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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 29, 2021

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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 not finalpart333A01/30/2017
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-5501)
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