Label: JIANZE SURGICAL SCRUB BRUSH NAIL CLEANER- povidone-iodine sponge

  • 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 11, 2012

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  • JIANZE SURGICAL SCRUB BRUSH-SPONGE / NAIL CLEANER


  • Active Ingredient

    Povidone Iodine 10%

  • Purpose

    Antiseptic

  • Uses

    • For cleansing hands and arms prior to surgery
  • Warnings

    • For external use only
    • Do not use in the eyes
  • Stop use and ask a doctor if

    • skin shows symptoms of irritation, sensitivity, redness, pain or swelling
  • Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • Wet hands and forearms with water
    • Clean under nails with nail cleaner
    • Scrub for 3 minutes with the impregnated brush
    • Pay close attention to nails, cuticles, and interdigital spaces
    • Rinse thoroughly with running water
    • Repeat
  • Other Information

    • Store at room temperature
    • Avoid excessive heat above 40 degrees C (104 degrees F)
    • Protect from freezing
    • Latex free
  • Inactive Ingredients

    Hydroxyethylcellulose

    Nonylphenol Ethoxylate

    Purified Water

  • Manufactured by: Changzhou Jianze Sanitary Material Co., Ltd. Changzhou City, Jiangsu Province , China


  • JIANZE SURGICAL SCRUB BRUSH-SPONGE / NAIL CLEANER 20 COUNT (50666-003-01)


    SurgicalScrub1

    SurgicalScrub2

  • INGREDIENTS AND APPEARANCE
    JIANZE SURGICAL SCRUB BRUSH NAIL CLEANER 
    povidone-iodine sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50666-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE2 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50666-003-0120 in 1 CARTON
    120 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E06/01/2012
    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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