Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID f71032b9-9c7e-458f-8859-4548dfd86217

Route

TOPICAL

Published

Effective Date 2025-12-17

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 2025-12-17

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 51727-6

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

Section 53413-1

Questions? Call 1-800-529-5458

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 (SDS)
Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713

When Using This Product

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

Stop Use and Ask A Doctor If

skin irritation and redness occurs for more than 72 hours

Principal Display Panel and Representative Label

KAY

Foaming Hand Sanitizer

KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY

Benzalkonium chloride 0.1%

Net contents: 42 US fl oz (1250 ml)

Distributed by:

Kay Chemical Company • 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

757547-02 • KUSA 757547/8002/0618

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 51727-6 (51727-6)

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

Section 53413-1 (53413-1)

Questions? Call 1-800-529-5458

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 (Do not use)

In eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Other Information

for additional information, see Safety Data Sheet (SDS)
Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713

When Using This Product (When using this product)

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

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

skin irritation and redness occurs for more than 72 hours

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

KAY

Foaming Hand Sanitizer

KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY

Benzalkonium chloride 0.1%

Net contents: 42 US fl oz (1250 ml)

Distributed by:

Kay Chemical Company • 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

757547-02 • KUSA 757547/8002/0618

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.", "51727-6": "Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)", "53413-1": "Questions? Call 1-800-529-5458", "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 (SDS) Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713", "When using this product": "if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop", "Stop use and ask a doctor if": "skin irritation and redness occurs for more than 72 hours", "Principal Display panel and representative label": "KAY Foaming Hand Sanitizer KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY Benzalkonium chloride 0.1% Net contents: 42 US fl oz (1250 ml) Distributed by: Kay Chemical Company • 8300 Capital Drive Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458 ©2018 Kay Chemical Company All rights reserved 757547-02 • KUSA 757547/8002/0618"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:47.600941 · Updated: 2026-03-14T23:11:35.907821