Triseptin
FDA Label NDC 70472-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dfb Technology Ltd for the product Triseptin (NDC 70472-101). 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:, stop use and ask a doctor if:, keep out of reach of chipdren., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not use:

→ Stop Use And Ask A Doctor If:

→ Keep Out Of Reach Of Chipdren.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

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.

Patient Preoperative Skin Preparation

For preparation of the skin prior to surgery or an injection.
Helps reduce bacteria that can potentially cause skin infection.

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 A Doctor If:

irritation and redness develop
condition persists for more than 72 hours

Keep Out Of Reach Of Chipdren.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Surgical Hand Scrub

Clean under nails with a nail pick. Nails should be maintained with a 1 mm free edge.
Wet hands and forearms.
Dispense palmful (approx. 7 ml) of TRISEPTIN ^® Scrub into the palm of one hand.
Twist fingertips of the opposite hand, working TRISEPTIN under the nails.
Transfer TRISEPTIN to the opposite hand and repeat with fingertips of the other hand.
Rub TRISEPTIN over the hands and up the forearms to just past the elbow, paying particular attention to the nails, cuticles and interdigital spaces for 90 seconds.
Rinse and repeat.
Rinse completely.

Patient Preoperative Skin Preparation

Apply to cleanse the surgical site and surrounding area 12 hours and 6 hours prior to surgery.
Clean the surgical area.
Place a palmful (approx. 7 ml) of TRISEPTIN to the surgical site and surrounding area and rub for 90 seconds paying particular attention to the surgical area.
Rinse and repeat.
Rinse completely.

Other Information

Store upright at 20-25°C (68-77°F).
Avoid freezing and excessive heat.
Protect from light until use.
Shake well.

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.