Label: FIRST AID ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 72476-050-34
  • Packager: RETAIL BUSINESS SERVICES, 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 January 19, 2023

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

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

  • SPL UNCLASSIFIED SECTION

    Distributed by Foodhold USA, LLC

    Landover, MD 20785

    1-877-846-9949

    (c) 2018 Ahold Licensing Sarl

    Quality guaranteed or your money back

  • principal display panel

    Care One

    Povidone Iodine Solution 10%

    First Aid Antiseptic

    Kills germs in minor burns, cuts and scrapes

    Our pharmacists recommend

    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:72476-050
    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:72476-050-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/09/2018
    Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(72476-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(72476-050)
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