drug facts

drug facts

SPL v7

SPL

SPL Set ID 8331383f-4608-4abd-86e7-184a79409ba8

Route

topical

Published

Effective Date 2025-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

benzalkonium (0.1 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 completed Since 2010-12-08 Until 2026-07-06

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

Medication Information

Warnings

For external use only

Indications and Usage

for handwashing to decrease bacteria on the skin

Purpose

Antiseptic handwash

Directions

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

Other Information

For additional information, see Safety Data Sheet (MSDS)
EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Description

Benzalkonium chloride 0.1%

Section 50565-1

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

Section 51727-6

Inactive ingredients water, propylene glycol, isopropyl alcohol, FD&C red 40, FD&C blue1

Section 53413-1

Questions? call 1-800-35-CLEAN (352-5326)

Do Not Use

in eyes

Active Ingredient

Benzalkonium chloride 0.1%

When Using This Product

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

Stop Use and Ask Doctor If

skin irritation or redness persists for more than 72 hours

Principal Display Panel and Representative Container

Ecolab

6100730

Foodservice Foam Hand Santiizer

1250 mL (42.3 US FL OZ)

Active ingredient:

Benzalkonium chloride 0.1%

755555/5402/0920

Ecolab - 1 Ecolab Place - St. Paul MN 55102 USA

tel: 1 800 35 CLEAN (352 5326)

Made in U.S.A.

www.ecolab.com

Structured Label Content

Warnings

For external use only

Indications and Usage (34067-9)

for handwashing to decrease bacteria on the skin

Purpose

Antiseptic handwash

Directions

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

Other Information (Other information)

For additional information, see Safety Data Sheet (MSDS)
EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

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 51727-6 (51727-6)

Inactive ingredients water, propylene glycol, isopropyl alcohol, FD&C red 40, FD&C blue1

Section 53413-1 (53413-1)

Questions? call 1-800-35-CLEAN (352-5326)

Do Not Use (Do not use)

in eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

When Using This Product (When using this product)

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

Stop Use and Ask Doctor If (Stop use and ask doctor if )

skin irritation or redness persists for more than 72 hours

Principal Display Panel and Representative Container (Principal display panel and representative container)

Ecolab

6100730

Foodservice Foam Hand Santiizer

1250 mL (42.3 US FL OZ)

Active ingredient:

Benzalkonium chloride 0.1%

755555/5402/0920

Ecolab - 1 Ecolab Place - St. Paul MN 55102 USA

tel: 1 800 35 CLEAN (352 5326)

Made in U.S.A.

www.ecolab.com

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "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)

{"34067-9": "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.", "51727-6": "Inactive ingredients water, propylene glycol, isopropyl alcohol, FD&C red 40, FD&C blue1", "53413-1": "Questions? call 1-800-35-CLEAN (352-5326)", "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 (MSDS) EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).", "When using this product": "if in eyes, rinse promptly and throughly with water discontinue use if irritation and redness develop", "Stop use and ask doctor if ": "skin irritation or redness persists for more than 72 hours", "Principal display panel and representative container": "Ecolab 6100730 Foodservice Foam Hand Santiizer 1250 mL (42.3 US FL OZ) Active ingredient: Benzalkonium chloride 0.1% 755555/5402/0920 Ecolab - 1 Ecolab Place - St. Paul MN 55102 USA tel: 1 800 35 CLEAN (352 5326) (c) 2020 Ecolab USA Inc - All rights reserved Made in U.S.A. www.ecolab.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.584936 · Updated: 2026-03-14T23:08:46.104923