Antiseptic Foam Handwash Liquid
FDA Label NDC 21749-461

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gojo Industries, Inc. for the product Antiseptic Foam Handwash (NDC 21749-461). 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/ ingrédient actif, purpose, indications, directions/mode d'emploi, warnings/mises en garde, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient/ Ingrédient Actif

→ Purpose

→ Indications

→ Directions/mode D'emploi

→ Warnings/mises En Garde

→ Inactive Ingredients

→ Package Label.principal Display Panel

Active Ingredient/ Ingrédient Actif

Chlorhexidine Gluconate 2% W/W

Gluconate De Chlorhexidine 2% W/W

Purpose

A general purpose antimicrobial handwash, which kills germs that may cause disease.

Un nettoyant pour les mains antimicrobien á large spectre qui élimine les micro-organismes susceptibles de provoquer des maladies.

Indications

Antiseptic cleanser kills harmful bacteria or germs. Dosage: This product should be used daily, as part of the daily cleansing routine

Nettoyant antiseptique tue les bactéries ou les germes nocifs. Posologie: Utiliser par jour, dan le cadre du régime de nettoyage quotidien.

Directions/Mode D'emploi

Wet hands. Apply an adequate amount of soap and work into a rich lather for 15-30 seconds. Rinse thoroughly with water. Dry hands completely.

Se mouiller les maines. Appliquer une quantité adéquate de savon et frotter les mains pendant 15 á 30 secondes jusqu á obtenir une mousse abondante. Rincer abondamment á l'eau. Sécher soigneusement.

Warnings/Mises En Garde

This product is intended for external use only. Contact with the eyes should be avoided and should this occur, the eye should be flushed with water. If irritation develops or increases, use of the product should be disontinued. If irritattion persists for moe than 5 days, consult a physician. Keep out of reach of children.

Pour usage externe seulement, éviter tout contact avec les yeux, le cas échéant, rincer abondamment avec de l'eau, si une irritation apparaít ou s'accentue, cesser l'empoli. Si l'irritation persiste pendant plus de 5 jours, consulter un médcin. Garder hors de portée des enfants.

Inactive Ingredients

Citric acid, cocamide DEA, Hydroxyethylcellulose, Isopropyl Alcohol, Lauramine Oxide, Water (Aqua)

Acide citrique, diéthanolamide de coprah, hydroxyéthylcellulose, alcool isopropylique, oxyde de la diméthylamine laurique, Eau

Package Label.Principal Display Panel

NDC 21749-461-89

Chlorhexidine Gluconate 2% Solution

Antiseptic Lotion Soap

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

330-255-6000

www.GOJO.com

GOJO Canada, Inc.

1100 Squires Beach Road

Pickering, ON L1W 3N8

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