Label: POVIDONE IODINE TOPICAL SOLUTION PAINT- povidone iodine 10% liquid

  • NDC Code(s): 34645-1041-1
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine, USP 10%

    (1.0% available iodine)

  • Purpose

    Antiseptic

  • Use

    prepping intact skin and mucous membranes prior to sugery

  • Warnings

    for external use only

    avoid use on persons allergic to iodine

  • Stop using this product and ask a doctor if

    • skin shows symptoms of irritation, sensitivity, redness, pain or swelling
  • Keep out of reach of children.

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

  • Directions

    Patient preoperative prep

    • apply solution to operative site following povidone iodine scrub application
    • using a circular motion, start at incision site and move outward
    • remove all soiled underdrapes
    • do no allow solution to pool
  • Other information

    • store at room temperature
    • avoid excessive heat (above 104 degrees F/40 degrees C)
    • protect from freezing
    • latex free
  • Inactive Ingredients

    Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide

  • Package Labeling

    label1

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE TOPICAL SOLUTION PAINT 
    povidone iodine 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-1041
    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 ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-1041-188.5 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/31/2015
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-1041)
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