Label: POVIDONE IODINE PREP- povidone-iodine swab

  • NDC Code(s): 34645-5506-0, 34645-5506-1
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 11, 2024

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  • Drug Facts

  • Active ingredient

    Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

    Purpose

    Antiseptic

  • Use

    • Health-care antiseptic for preparation of the skin prior to surgery
    • First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.
  • Warnings

    For external use only.

    Do not

    • use in the eyes
    • use on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body
    • use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and irritation and redness develop. Consult a doctor in case of
    • deep or puncture wounds
    • animal bites
    • serious burns.

    Stop use and consult a doctor

    if the condition persists or gets worse.

    Keep out of reach of children.

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

  • Directions

    For preparation of the skin prior to surgery

    • clean the affected area remove swab by stick
    • apply to the operative site prior to surgery.

    For use as a first aid antiseptic


    • clean the affected area
    • apply a small amount of this product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged,let dry first.
  • Other information

    store at room temperature: 15°—30°C(59°-86°F)

    • Avoid excessive heat
  • Inactive ingredients

    citric acid, purified water, sodium hydroxide, Nonoxynol - 10, glycerin

  • 34645-5506-0

    Label

  • 34645-5506-1

    Label(1)

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-5506-0500 in 1 CARTON08/01/2019
    11 in 1 POUCH
    12.5 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:34645-5506-1250 in 1 CARTON08/01/2019
    23 in 1 POUCH
    213.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/01/2019
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-5506) , label(34645-5506)
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