Label: MAOKANG POVIDONE IODINE- povidone-iodine liquid

  • NDC Code(s): 59050-802-00
  • Packager: Changzhou Maokang Medical Products Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 26, 2024

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  • Drug Facts

  • Active ingredient

    Povidone Iodine 10%

    Purpose

    Antiseptic 

  • Use

    • Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.
  • DOSAGE & ADMINISTRATION

    Patient preoparative skin preparation

  • Warnings

    • For external use only.

    Do not use

    • if allergic to iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep wounds
    • puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation or swelling develops

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Other information

    • 1% titratable iodine
    • Avoid excessive heat
    • Store at room temperature
    • For hospital or professional use only
    • Not madewith natural rubber latex
  • Inactive ingredients

    alkyl glucoside, citricacid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

  • Package Labelling:

    Outer Label.jpg

  • INGREDIENTS AND APPEARANCE
    MAOKANG POVIDONE IODINE 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-802
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-802-0029.5 mL in 1 POUCH; Type 0: Not a Combination Product06/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/11/2024
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-802)
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