Label: POVIDONE-IODINE PREP SWABSTICKS- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 22, 2010

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  • ACTIVE INGREDIENT

    Povidone Iodine USP 10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USES

    • Health Care Antiseptic for preparation of the skin prior to surgery
    • First Aid Antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
  • WARNINGS

    For external use only.

    Do not

    • use in the eyes
    • apply over large areas of the body
    • use on individuals who are allergic or sensitive to iodine
    • use as a first aid antiseptic for longer than 1 week unless directed by a doctor

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Stop use and ask a doctor

    • if condition persists for more than 72 hours
    • if irritation and redness develop



    Keep out of reach of children

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

  • DIRECTIONS

    For preparation of the skin prior to surgery
    • clean the affected area
    • remove swab by stick
    • apply to the operative site prior to surgery
    As a first aid antiseptic
    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide
  • QUESTIONS


  • POUCH INFORMATION

    TRIAD

    Cat. No. 10-4102
    NDC 50730-4102-3

    10% Povidone Iodine, USP
    POVIDONE IODINE
    SWABSTICKS (3's)

    Antiseptic / Germicide
    10% Povidone Iodine, USP

    For Hospital and Professional Use Only

    Contents:
    3 Swabsticks

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029

    MADE IN USA
    www.triad-group.net
    foil
  • CARTON INFORMATION

    TRIAD

    Cat. No. 10-4102
    NDC 50730-4102-3

    POVIDONE IODINE
    SWABSTICKS (3's)

    Antiseptic / Germicide

    For Hospital and Professional Use
    10% Povidone Iodine, USP

    25 Pouches
    3 Swabsticks per Pouch

    carton

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP SWABSTICKS 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4102
    Route of AdministrationTOPICAL, EPIDURAL, PERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-4102-325 in 1 BOX
    13 in 1 POUCH
    11.7 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/21/1985
    Labeler - Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    Triad Group050259597manufacture
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