Triseptin
FDA Label NDC 0064-1050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthpoint, Ltd for the product Triseptin (NDC 0064-1050). 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, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

Surgical Hand Scrub:

  • Significantly reduces the number of microorganisms on the hands, forearms and body prior to surgery or patient care.

Warnings

  • Flammable, keep away from fire or flame.
  • For external use only.
  • Do not use
  • if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
  • on or near the eyes, mucous membranes, genital skin, or mouth. If product gets into the eyes, flush immediately with water.
  • Avoid contact with broken skin.
  • Stop use and ask doctor if irritation and redness develop. If condition persists for more than 72 hours consult a physician.
    • Keep out of reach of children.
      • If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Benzethonium chloride, citric acid, cocamine oxide, fragrance, glyceryl laurate, hydroxypropylcellulose, phenylethyl alcohol, phosphoric acid, polyoxyl 40 stearate, propyl gallate, propylene glycol, purified water, zinc pyrithione.

Questions?

Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.triseptin.com.

Marketed by:
CareFusion
Leawood, KS 66211

Manufactured for:
Healthpoint, Ltd.
Fort Worth, TX 76107
by DPT Laboratories, Ltd.
San Antonio, Texas 78215

REORDER NO. 0064-1050-04
PATENT NO. 6,110,908

4 fl oz (118 ml)
129478-0411

PRINCIPAL DISPLAY PANEL

NDC 0064-1050-04

Triseptin®
Ethyl alcohol 70% v/v
Hand & Body Antiseptic

Surgical Hand Scrub

  • Used by surgeons in hospital operating rooms

    • Patient Preoperative Skin Preparation

    • Helps reduce bacteria that can potentially cause skin infection
    • Alcohol and other skin-conditioning ingredients
    • Fast antibacterial action

      • 4 fl oz
      (118 ml)
      129477-0411

      CareFusion

* Please review the disclaimer below.