Label: POVIDONE IODINE PREP- povidone-iodine solution

  • NDC Code(s): 34645-5501-0
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active ingredient

    Povidone lodine USP,7.5% W/V (equivalent to 0.75% 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 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

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 g  in 100 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:34645-5501-010 in 1 CARTON02/03/2017
    125 in 1 BOX
    10.045 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/30/2017
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-5501)
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