Label: POVIDONE IODINE- povidone iodine 10% liquid

  • NDC Code(s): 0395-9123-16, 0395-9123-98
  • Packager: Humco Holding Group, Inc.
  • 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 March 17, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine 10%

    (1% available iodine)

  • Purpose

    First Aid Antiseptic

  • Use

    First aid antiseptic to prevent infection in minor cuts and burns.

  • Warnings

    For External Use Only

  • Ask a doctor before use if you have

    • deep punture wounds
    • animal bites
    • serious burns
  • Stop use and consult a doctor if

    • the condition persists or gets worse
    • irritation and redness develop and persits for more than 72 hours
  • When using this product do not

    • use in eyes
    • use on individuals who are allergic or sensitive to iodine or use for longer thn 1 week unless directed by a doctor
    • apply over large areas of the body
  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

  • Other information

    store at room temperature, 20-25C (68-77F)

  • Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

  • Sunmark Label

    8 fl oz

    SM 8

    16 fl oz

    SM 16

  • Good Neighbor Label

    GNPPov.jpgGNP

  • Leader Label

    LDRPov.jpgLeader

  • Quality Choice Label

    QCPov.jpgQC

  • Select Brand Label

    SB

  • Publix Label

    Publix

  • Premier Value Label

    PV

  • Fred's Label

    Freds

  • DDM Label

    DDM

  • Rite Aid Label

    RAPov.jpgRA

  • CVS Label

    CVS

  • Vida MIaa Label

    VM

  • HEB Label

    HEB

  • Health Mart Label

    HMPov.jpgHM

  • Purdue Betadine Label

    Purdue Betadine 10.jpg

  • Top Care Label

    Top Care PovidoneTCPov.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9123-98237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    2NDC:0395-9123-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9123) , analysis(0395-9123) , pack(0395-9123) , label(0395-9123)