Label: POVIDONE IODINE SCRUB- povidone-iodine swab

  • NDC Code(s): 34645-4025-3
  • 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

    Povidone Iodine USP, 7.5% W/V (equivalent to 0.75% titratable iodine)

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    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 Use

  • WARNINGS



    Warnings For external use only

  • DO NOT USE

    use in the eyes use on individuals who are allergic or sensitive to iodine apply over larger areas of the body use as a first aid antiseptic longer than 1 week unless by a doctor Do not



  • DO NOT USE

    if irritation and redness develop, consult a doctor in case of deep or puncture wounds animal bites serious burns Discontinue use



  • DO NOT USE

    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 Keep out of reach of children

  • 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

    clean the affected area apply a small amount of this products on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first For use as a first aid antiseptic



  • Other information

    store at room temperature: 15o - 30oC (59o-86oF)

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

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

  • PRINCIPAL DISPLAY PANEL

    Image of Pouch Label

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SCRUB 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4025
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-4025-32.5 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)
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