Label: JIANZE POVIDONE-IODINE- povidone-iodine gel

  • 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 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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