Label: JIANZE POVIDONE-IODINE - povidone-iodine gel

  • NDC Code(s): 50666-005-01
  • 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 GEL SWABSTICK
  • ACTIVE INGREDIENT

    Povidone-Iodine USP 10%

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  • PURPOSE

    Antiseptic

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  • USE:

    Antiseptic skin preparation

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  • WARNINGS:

    Do not use if allergic to Iodine.

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  • 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
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  • 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.

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  • DIRECTIONS

    Apply locally as needed.

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  • OTHER INFORMATION

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

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

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  • JIANZE POVIDONE-IODINE GEL SWABSTICK 1 COUNT (50666-005-01)
  • INGREDIENTS AND APPEARANCE
    JIANZE POVIDONE-IODINE 
    povidone-iodine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50666-005
    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
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50666-005-01 2.1 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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