POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]

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POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]
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NDC 50730-3201-1
Set ID defb9431-790c-47fd-a48a-fd80585e7633
Category HUMAN OTC DRUG LABEL
Packager H and P Industries, Inc. dba Triad Group
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333
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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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