Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 4c2bcf98-a2c8-48ee-a3e0-e49cb667b27e

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 2016-06-14 Until 2023-07-12

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 50569-3

Stop use and ask a doctor if skin irritation and redness develop

Section 51727-6

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

Section 53413-1

Questions? call 1-866-444-7450

Warnings

For external use only

Directions

Wash hands to remove soil
dispense 20 mL into hand (palmful)
spread to cover hands, rub in well for at least 30 seconds
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 in USA and Canada, call 1-800-328-0026
for emergency medical information worldwide, call 1-651-222-5352 (in the USA)

When Using This Product

Discontinue use if irritation and redness develop

Principal Display Panel and Representative Label

Foodservice Foaming

Hand Sanitizer

Hand Care

Active ingredient: Benzalkonium Chloride 0.1%

Product No.

8000360

25 US FL OZ

(750 mL)

766561/5401/1021

For questions or comments,

call 1-866-444-7450.

Distributed by

Ecolab

1 Ecolab Place

St Paul MN 55102 USA

Made in U.S.A.

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 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation and redness develop

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 1-866-444-7450

Purpose

Antiseptic handwash

Warnings

For external use only

Directions

Wash hands to remove soil
dispense 20 mL into hand (palmful)
spread to cover hands, rub in well for at least 30 seconds
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 in USA and Canada, call 1-800-328-0026
for emergency medical information worldwide, call 1-651-222-5352 (in the USA)

When Using This Product (When using this product)

Discontinue use if irritation and redness develop

Principal Display Panel and Representative Label

Foodservice Foaming

Hand Sanitizer

Hand Care

Active ingredient: Benzalkonium Chloride 0.1%

Product No.

8000360

25 US FL OZ

(750 mL)

766561/5401/1021

For questions or comments,

call 1-866-444-7450.

Distributed by

Ecolab

1 Ecolab Place

St Paul MN 55102 USA

Made in U.S.A.

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.", "50569-3": "Stop use and ask a doctor if skin irritation and redness develop", "51727-6": "Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1", "53413-1": "Questions? call 1-866-444-7450", "Purpose": "Antiseptic handwash", "Warnings": "For external use only", "Directions": "Wash hands to remove soil dispense 20 mL into hand (palmful) spread to cover hands, rub in well for at least 30 seconds 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 in USA and Canada, call 1-800-328-0026 for emergency medical information worldwide, call 1-651-222-5352 (in the USA)", "When using this product": "Discontinue use if irritation and redness develop", "Principal Display Panel and Representative Label": "Foodservice Foaming Hand Sanitizer Hand Care Active ingredient: Benzalkonium Chloride 0.1% Product No. 8000360 25 US FL OZ (750 mL) 766561/5401/1021 For questions or comments, call 1-866-444-7450. Distributed by Ecolab 1 Ecolab Place St Paul MN 55102 USA © 2021 Ecolab USA Inc All rights reserved Made in U.S.A."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:56.549666 · Updated: 2026-03-14T23:11:59.437858