Label: POVIDONE IODINE solution

  • NDC Code(s): 34645-4009-6
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Povidone Iodine, USP 7.5% (0.75% available Iodine)

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For preparation of skin and mucous membranes prior to surgery

  • WARNINGS

    Warnings

    For external use only

    Avoid use on persons allergic to iodine

  • STOP USE

    Stop use and ask a doctor if

    Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    Patient preoperative prep

    use full strength

    apply solution saturated sponge to operative site

    scrub in circular motion for 5 minutes starting at incision site and move outward

    blot with sterile towel

    follow with application of topical solution


  • Other information

    store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free


  • INACTIVE INGREDIENT

    Inactive Ingredients

    alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

  • Package label

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-4009-6109 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2010
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-4009)
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