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

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POVIDONE-IODINE SCRUB SWABSTICK (POVIDONE-IODINE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]
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NDC 50730-4401-1
Set ID 80eeecb6-a397-445b-9e10-f4475b034ced
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 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
    • 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


  • LABEL INFORMATION

    TRIAD

    Cat. No. 10-4401
    NDC 50730-4401-1

    7.5% Povidone Iodine, USP
    POVIDONE IODINE
    SCRUB SWABSTICK (1's)

    Triad Disposables, Inc.
    Hartland, WI 53029 USA

    For Hospital and Professional Use Only
    Antiseptic / Germicide

    Contents:
    1 Swabstick
    foil
  • CARTON INFORMATION

    TRIADINE

    Cat. No. 10-4401
    NDC 50730-4401-1

    Povidone Iodine, USP
    POVIDONE IODINE
    SCRUB SWABSTICK (1's)

    Antiseptic / Germicide

    Triad Disposables, Inc.
    Brookfield, WI 53045

    MADE IN USA

    For Hospital and Professional Use
    Store at Room Temperature

    Contents:
    50 Pouches
    1 Swabstick per Pouch


    carton

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE SCRUB SWABSTICK 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4401
    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:50730-4401-150 in 1 BOX
    11 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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