Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 388ca447-2267-419f-acec-17b808b27a5a
Route
TOPICAL
Published
Effective Date 2024-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (8.9 mg)
Inactive Ingredients
Water Cocamine Oxide Glycerin Cocamidopropyl Pg-dimonium Chloride Phosphate Hexylene Glycol Methyl Gluceth-20 Peg-7 Glyceryl Cocoate Lactic Acid Edetate Sodium Peg-12 Dimethicone Glycereth-18 Ethylhexanoate Glycereth-18 Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) D&c Red No. 33 Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-26

Description

Benzalkonium chloride 0.89%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.89%

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, glycerin, cocamidopropyl PG-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, polyquaternium-77, lactic acid, tetrasodium EDTA, PEG-12 dimethicone, glycereth-18 ethylhexanoate, glycereth-18, polyquaternium-7, fragrance, red 33, methylchloroisothiazolinone, methylisothiazolinone

Section 53413-1

Questions? call  1 800 35 CLEAN (352 5326)

Warnings

For external use only

Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.89%

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 in the US).
When Using This Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Directions: Concentrated Solution

Concentrated Solution

  • Do not mix with anything except for potable water.
  • Use bottle labeled for this product only for mixing and dispensing product.
  • open dispenser, place bottle into position, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use
Directions: Ready to Use Solution

Ready-To-Use Solution

  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry

Principal Display Panel and Representative Label

ECOLAB®

Concentrated Antibacterial Foam Hand Soap

2L (0.53 US GAL) 6102625

Active Ingredient: Benzalkonium chloride, 0.89%

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 United States

www.ecolab.com · 781929/5400/0324


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, glycerin, cocamidopropyl PG-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, polyquaternium-77, lactic acid, tetrasodium EDTA, PEG-12 dimethicone, glycereth-18 ethylhexanoate, glycereth-18, polyquaternium-7, fragrance, red 33, methylchloroisothiazolinone, methylisothiazolinone

Section 53413-1 (53413-1)

Questions? call  1 800 35 CLEAN (352 5326)

Purpose

Antiseptic handwash

Warnings

For external use only

Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.89%

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 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
Directions: Concentrated Solution

Concentrated Solution

  • Do not mix with anything except for potable water.
  • Use bottle labeled for this product only for mixing and dispensing product.
  • open dispenser, place bottle into position, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use
Directions: Ready to Use Solution (Directions: Ready-To-Use Solution)

Ready-To-Use Solution

  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry

Principal Display Panel and Representative Label

ECOLAB®

Concentrated Antibacterial Foam Hand Soap

2L (0.53 US GAL) 6102625

Active Ingredient: Benzalkonium chloride, 0.89%

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 United States

www.ecolab.com · 781929/5400/0324


Advanced Ingredient Data


Raw Label Data

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