Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 468acf2d-97ff-4cac-91b1-067a1ea382f3

Route

TOPICAL

Published

Effective Date 2025-12-30

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 Active Since 2025-12-30

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 50567-7

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

Section 50569-3

Stop use and ask a doctor if skin irritation or redness occurs 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 1-800-529-5458

Warnings

For external use only

Direction

wet hands thoroughly with product and allow to dry without wiping.
do not use if hands are visibly dirty or greasy; wash hands with soap and water instead.

Do Not Use

in eyes

Active Ingredient

Benzalkonium chloride 0.1%

Other Information

for additional information, see Safety Data Sheet (SDS)
EMERGENCY HEALTH INFORMATION: 1 877 231 2615. If located outside the United States and Canada, call collect 952 853 1713 (number is in the US).

Principal Display Panel and Representative Label

ECOLAB

EXP Foaming Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

1200 mL

(40.6 US FL OZ) 1112848

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

KUSA

782982/8000/0224

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 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs 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 1-800-529-5458

Purpose

Antiseptic handwash

Warnings

For external use only

Direction

wet hands thoroughly with product and allow to dry without wiping.
do not use if hands are visibly dirty or greasy; wash hands with soap and water instead.

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)
EMERGENCY HEALTH INFORMATION: 1 877 231 2615. If located outside the United States and Canada, call collect 952 853 1713 (number is in the US).

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

ECOLAB

EXP Foaming Hand Sanitizer

Active Ingredient: Benzalkonium chloride 0.1%

1200 mL

(40.6 US FL OZ) 1112848

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

KUSA

782982/8000/0224

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)

{"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.", "50567-7": "if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop", "50569-3": "Stop use and ask a doctor if skin irritation or redness occurs 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 1-800-529-5458", "Purpose": "Antiseptic handwash", "Warnings": "For external use only", "Direction": "wet hands thoroughly with product and allow to dry without wiping. do not use if hands are visibly dirty or greasy; wash hands with soap and water instead.", "Do not use": "in eyes", "Active ingredient": "Benzalkonium chloride 0.1%", "Other information": "for additional information, see Safety Data Sheet (SDS) EMERGENCY HEALTH INFORMATION: 1 877 231 2615. If located outside the United States and Canada, call collect 952 853 1713 (number is in the US).", "Principal display panel and representative label": "ECOLAB EXP Foaming Hand Sanitizer Active Ingredient: Benzalkonium chloride 0.1% 1200 mL (40.6 US FL OZ) 1112848 Kay Chemical Company · 8300 Capital Drive Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458 ©2024 Kay Chemical Company All rights reserved KUSA 782982/8000/0224"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.243338 · Updated: 2026-03-14T23:12:02.945870