Keystone

Manufacturer
Ecolab Inc.
Effective date
2024-03-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:09:57

Label at a glance#

ProductKeystone
Active ingredientTRICLOSAN
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

wet skins and apply a small amount on hands an forearms scrub well, rinse thoroughly and dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Triclosan 0.3%

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

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

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • 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 skins and apply a small amount on hands an forearms
  • scrub well, 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), potassium cocoate, alcohol, sodium laureth sulfate, hexylene glycol, boric acid, cocamidopropyl PG-dimonium chloride phosphate, tetrasodium EDTA, cocamine oxide, fragrance, PEG-75 lanolin, methylparaben, propylparaben, aloe barbadensis leaf juice, FD&C blue 1

OTC - QUESTIONS SECTION

Questions?  call 1.800.35.CLEAN (352.5326)

Principal display panel and representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KEYSTONE

ANTIBACTERIAL FOAM HANDSOAP

Triclosan 0.3%

SYSCO 0281531

6100517 ECOLAB

Net Contents:  1200 mL (40.6 US fl oz)

750767/5401/0420

Distributed by

Sysco Corporation

Manufactured by

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

tel: 1 800 35 CLEAN (352 5326)

© 2020 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
260054triclosan 0.3 % Medicated Liquid SoapPSN5
260054triclosan 3 MG/ML Medicated Liquid SoapSCD5
260054triclosan 0.3 % Foaming Medicated Hand SoapSY5
260054triclosan 0.3 % Medicated Liquid SoapSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-341-41Keystone750 mL in 1 BOTTLE, PLASTICSOLUTION7505
47593-341-56Keystone1200 mL in 1 BOTTLE, PLASTICSOLUTION12005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-341KEYSTONE (TRICLOSAN) SOLUTION [ECOLAB INC.]5Current NDC, Legacy NDC, 2 package rows20240320_0e7ccbbe-0cda-4d8d-8ded-4b259ead1daa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5X1
TRICLOSANACTIVE MOIETY4NM5039Y5X1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOEINACTIVE INGREDIENTV5VD430YW91
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM41
COCAMINE OXIDEINACTIVE INGREDIENTQWA2IZI6FI1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TB1
POTASSIUM COCOATEINACTIVE INGREDIENTF8U72V8ZXP1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-34147593-341-41, 47593-341-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii+route
15 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route
9 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii+route
15 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii+route
15 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 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
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii+dosage form
15 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route
9 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii+route
15 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 BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii+dosage form
15 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii+route
15 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii+dosage form
15 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact 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
KeystoneTRICLOSANEcolab Inc.0e7ccbbe-0cda-4d8d-8ded-4b259ead1daa2024-03-18WarningsExact identifier
ndc (package): 47593-341-41
ndc (package): 47593-341-56
ndc (product): 47593-341
ndc11 (package): 47593034141
ndc11 (package): 47593034156
spl id: b0dbaf7f-4ca9-4589-93aa-175b2dc677ff
spl set id: 0e7ccbbe-0cda-4d8d-8ded-4b259ead1daa

Reported adverse events (FAERS/openFDA)#

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