Label: POVIDONE IODINE PREP SOLUTION STERILE- povidone-iodine solution

  • NDC Code(s): 34645-0013-1
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-iodine USP 10%

    Purpose

    Antiseptic

  • Use

    Antiseptic 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 or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation, swelling or pain persists or increases

    Store at room temperature.  Avoid pooling beneath patientAvoid excessive heat.

    Keep out of reach of children.

    In case of accidental ingestion, seek professinoal assistance or consult a poion control center immediately

  • Directions

    Apply locally as needed

  • Other information

    • 1% titratable iodine
    • for hospital or professional use only
  • Inactive ingredients

    Purified water, Glycerin, Nonyl nonoxynol-10

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP SOLUTION STERILE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-0013
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-0013-130 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2021
    Labeler - Jianerkang Medical Co., Ltd (530968767)
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