Label: POVIDONE IODINE PREP PAD - povidone-iodine solution

  • NDC Code(s): 50730-3201-1
  • Packager: H and P Industries, Inc. dba Triad Group
  • 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 December 1, 2009

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Antiseptic

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  • 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
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  • 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.

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  • 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
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  • OTHER INFORMATION

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

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


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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-3201
    Route of Administration TOPICAL, EPIDURAL, PERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine .10 g
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50730-3201-1 100 in 1 CARTON
    1 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333 06/21/1985
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    Name Address ID/FEI Business Operations
    H and P Industries, Inc. dba Triad Group 050259597 manufacture
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