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 26, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

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

  • Purpose

    First aid antiseptic

  • Use

    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

    • conditrion persists or gets worse
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply aclean the affected area
    • 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

    Visit us at: Rexall.com or call 1-864-REXALL

    PACKAGED FOR DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • principal display panel

    Since 1903

    REXALL

    Topical Antiseptic

    Microbicide

    Povidone Iodine Solution, 10%

    kills germs in minor burns, cust and scrapes

    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:55910-001
    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:55910-001-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/11/2012
    Labeler - Dolgencorp LLC (068331990)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(55910-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(55910-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!