Label: TRIADINE PREP- povidone-iodine solution

  • 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 April 19, 2010

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

View All Sections
  • ACTIVE INGREDIENT

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

  • PURPOSE

    Antiseptic

  • USES

    • Health-care antiseptic for preparation of the skin prior to surgery
    • First id 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

    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

    For preparation of the skin prior to surgery:
    • clean the 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-8, sodium hydroxide, water
  • QUESTIONS


  • LABEL INFORMATION

    Cat. No. 10-8204
    NDC 50730-8204-4

    TRIADINE™

    POVIDONE-IODINE, USP
    PREP SOLUTION
    10% Topical Solution

    ANTISEPTIC / GERMICIDE

    • 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 Hospital and Professional Use.

    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 PREP 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 mg  in 1 mL
    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:50730-8204-3118 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!