Label: JIANZE POVIDONE IODINE SCRUB- povidone-iodine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 20, 2012

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  • JIANZE POVIDONE IODINE SCRUB SWABSTICK


  • ACTIVE INGREDIENT

    Povidone Iodine USP, 10% W/V (equivalent to 1% tiratable 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 on the eyes
    • use on individuals who are allergic or sensitive to iodine
    • apply over large area 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

    it the condition persists or gets worse.
  • KEEP OUT OF REACH OF CHILDREN.

    In 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 degrees - 30 degrees C (59 degrees - 86 degrees F)

  • INACTIVE INGREDIENTS:

    Citric Acid, Purified Water, Sodium Hydroxide, Nonoxynol-10, Glycerin

  • JIANZE POVIDONE IODINE SCRUB SWABSTICK 25 COUNT of 3 swabsticks (50666-006-01)


    PovidoneIodineScrubSwabstick3

    PovidoneIodineScrubSwabstick3Outer

  • INGREDIENTS AND APPEARANCE
    JIANZE POVIDONE IODINE SCRUB 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50666-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 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:50666-006-0125 in 1 BOX
    14.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E06/14/2012
    Labeler - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
    Registrant - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Jianze Sanitary Material Co., Ltd.421279569manufacture
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