FDA.reportPublic FDA data

KE-53PS Gel Hand Sanitizer

Manufacturer
Kinzua Environmental Inc. | Canberra Corporation
Effective date
2010-05-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:25:06

Label at a glance#

ProductKE-53PS Hand Sanitizer
Active ingredientethanol
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Ethanol (60% v/v)

OTC - PURPOSE SECTION

Purpose:

Anti-Microbial Hand Sanitizer

INDICATIONS & USAGE SECTION

Uses

  • Helps reduce bacteria that potentially can cause disease
  • Helps prevent cross contamination by hand contact
  • Recommended for repeated use

WARNINGS SECTION

Warnings

  • For external use only
  • Flammable, keep away from fire, heat, or flame
  • Keep out of reach of children.
  • Do not use near eyes
  • In case of eye contact flush with water for 15 minutes
  • If irritation persists stop use of product and get medical attention
  • In case of accidental ingestion seek medical attention or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Use no water or towels
  • Apply appropriate amount of product to palm of hand
  • Rub until hands are completely covered
  • Agitate lightly until dry
  • Let air dry for 15 seconds
  • Do not rinse or wipe with towel.

SPL UNCLASSIFIED SECTION

Other Information

  • Store in a cool dry place below 104° F.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

Principal Display Panel – Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KE-53PS
Gel Hand Sanitizer

  • Enhanced with Moisturizers
  • Kills disease causing germs within seconds
  • Effective against MRSA, VRE, E. coli (0157:H7) Staphylococcus, Streptococcus and other organisms
  • Assists with OSHA Bloodborne Pathogen Standard Compliance

For Hospital and Professional Use Only
See Drug Facts panel for additional information

12-266-1362
Manufactured for:
KINZUA ENVIRONMENTAL, Inc.
1176 E. 38th. • CLEVELAND, OH 44114
1-800-233-5079

Principal Display Panel – Bottle Label
Principal Display Panel – Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN3
581658ethanol 0.6 ML/ML Topical GelSCD3
581658ethanol 60 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64121-515-272019-10-21C16284748780-1956f9ecf-bbf8-621f-e053-dbdaa90a74adKE-53PS Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64121-515-27KE-53PS Hand Sanitizer118 mL in 1 BOTTLEGEL1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64121-515KE-53PS HAND SANITIZER (ETHANOL) GEL [KINZUA ENVIRONMENTAL INC. ]3Legacy NDC, 1 package rows20100708_f3848a8b-eec3-4a10-8c0f-1912adfeebd4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ethanolACTIVE INGREDIENT3K9958V90M3
ethanolACTIVE MOIETY3K9958V90M3
aloeINACTIVE INGREDIENTV5VD430YW93
carbomer homopolymer type CINACTIVE INGREDIENT4Q93RCW27E3
trolamineINACTIVE INGREDIENT9O3K93S3TK3
waterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64121-51564121-515-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ethanol3K9958V90MACTIB
water059QF0KO0RIACT
carbomer homopolymer type C4Q93RCW27EIACT
aloeV5VD430YW9IACT
trolamine9O3K93S3TKIACT

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 · 31 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TRANSDERMAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 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
24b35ee1-549e-4a6c-94f0-2c9a5651a404f3848a8b-eec3-4a10-8c0f-1912adfeebd42010-05-21WarningsExact identifier
spl id: 24b35ee1-549e-4a6c-94f0-2c9a5651a404
spl set id: f3848a8b-eec3-4a10-8c0f-1912adfeebd4

Reported adverse events (FAERS/openFDA)#

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