Label: JIANZE POVIDONE IODINE SCRUB - povidone-iodine liquid

  • NDC Code(s): 50666-006-01
  • Packager: Changzhou Jianze Sanitary Material Co., Ltd.
  • 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)

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  • PURPOSE

    Antiseptic

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  • 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.
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  • 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

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  • STOP USE AND CONSULT A DOCTOR

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

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

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  • 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.
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  • OTHER INFORMATION

    Store at room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

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  • INACTIVE INGREDIENTS:

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

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  • JIANZE POVIDONE IODINE SCRUB SWABSTICK 25 COUNT of 3 swabsticks (50666-006-01)
  • INGREDIENTS AND APPEARANCE
    JIANZE POVIDONE IODINE SCRUB 
    povidone-iodine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50666-006
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50666-006-01 25 in 1 BOX
    1 4.5 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 06/14/2012
    Labeler - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
    Registrant - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Jianze Sanitary Material Co., Ltd. 421279569 manufacture
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