FDA.reportPublic FDA data

PROCLEAN

Manufacturer
Ecolab Inc.
Effective date
2024-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:36

Label at a glance#

ProductPROCLEAN
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 physician 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, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquaternium-7, fragrance, potassium hydroxide, blue 1

OTC - QUESTIONS SECTION

Questions? call 1-866-781-8787

Representative Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROCLEAN

ADVANCED

ANTIBACTERIAL

HAND SOAP

Antibacterial liquid hand soap

Active ingredient: Benzalkonim chloride 0.5%

6102017

3.78 L (1 US GAL)

For more ingredient information visit: www.shamrockfoodservice.com/proclean

This product may be patented

For questions or comments, call 1-866-444-7450.

Manufactured by

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

© 2018  Ecolab USA Inc. · All rights reserved

774470/5400/1018

Distributed by Shamrock Foods

Phoenix, AZ

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-602-11PROCLEAN3780 mL in 1 BOTTLE, PLASTICSOLUTION37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-602PROCLEAN (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]2Current NDC, Legacy NDC, 1 package rows20240806_60da90e4-3467-4aea-9c44-09a9ef718995.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
47593-60247593-602-11

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 PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
MYRISTIC DIISOPROPANOLAMIDE17DN142CTKIACT
MYRISTAMINE OXIDEJ086PM3RRTIACT
METHYL GLUCETH-20J3QD0LD11PIACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
ALCOHOL3K9958V90MIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
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
PROCLEANBENZALKONIUM CHLORIDEEcolab Inc.60da90e4-3467-4aea-9c44-09a9ef7189952024-08-05WarningsExact identifier
ndc (package): 47593-602-11
ndc (product): 47593-602
ndc11 (package): 47593060211
spl id: 47afa609-ac81-43a4-bdd3-b8bf76d7e2da
spl set id: 60da90e4-3467-4aea-9c44-09a9ef718995

Reported adverse events (FAERS/openFDA)#

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