY WELLNESS

    COMPARE TO BETADINE® ANTISEPTIC*

    FIRST AID ANTISEPTIC

    10% POVIDONE-IODINE

    KILLS GERMS IN MINOR BURNS, CUTS, AND SCRAPES

    • Used by hospitals, Doctors, and Nurses
    • Water Soluble

    4 FL OZ (118 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-700
    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:55319-700-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/13/2017
    Labeler - Family Dollar Services (024472631)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(55319-700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(55319-700)
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