JIANZE POVIDONE IODINE SCRUB (POVIDONE-IODINE) LIQUID [CHANGZHOU JIANZE SANITARY MATERIAL CO., LTD.]

JIANZE POVIDONE IODINE SCRUB (POVIDONE-IODINE) LIQUID [CHANGZHOU JIANZE SANITARY MATERIAL CO., LTD.]
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NDC 50666-006-01
Set ID 4f669107-3869-454f-a82a-61a384422fcb
Category HUMAN OTC DRUG LABEL
Packager Changzhou Jianze Sanitary Material Co., Ltd.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333E
  • 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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