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

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JIANZE POVIDONE-IODINE (POVIDONE-IODINE) GEL [CHANGZHOU JIANZE SANITARY MATERIAL CO., LTD.]
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NDC 50666-005-01
Set ID d479839e-b626-48f9-b058-df370aabaa3e
Category HUMAN OTC DRUG LABEL
Packager Changzhou Jianze Sanitary Material Co., Ltd.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333E
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  • JIANZE POVIDONE-IODINE GEL SWABSTICK


  • ACTIVE INGREDIENT

    Povidone-Iodine USP 10%

  • PURPOSE

    Antiseptic

  • USE:

    Antiseptic skin preparation

  • WARNINGS:

    Do not use if allergic to Iodine.

  • STOP USE AND ASK A DOCTOR IF:

    • redness, irritation, swelling or pain persists or increases
    • infection occurs
    • injuries are deep or puncture wounds or serious burns
  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

    For External Use Only.

  • DIRECTIONS

    Apply locally as needed.

  • OTHER INFORMATION

    • 1% titratable iodine
    • latex free
  • INACTIVE INGREDIENTS:

    Disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, dimethicone, water.

  • JIANZE POVIDONE-IODINE GEL SWABSTICK 1 COUNT (50666-005-01)

    PovidoneIodineGelSwabstick.

  • INGREDIENTS AND APPEARANCE
    JIANZE POVIDONE-IODINE 
    povidone-iodine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50666-005
    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
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50666-005-012.1 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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