Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 59580c40-ca37-4ac9-a2c3-ea86197cf68c
Route
TOPICAL
Published
Effective Date 2025-04-21
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 Anhydrous Citric Acid Methyl Gluceth-20 Glyceryl Mono- And Dicaprylocaprate Alcohol Peg-12 Dimethicone (300 Cst) Potassium Citrate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-23

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 ingredientswater (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 1 866 781 8787

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
Principal Display Panel and Representative Label

ECOLAB   6102762

FACILIPRO

Advanced Antibacterial Foaming Hand Soap

1200 mL (40.6 US FL OZ)

Active Ingredient Benzalkonium chloride 0.5%

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

© 2025 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

783749/5400/0425


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 ingredientswater (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 1 866 781 8787

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

ECOLAB   6102762

FACILIPRO

Advanced Antibacterial Foaming Hand Soap

1200 mL (40.6 US FL OZ)

Active Ingredient Benzalkonium chloride 0.5%

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

© 2025 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

783749/5400/0425


Advanced Ingredient Data


Raw Label Data

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