FDA.reportPublic FDA data

Keystone

Manufacturer
Ecolab Inc.
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:16:14

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 foam 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

Warning

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 foam
  • 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, 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 citrate, fragrance, blue 1

OTC - QUESTIONS SECTION

Questions? call 1 866 781 8787

Representative Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KEYSTONE™

Sysco®

Advanced Antibacterial Foaming Hand Soap

Active Ingredient: Benzalkonium chloride 0.5%

Sysco® 4596843 6101146 ECOLAB®

750 mL (25.3 US FL OZ) 764502/5401/0918

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

Representative labelRepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN3
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD3
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-561-41Keystone750 mL in 1 BOTTLE, PLASTICSOLUTION7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-561KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]3Current NDC, Legacy NDC, 1 package rows20240731_6860a80e-9a5f-40e4-bec3-e7386e541f5b.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-56147593-561-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMINE OXIDEQWA2IZI6FIIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
MYRISTIC DIISOPROPANOLAMIDE17DN142CTKIACT
MYRISTAMINE OXIDEJ086PM3RRTIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
METHYL GLUCETH-20J3QD0LD11PIACT
GLYCERYL CAPRYLOCAPRATEU72Q2I8C85IACT
ALCOHOL3K9958V90MIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
POTASSIUM CITRATEEE90ONI6FFIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML · Source PDF

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.6860a80e-9a5f-40e4-bec3-e7386e541f5b2024-07-30WarningsExact identifier
ndc (package): 47593-561-41
ndc (product): 47593-561
ndc11 (package): 47593056141
spl id: 695c97a6-c8c3-4632-9d45-77f135840db3
spl set id: 6860a80e-9a5f-40e4-bec3-e7386e541f5b

Reported adverse events (FAERS/openFDA)#

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