Drug Facts

Manufacturer
Ecolab Inc.
Effective date
2024-05-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:13:16

Label at a glance#

ProductEcolab Inc.
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

For handwashing to decrease bacteria on the skin

Dosage and administration

do not mix with anything except for potable water use only provided bottles for dilution and dispensing of ready-to-use product remove cap, open dispenser door, place bottle into position, and close dispenser door fill hand sanitizer bottle with solution form dispenser place bottle into a Nexa dispenser for use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.89%

Purpose

OTC - PURPOSE SECTION

Antispetic 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

  • 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 Posoin Control Center right away.

Directions: Concentrated Solution

INSTRUCTIONS FOR USE SECTION

  • do not mix with anything except for potable water
  • use only provided bottles for dilution and dispensing of ready-to-use product
  • remove cap, open dispenser door, place bottle into position, and close dispenser door
  • fill hand sanitizer bottle with solution form dispenser
  • place bottle into a Nexa dispenser for use

Directions: Ready-To-Use Solution

DOSAGE & ADMINISTRATION SECTION

  • wash hands to remove soil
  • apply sanitizer to hands
  • spread to cover hands thoroughly, rub to dry

Other information

REFERENCES SECTION

  • 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 is in the US).

INACTIVE INGREDIENT SECTION

Inactive ingredients water (aqua), propylene glycol, sodium benzoate, FD&C yellow 5, FD&C red 40

OTC - QUESTIONS SECTION

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

Principal display panel and representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECOLAB® 6100873

Concentrated Foam1.3 L (44 US FL OZ)

Active ingredient: Benzalkonium chloride, 0.89%

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 • 759250/5401/1018

representative labelrepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1604323benzalkonium Cl 0.89 % Topical FoamPSN7
1604323benzalkonium chloride 8.9 MG/ML Topical FoamSCD7
1604323benzalkonium chloride 0.89 % Topical FoamSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-512-61Ecolab Inc.2000 mL in 1 POUCHSOLUTION20007
47593-512-62Ecolab Inc.1300 mL in 1 BOTTLE, PLASTICSOLUTION13007
47593-512-94Ecolab Inc.1900 mL in 1 BOTTLE, PLASTICSOLUTION19007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-512ECOLAB INC. (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]7Current NDC, Legacy NDC, 3 package rows20240602_7873638a-afd7-4b55-bcc5-0e893a437fb3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
47593-51247593-512-61, 47593-512-62, 47593-512-94

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
16 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
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7873638a-afd7-4b55-bcc5-0e893a437fb32024-05-31WarningsExact identifier
ndc (package): 47593-512-94
ndc (package): 47593-512-62
ndc (package): 47593-512-61
ndc (product): 47593-512
ndc11 (package): 47593051262
ndc11 (package): 47593051294
ndc11 (package): 47593051261
spl id: 98ea789d-8aca-42d6-afb4-03525d8cba65
spl set id: 7873638a-afd7-4b55-bcc5-0e893a437fb3

Reported adverse events (FAERS/openFDA)#

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