Label: TRIADINE- 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

    • Surgical hand scrub for health care processionals
    • 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

    As a surgical hand scrub for use by health care professionals
    • clean under nails with a nail pick
    • nails should be maintained with 1 millimeter free edge
    • wet hands and forearms
    • apply milliliter (teaspoon) or palmful to hands and forearms
    • scrub thoroughly paying particular attention to nails, cuticles and interdigital spaces
    • rinse and repeat scrub
    For preparation of the skin prior to surgery
    • clean the affected area
    • 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-9, PEG-300, sodium hydroxide, sodium phosphate, water
  • QUESTIONS


  • LABEL INFORMATION

    Triad

    Cat. No. 10-8308
    NDC 50730-8308-3

    scrub

    POVIDONE IODINE
    SOLUTION, USP

    7.5% Povidone Iodine (0.75% titratable iodine)

    Antiseptic / Germicide

    Antiseptic for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

    First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

    For hospital and professional use only

    Triad Disposables, Inc.
    Brookfield, WI 53045 USA

    8 fl. oz.(236 ml)


    label


  • INGREDIENTS AND APPEARANCE
    TRIADINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8308
    Route of AdministrationTOPICAL, EPIDURAL, PERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.075 mL  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:50730-8308-3236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/21/1985
    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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