Label: BIOTRONIX HEALTHCARE- 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 May 6, 2018

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  • ACTIVE INGREDIENT

    Active ingredient

    Povidone Iodine 10%

  • PURPOSE

    Purpose
    Antiseptic

  • WARNINGS

    Warnings
    For external use only. Do not use in the eyes.

  • STOP USE

    Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

  • DOSAGE & ADMINISTRATION

    Direction

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

    Inactive ingredients

    Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

  • INDICATIONS & USAGE

    Uses For cleansing hands and arms prior to surgery

  • OTHER SAFETY INFORMATION

    Other information

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BIOTRONIX HEALTHCARE 
    povidone iodine sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71389-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71389-101-0120 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)05/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/03/2018
    Labeler - Biotronix Healthcare Industries, Inc. (065762392)
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