TRIADINE SCRUB (POVIDONE-IODINE) SOLUTION [TRIAD GROUP]

TRIADINE SCRUB (POVIDONE-IODINE) SOLUTION [TRIAD GROUP]
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NDC 50730-8304-2
Set ID a546221f-f6da-4c70-95cf-14ec2242d2c1
Category HUMAN OTC DRUG LABEL
Packager Triad Group
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333
  • ACTIVE INGREDIENT

    Povidone Iodine, 7.5% w/v (equivalent to 0.75% titratable iodine)

  • PURPOSE

    Antiseptic

  • USES

    • Surgical hand scrub for health care professionals
    • 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
    • on individuals who are allergic or sensitive to iodine
    • 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 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 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium phosphate, water
  • QUESTIONS


  • LABEL INFORMATION

    Cat. No. 10-8304
    NDC 50730-8304-2

    TRIADINE™

    POVIDONE-IODINE, USP
    SCRUB SOLUTION
    7.5% Topical Solution


    ANTISEPTIC / GERMICIDE

    •  PRE-SURGICAL HAND SCRUB. Significantly reduces the number of micro-organisms on hand and forearms prior to surgery or patient care.
    • 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 EXTERNAL USE ONLY!


    4 Fluid Ounces (118 ml)

    www.triad-group.net


    TRIAD GROUP, INC.
    700 West North Shore Drive
    Hartland, WI 53029
    MADE IN USA

    label

  • INGREDIENTS AND APPEARANCE
    TRIADINE SCRUB 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8304
    Route of AdministrationTOPICAL
    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:50730-8304-2118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/21/1985
    Labeler - Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    Triad Group050259597manufacture

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