Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5427ae5c-83d1-4395-8155-6837cc22a95f
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (8.9 mg)
Inactive Ingredients
Water Lauramine Oxide Cocamidopropyl Propylene Glycol-dimonium Chloride Phosphate Glycerin Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Hexylene Glycol Methyl Gluceth-20 Peg-7 Glyceryl Cocoate Edetate Disodium Lactic Acid Methylchloroisothiazolinone Peg-12 Dimethicone Glycereth-18 Ethylhexanoate D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

Description

Benzalkonium chloride 1.89%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Dosage and Administration

Directions: Concentrated Solution

  • do not mix with anything except for potable water
  • use only provided bottles for diution and dispensing of ready-to-use product
  • insert probe into bag, twist cap tight, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use

Directions: Ready-To-Use Solution

  • wet hands with warm water
  • apply soap to hands and scrub vigorously
  • wash between fingers, around fingernails, and back of hands
  • rinse hands thoroughly with warm water
  • dry hands with clean towel or with mechanical dryer
Description

Benzalkonium chloride 1.89%

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 51727-6

Ingredients (acc. INCI): water (aqua), lauryl dimethylamine oxide, cocoamidopropyl PG-dimonium chloride phosphate, glycerine, polyquaternium-77, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, tetrasodium EDTA, polyquaternium-7, lactic acid, chloro-2-methyl-4-isothiazolin-3-one, PEG-12 dimethicone. glycereth-18 ethylhexanoate, fragrance, D&C Red 33

Section 53413-1

Questions? call 1-800-529-5458

Warnings
For external use only
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 1.89%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask A Doctor If
  •  skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

ECOLAB®  

Concentrated Foaming Antibacterial Hand Soap

FOR INSTITUTIONAL USE ONLY

Distributed by | Distribuido por:

Kay Chemical Company · 8300 Capital Drive

Greensboro NC 27409-9790 USA

Customer Service: (800) 529-5458

©2016 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

763845-00 KUSA 7+3845/8000/0116

Net contents: 2L (0.53 US Gal)


Structured Label Content

Uses
  • for handwashing to decrease bacteria on the skin
Dosage and Administration (34068-7)

Directions: Concentrated Solution

  • do not mix with anything except for potable water
  • use only provided bottles for diution and dispensing of ready-to-use product
  • insert probe into bag, twist cap tight, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use

Directions: Ready-To-Use Solution

  • wet hands with warm water
  • apply soap to hands and scrub vigorously
  • wash between fingers, around fingernails, and back of hands
  • rinse hands thoroughly with warm water
  • dry hands with clean towel or with mechanical dryer
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 51727-6 (51727-6)

Ingredients (acc. INCI): water (aqua), lauryl dimethylamine oxide, cocoamidopropyl PG-dimonium chloride phosphate, glycerine, polyquaternium-77, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, tetrasodium EDTA, polyquaternium-7, lactic acid, chloro-2-methyl-4-isothiazolin-3-one, PEG-12 dimethicone. glycereth-18 ethylhexanoate, fragrance, D&C Red 33

Section 53413-1 (53413-1)

Questions? call 1-800-529-5458

Purpose

Antiseptic handwash

Warnings
For external use only
Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

Benzalkonium chloride 1.89%

Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product (When using this product)
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  •  skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

ECOLAB®  

Concentrated Foaming Antibacterial Hand Soap

FOR INSTITUTIONAL USE ONLY

Distributed by | Distribuido por:

Kay Chemical Company · 8300 Capital Drive

Greensboro NC 27409-9790 USA

Customer Service: (800) 529-5458

©2016 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

763845-00 KUSA 7+3845/8000/0116

Net contents: 2L (0.53 US Gal)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)