Biocentris E2 Handwash
FDA Label NDC 81232-402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biocentris Pharmaceuticals, Llc for the product Biocentris E2 Handwash (NDC 81232-402). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Benzalkonium chloride 0.13% w/w

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

Warnings

Warnings

  • For external use only.
  • Keep out of eyes, ears, or mouth. Incase of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
  • Rinse with water and towel dry.

Inactive Ingredient

Inactive ingredients Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.

Package Label.Principal Display Panel

E2 FOAM HANDWASH FOR FOOD INDUSTRY PROFESSIONALS

One Step Hand Wash & Sanitizer

ADVANCED QUAT FORMULA

50mL

888-497-4375

[email protected]

www.biocentris.com

biocentris

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