Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 5b0701df-130b-49c4-8df6-101202e655ab

Route

TOPICAL

Published

Effective Date 2025-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (1 mg)

Inactive Ingredients

Water Isopropyl Alcohol Propylene Glycol Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-05-18

Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash

Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

Uses

for handwashing to decrease bacteria on the skin

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

Section 51727-6

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1

Section 53413-1

Questions? call 1 800 781 8787

Warnings

For external use only

Directions

wash hands to remove soil
dispense palmful
spread to cover hands, rub in well
air dry, do not rinse or towel dry

Do Not Use

in eyes

Active Ingredient

Benzalkonium chloride 0.1%

Other Information

for additional information, see Safety Data Sheet (SDS)
for emergency medical information worldwide, call 1 800 328 0026

When Using This Product

if in eyes, rinse promptly and throughly with water
discontinue use if irritation and redness develop

Representative Label and Principal Display Panel

NDC 47593-581-41

ECOLAB

Special Care

Foam Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

CHG Compatible

Net Contents

25 fl oz (750 mL)

This product may be patented:

www.ecolab.com/patents

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 866 781 8787

Made in United States

769816/8500/1116

Structured Label Content

Uses

for handwashing to decrease bacteria on the skin

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

Section 51727-6 (51727-6)

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1

Section 53413-1 (53413-1)

Questions? call 1 800 781 8787

Purpose

Antiseptic handwash

Warnings

For external use only

Directions

wash hands to remove soil
dispense palmful
spread to cover hands, rub in well
air dry, do not rinse or towel dry

Do Not Use (Do not use)

in eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Other Information (Other information)

for additional information, see Safety Data Sheet (SDS)
for emergency medical information worldwide, call 1 800 328 0026

When Using This Product (When using this product)

if in eyes, rinse promptly and throughly with water
discontinue use if irritation and redness develop

Representative Label and Principal Display Panel (Representative label and principal display panel)

NDC 47593-581-41

ECOLAB

Special Care

Foam Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

CHG Compatible

Net Contents

25 fl oz (750 mL)

This product may be patented:

www.ecolab.com/patents

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 866 781 8787

Made in United States

769816/8500/1116

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for handwashing to decrease bacteria on the skin", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.", "51727-6": "Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1", "53413-1": "Questions? call 1 800 781 8787", "Purpose": "Antiseptic handwash", "Warnings": "For external use only", "Directions": "wash hands to remove soil dispense palmful spread to cover hands, rub in well air dry, do not rinse or towel dry", "Do not use": "in eyes", "Active ingredient": "Benzalkonium chloride 0.1%", "Other information": "for additional information, see Safety Data Sheet (SDS) for emergency medical information worldwide, call 1 800 328 0026", "When using this product": "if in eyes, rinse promptly and throughly with water discontinue use if irritation and redness develop", "Representative label and principal display panel": "NDC 47593-581-41 ECOLAB Special Care Foam Hand Sanitizer Active Ingredient: Benzalkonium chloride 0.1% CHG Compatible Net Contents 25 fl oz (750 mL) This product may be patented: www.ecolab.com/patents Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 866 781 8787 © 2016 Ecolab USA Inc. · All rights reserved Made in United States 769816/8500/1116"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:56.563857 · Updated: 2026-03-14T23:11:59.437858