Triadine Whirlpool
FDA Label NDC 50730-8428

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 Whirlpool (NDC 50730-8428). 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 use, 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,10% (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
  • use as a first aid antiseptic for longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

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 or gets worse
  • if irritation and redness develop and persist for over 72 hours.

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

For preparation of the skin prior to surgery:
  • 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 20° - 25° C (68° - 77° F)

Inactive Ingredients

Citric acid, glycerin, nonoxynol-9, sodium hydroxide, water

Otc - Questions


Label Information

Triad

Cat. No. 10-8428
NDC 50730-8428-6


TRIADINE
POVIDONE-IODINE, USP
WHIRLPOOL CONCENTRATE
10% Solution

Antiseptic / Germicide

For general antiseptic use in Whirlpool or other hydrotherapy tanks.

For External Use Only!


128 Fluid Ounces (3.785 L)


Label (10 8428l B0909)

Label (10 8428l B0909)




* Please review the disclaimer below.