drug facts

drug facts

SPL v4

SPL

SPL Set ID bf0f0e43-953f-4a5c-a529-85bb31019b6f

Route

topical

Published

Effective Date 2024-03-28

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 completed Since 2003-11-04 Until 2017-03-13

Purpose

Antiseptic handwash

Description

Benzalkonium chloride, 0.1%

Medication Information

Warnings

For external use only
Flammable, keep away from fire or flame, heat sparks and sources of static discharge

Uses

for handwashing to decrease bacteria on the skin

Purpose

Antiseptic handwash

Directions

wet hands and 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 (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 USA)

Description

Benzalkonium chloride, 0.1%

Questions?

Call 1-800-35-CLEAN (352-5326)

Do Not Use

In eyes

Active Ingredient

Benzalkonium chloride, 0.1%

Inactive Ingredients:

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

When Using This Product

Discontinue use if irritation and redness develop

Stop Use and Ask A Doctor If

Skin irritation or redness occurs for more than 72 hours

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel/representative Label

ECOLAB

6123674

DigiSan™

E Foam Hand Sanitizer

750 mL (25 US FL OZ)

Active Ingredient:

Benzalkonium chloride 0.1%

706304/5405/1020

This product may be patented

www.ecolab.com/patents

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

5105 Tomken Road · Mississauga ON L4W 2X5 Canada

Made in U.S.A.

www.ecolab.com

Structured Label Content

Warnings

For external use only
Flammable, keep away from fire or flame, heat sparks and sources of static discharge

Uses

for handwashing to decrease bacteria on the skin

Purpose

Antiseptic handwash

Directions

wet hands and 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 (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 USA)

Questions?

Call 1-800-35-CLEAN (352-5326)

Do Not Use (Do not use)

In eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride, 0.1%

Inactive Ingredients: (Inactive ingredients:)

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

When Using This Product (When using this product)

Discontinue use if irritation and redness develop

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

Skin irritation or redness occurs for more than 72 hours

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.

Principal Display Panel/representative Label (Principal Display Panel/Representative Label)

ECOLAB

6123674

DigiSan™

E Foam Hand Sanitizer

750 mL (25 US FL OZ)

Active Ingredient:

Benzalkonium chloride 0.1%

706304/5405/1020

This product may be patented

www.ecolab.com/patents

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

5105 Tomken Road · Mississauga ON L4W 2X5 Canada

Made in U.S.A.

www.ecolab.com

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", "Purpose": "Antiseptic handwash", "Warnings": "For external use only Flammable, keep away from fire or flame, heat sparks and sources of static discharge", "Directions": "wet hands and remove soil dispense palmful spread to cover hands, rub in well air dry, do not rinse or towel dry", "Do not use": "In eyes", "Questions?": "Call 1-800-35-CLEAN (352-5326)", "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 USA)", "Inactive ingredients:": "water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, F&DC blue 1", "When using this product": "Discontinue use if irritation and redness develop", "Stop use and ask a doctor if": "Skin irritation or redness occurs for more than 72 hours", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Principal Display Panel/Representative Label": "ECOLAB 6123674 DigiSan™ E Foam Hand Sanitizer 750 mL (25 US FL OZ) Active Ingredient: Benzalkonium chloride 0.1% 706304/5405/1020 This product may be patented www.ecolab.com/patents Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326) 5105 Tomken Road · Mississauga ON L4W 2X5 Canada © 2020 Ecolab USA Inc · All rights reserved Made in U.S.A. www.ecolab.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:54.810971 · Updated: 2026-03-14T23:02:43.906306