Label: HUMCO POVIDONE IODINE- povidone iodine 10% liquid

  • NDC Code(s): 0395-2325-16, 0395-2325-98
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine 10%

    (Equivalent to 1% titrable iodine)

  • Purpose

    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.

  • Principal Display Panel

    Label 8 fl oz

    Label 8 fl oz

  • Principal Display Panel

    Humco PovidoneLabel 16 fl oz

    Label 16 fl oz

  • New Label 16 oz

    new label 16

  • INGREDIENTS AND APPEARANCE
    HUMCO POVIDONE IODINE 
    povidone iodine 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-2325
    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:0395-2325-98237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    2NDC:0395-2325-16473 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 DrugM00301/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-2325) , analysis(0395-2325) , pack(0395-2325) , label(0395-2325)
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