Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9948e401-6e5f-4d14-ad0b-f62735822c2a
Route
TOPICAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5.5 mg)
Inactive Ingredients
Water Hexylene Glycol Cocamine Oxide Polyethylene Glycol 8000 Glycerin Cocamidopropyl Pg-dimonium Chloride Phosphate Methyl Gluceth-20 Phenoxyethanol Myristic Diisopropanolamide Glyceryl Mono- And Dicaprylocaprate Anhydrous Citric Acid Guar Gum Peg-12 Dimethicone (300 Cst) Alcohol .alpha.-tocopherol Acetate Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-29

Description

Benzalkonium Chloride 0.55%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium Chloride 0.55%

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), hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

Section 53413-1

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

Warnings
For external use only
Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Do Not Use
  • In eyes
Active Ingredient

Benzalkonium Chloride 0.55%

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

ECOLAB

6100960

FACILIPRO

Premium Antibacterial

Foam Hand Soap

1250 mL (42.3 US FL OZ)

Active ingredient: Benzalkonium Chloride 0.55%

761097/5402/0321

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA ·

tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.gofacilipro.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), hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

Section 53413-1 (53413-1)

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

Purpose

Antiseptic handwash

Warnings
For external use only
Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.55%

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 This Product  (When using this 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

6100960

FACILIPRO

Premium Antibacterial

Foam Hand Soap

1250 mL (42.3 US FL OZ)

Active ingredient: Benzalkonium Chloride 0.55%

761097/5402/0321

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA ·

tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.gofacilipro.com


Advanced Ingredient Data


Raw Label Data

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