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 August 1, 2022

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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 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 cae of deep or puncture counds, 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 inforamation

    •  store between 15º-30ºC (59º-86ºF)
  • inactive ingredents

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    TOPCO VIJA0622

    QUESTIONS? 1-888-423-0139

    topcare@topco.com www.topcarebrand.com

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

    Quality Guaranteed

    This TopCare product is laboratory tested to guarantee its highest quality.

    Your total satisfaction is guaranteed.

    Scan here for more information or call 1-888-423-0139

  • principal display panel

    TopCare health

    Compare to Betadine Active Ingredient

    Povidone-Iodine Solution, 10%

    FIRST AID ANTISEPTIC

    • Kills germs in minor cuts, scrapes, and burns
    • Used by Hospitals, Doctors & Nurses
    • Water Soluble

    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:36800-011
    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:36800-011-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/29/2004
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(36800-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(36800-011)
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