Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID dc7bad8c-2e29-4d5d-b87e-8d9eae7c2c1c
Route
TOPICAL
Published
Effective Date 2024-08-02
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 Peg-12 Dimethicone (300 Cst) Potassium Hydroxide Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-30 Until 2024-08-02

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 hydroxide, fragrance, blue 1

Section 53413-1

Questions? call 1.866.444.7450

Warnings
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
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATIN: 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

MONOGRAM CLEANING DISPOSABLES

CLEAN FORCE

ADVANCED ANTIBACTERIAL      768071

FOAM HAND SOAP

HAND CARE

8000461

25 US FL OZ (750 mL)         H24

Active Ingredient:

Benzalkonium chloride 0.5%

771092/5402/0920

For questions or comments,

call 1-866-444-7450

Manufactured for

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

(c) 2020 Ecolab USA Inc. All rights reserved

Made in U.S.A.

Distributed by                  

US Foods Inc.

Rosemont, IL 60018 USA


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 hydroxide, fragrance, blue 1

Section 53413-1 (53413-1)

Questions? call 1.866.444.7450

Purpose

Antiseptic handwash

Warnings
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)
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATIN: 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)

MONOGRAM CLEANING DISPOSABLES

CLEAN FORCE

ADVANCED ANTIBACTERIAL      768071

FOAM HAND SOAP

HAND CARE

8000461

25 US FL OZ (750 mL)         H24

Active Ingredient:

Benzalkonium chloride 0.5%

771092/5402/0920

For questions or comments,

call 1-866-444-7450

Manufactured for

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

(c) 2020 Ecolab USA Inc. All rights reserved

Made in U.S.A.

Distributed by                  

US Foods Inc.

Rosemont, IL 60018 USA


Advanced Ingredient Data


Raw Label Data

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