Triadine Scrub
FDA Label NDC 50730-8304

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Triad Group for the product Triadine Scrub (NDC 50730-8304). 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, 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

Otc - Ask Doctor/Pharmacist


Otc - When Using


Stop Use And Ask A Doctor

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 15° - 30° C (59° - 86° F)

Inactive Ingredients

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

Otc - 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 (Tr 8304l B0110)

    Label (Tr 8304l B0110)


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