Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID ea6d45ee-7713-4a90-81a8-6963c7f5c230
Route
TOPICAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Water Cocamine Oxide Hexylene Glycol Polyethylene Glycol 8000 Glycerin Cocamidopropyl Pg-dimonium Chloride Phosphate Phenoxyethanol Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Myristic Diisopropanolamide Myristamine Oxide Citric Acid Monohydrate Methyl Gluceth-20 Glyceryl Mono- And Dicaprylocaprate Alcohol Peg-12 Dimethicone Potassium Citrate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-12 Until 2024-07-06

Description

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.5%

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 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), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1

Questions? call 1-800-35-CLEAN (352-5326)

Warning
  • For external use only
Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

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
When Using the Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Representative Label and Principal Display Panel

Ecolab®

Advanced Antibacterial 

Foaming  Hand Soap

Active ingredient: Benzalkonium chloride 0.5%

1200 mL (40.6 US FL OZ) 6102754

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

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 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), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1 (53413-1)

Questions? call 1-800-35-CLEAN (352-5326)

Purpose

Antiseptic handwash

Warning
  • For external use only
Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

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
When Using the Product (When using the product)
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Representative Label and Principal Display Panel

Ecolab®

Advanced Antibacterial 

Foaming  Hand Soap

Active ingredient: Benzalkonium chloride 0.5%

1200 mL (40.6 US FL OZ) 6102754

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

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