Label: POVIDONE-IODINE SCRUB 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 November 24, 2009

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  • ACTIVE INGREDIENT

    Povidone Iodine USP 7.5% w/v (equivalent to 0.75% 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, purified water, sodium hydroxide, Surfonic N-95
  • QUESTIONS


  • POUCH INFORMATION

    TRIAD

    Cat. No. 10-4402
    NDC 50730-4402-3

    7.5% Povidone Iodine, USP
    POVIDONE IODINE
    SCRUB SWABSTICK (3's)

    Triad Disposables, Inc.
    Brookfield, WI 53045 USA

    Antiseptic / Germicide

    For Hospital and Professional Use Only
    Contents:
    3 Swabsticks
    foil
  • CARTON INFORMATION

    TRIAD

    Cat. No. 10-4402
    NDC 50730-4402-3

    7.5% Povidone Iodine, USP
    POVIDONE IODINE
    SCRUB SWABSTICKS (3's)

    Antiseptic / Germicide
    For Hospital and Professional Use Only

    Triad Disposables, Inc.
    Brookfield, WI 53045 USA

    Contents:
    25 Pouches
    3 Swabsticks per Pouch

    carton


  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE SCRUB SWABSTICKS 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.075 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    nonoxynol-9 (UNII: 48Q180SH9T)  
    polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-4402-325 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 finalpart33301/14/1987
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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