FDA Label for Triadine

View Indications, Usage & Precautions

Triadine Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Povidone Iodine USP 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
  • 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

Otc - Ask Doctor/Pharmacist





Otc - When Using





Stop Use And Ask A Doctor



  • if condition persists for more than 72 hours
  • if irritation and redness develop

Otc - Pregnancy Or Breast Feeding





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

Other





Other Information



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

Inactive Ingredients



Citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium phosphate, water

Otc - Questions





Label Information



TriadineCat. No. 10-8332NDC 50730-8332-5POVIDONE IODINE, USPSCRUB SOLUTION7.5% Topical SolutionAntiseptic / GermicidePRE-SURGICAL HAND SCRUB. Significantly reduces the number of micro-organisms on hands and forearms prior to surgery or patient careANTISEPTIC for preparation of the skin prior to surgeryFIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes, and burnsFor External Use Only!32 Fluid Ounces (946 ml)www.triad-group.netTriad Disposables, Inc. Brookfield, WI 53045MADE IN USA

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