FDA.reportPublic FDA data

Keystone

Manufacturer
Ecolab Inc.
Effective date
2024-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:33

Label at a glance#

ProductKeystone
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

wet hands and apply product scrub hands and forearms rinse thoroughly and dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride, 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes

When using the product

OTC - WHEN USING SECTION

  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands and apply product
  • scrub hands and forearms
  • rinse thoroughly and dry

Other information

REFERENCES SECTION

  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026

INACTIVE INGREDIENT SECTION

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquatemium-7, fragrance, potassium hydroxide, blue 1

OTC - QUESTIONS SECTION

Questions? call 1-866-781-8787

Principal display panel and representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KEYSTONE Sysco

ADVANCED ANTIBACTERIAL LIQUID HAND SOAP

Active Ingredient: 0.5% Benzalkonium Chloride

Net Contents

750 mL (25 US fl oz) 6000234

Sysco 5287436      6101969 ECOLAB®

This product may be patented: www.ecolab.com/patents

For SDS information visit: www.cleanwithkeystone.com

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

© 2018 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com · 773734/5400/0818

representative labelrepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN2
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD2
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-594-11Keystone3780 mL in 1 BOTTLE, PLASTICSOLUTION37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-594KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]2Current NDC, Legacy NDC, 1 package rows20240806_14ba88a3-af32-4191-afed-cdcc7eb8ad6a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-59447593-594-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMINE OXIDEQWA2IZI6FIIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
MYRISTIC DIISOPROPANOLAMIDE17DN142CTKIACT
MYRISTAMINE OXIDEJ086PM3RRTIACT
METHYL GLUCETH-20J3QD0LD11PIACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
ALCOHOL3K9958V90MIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.14ba88a3-af32-4191-afed-cdcc7eb8ad6a2024-08-05WarningsExact identifier
ndc (package): 47593-594-11
ndc (product): 47593-594
ndc11 (package): 47593059411
spl id: 912823fb-4be3-43a4-a634-0d06c6ec86b8
spl set id: 14ba88a3-af32-4191-afed-cdcc7eb8ad6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.