drug facts

drug facts
SPL v1
SPL
SPL Set ID 1c607f52-64c0-4a86-8fa4-e988dec5fe4b
Route
topical
Published
Effective Date 2024-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 active Since 2024-06-17
Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

Medication Information

Warnings

For external use only

Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • 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 our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if 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 1 800 35 CLEAN (352 5326)

Direction
  • 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%

Stop Use and Ask A Doctor If
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

ProSystem

Proclean

Foam Nexa Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

6102737

750 mL

(25 US FL OZ)

Manufactured by

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

© 2024  Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com

Structured Label Content

Warnings

For external use only

Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • 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 our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if 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 1 800 35 CLEAN (352 5326)

Direction
  • 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%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

ProSystem

Proclean

Foam Nexa Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

6102737

750 mL

(25 US FL OZ)

Manufactured by

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

© 2024  Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.370707 · Updated: 2026-03-14T23:03:06.131630