Label: POVIDONE IODINE IMPREGNATED- povidone iodine sponge

  • NDC Code(s): 34645-4010-4
  • 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 10% (1.0% 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

    open pouch at tear notch

    use sponge sticks to prep desired area

  • Other information

    store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free


  • INACTIVE INGREDIENT

    Inactive Ingredients

    hydroxyethylcellulose, nonoxynol - 10, purified water

  • Package Labeling

    image description

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE IMPREGNATED 
    povidone iodine sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-4010-4100 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2010
    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(34645-4010)
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