drug facts

drug facts

SPL v1

SPL

SPL Set ID 09899c40-6e4a-48a9-8d09-d374f6ab855f

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

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

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 (SDS)
for emergency medical information in USA call 1-800-391-1504

Description

Benzalkonium chloride 0.1%

Questions?

Call 1-800-532-7732

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, FD&C Red 40, FD&C Blue 1

Do Not Use

In eyes

Active Ingredient

Benzalkonium chloride 0.1%

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 or redness occurs for more than 72 hours

Principal Display Panel and Representative Container

SSDC

MYSTIC

Foaming Hand Sanitizer

Benzalkonium chloride 0.1%

Net Contents: 1250 mL/42.3 US fl oz

Distributed by: SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

Structured Label Content

Warnings

For external use only

Uses

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 (SDS)
for emergency medical information in USA call 1-800-391-1504

Questions?

Call 1-800-532-7732

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, FD&C Red 40, FD&C Blue 1

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 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 or redness occurs for more than 72 hours

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

SSDC

MYSTIC

Foaming Hand Sanitizer

Benzalkonium chloride 0.1%

Net Contents: 1250 mL/42.3 US fl oz

Distributed by: SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

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, FD&C Red 40, FD&C Blue 1", "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", "Questions?": "Call 1-800-532-7732", "Active ingredient": "Benzalkonium chloride 0.1%", "Other information": "for additional information, see Safety Data Sheet (SDS) for emergency medical information in USA call 1-800-391-1504", "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 or redness occurs for more than 72 hours", "Principal display panel and representative container": "SSDC MYSTIC Foaming Hand Sanitizer Benzalkonium chloride 0.1% Net Contents: 1250 mL/42.3 US fl oz Distributed by: SSDC Division, Kay Chemical Company 4050 Corporate Drive, #100 Grapevine, Texas 76051, USA 800.532.7732"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:45.080760 · Updated: 2026-03-14T23:11:30.674942