Keystone

Manufacturer
Ecolab Inc.
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:10:03

Label at a glance#

ProductKeystone
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

wash hands to remove soil dispense 20 mL into hand (palmful) spread to cover hands, rub in well for at least 30 seconds air dry, do not rinse or towel dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1%

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 this product

OTC - WHEN USING SECTION

  • discontinue use if irritation and redness develop

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness develop

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

  • wash hands to remove soil
  • dispense 20 mL into hand (palmful)
  • spread to cover hands, rub in well for at least 30 seconds
  • air dry, do not rinse or towel 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
  • for emergency medical information worldwide, call 1-651-222-5352 (in the USA)

INACTIVE INGREDIENT SECTION

Inactive ingredients  water (aqua), isopropyl alcohol, propylene glycol, red 40, blue 1

Questions?

OTC - QUESTIONS SECTION

call 1-800-35-CLEAN (352-5326)

Primary Display Panel / Representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KEYSTONE   SYSCO

FOAM HAND SANITIZER

Active Ingredient: Benzalkonium chloride 0.1%

Sysco 7715473 6100098 ECOLAB

750 ML (25 US FL OZ)

Distributed by

Sysco Corporation

Manufactured by:

Ecolab - 1 Ecolab Place - St. Paul MN 55102

tel: 1 800 35 CLEAN (352 5326)

(c) 2021 Ecolab USA Inc - All rights reserved

Made in U.S.A.

representative labelrepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN10
1038855KEYSTONE Classic 0.1 % Topical FoamPSN10
1038855benzalkonium chloride 1 MG/ML Topical Foam [Keystone]SBD10
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD10
1038799benzalkonium chloride 0.1 % Topical FoamSY10
1038855Keystone 1 MG/ML Topical FoamSY10
1038855Keystone Classic 0.1 % Topical FoamSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-359-41Keystone750 mL in 1 BOTTLE, PLASTICSOLUTION75010
47593-359-56Keystone1200 mL in 1 BOTTLE, PLASTICSOLUTION120010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-359KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]10Current NDC, Legacy NDC, 2 package rows20240321_b742f102-a60c-4ed0-8d6c-d6721c9ec5dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W76
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163026
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-35947593-359-41, 47593-359-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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.b742f102-a60c-4ed0-8d6c-d6721c9ec5dc2024-03-19WarningsExact identifier
ndc (package): 47593-359-56
ndc (package): 47593-359-41
ndc (product): 47593-359
ndc11 (package): 47593035941
ndc11 (package): 47593035956
spl id: e29e91d1-65ac-46ba-a572-465697b0f6ab
spl set id: b742f102-a60c-4ed0-8d6c-d6721c9ec5dc

Reported adverse events (FAERS/openFDA)#

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