Label: POVIDONE IODINE PREP PAD- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL

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 December 1, 2009

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Antiseptic

  • USES

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

    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily and discard
    • may be covered with a sterile bandage when dry
  • 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


  • PACKAGE INFORMATION

    Triad

    Cat. No. 10-3201
    NDC 50730-3201-1

    Povidone Iodine
    Prep Pads

    Antiseptic / Germicide
    • Helps prevent the risk of infection in minor cuts, scrapes and burns
    • Health-care antiseptic for preparation of the skin prior to surgery
    • For Professional and Hospital Use Only
    • 10% Povidone Iodine, USP
    Latex Free

    100 Pads

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029
    www.triad-group.net
    1-800-288-1288

    MADE IN USA

    carton


  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-3201
    Route of AdministrationTOPICAL, EPIDURAL, PERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 g
    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:50730-3201-1100 in 1 CARTON
    11 in 1 POUCH
    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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