Triadine
FDA Label NDC 50730-8328

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Triadine (NDC 50730-8328). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not, ask a doctor in case of, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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. 10-8328NDC 50730-8328-6POVIDONE 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!128 Fluid Ounces (3.785L)www.triad-group.netTriad Disposables, Inc. Brookfield, WI 53045MADE IN USA

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