FDA.reportPublic FDA data

Envirokleen Instant Hand Sanitizer

Manufacturer
EnviroKleen LLC | Canberra Corporation
Effective date
2011-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:48

Label at a glance#

ProductEnvirokleen Instant Hand Sanitizer
Active ingredientalcohol
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethanol (60% v/v)

Purpose:

OTC - PURPOSE SECTION

Anti-Microbial Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire, heat, or flame

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other Information:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECS Envirokleen Instant Hand Sanitizer

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

See Drug Facts panel for additional information.
For Hospital And Professional Use Only
Envirokleen, LLC
3313 South Arlington Avenue
Indianapolis, Indiana 46203
Phone 317-352-1941 Fax 317-352-1946
Website: www.ecsenvirokleen.com

“Environmental Cleaning Solutions”

Align the half moon ears (round side out) with
the slots of the dispenser's lower docking area.
Press top and bottom of tube firmly into place.

KEEP OUT OF REACH OF CHILDREN.Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN1
581658ethanol 0.6 ML/ML Topical GelSCD1
581658ethanol 60 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50112-515-802019-10-29C16284748780-1960f7f55-c050-8e05-e053-dbdaa90a074aECS Envirokleen Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50112-515-80Envirokleen Instant Hand Sanitizer800 mL in 1 BOTTLEGEL8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50112-515ENVIROKLEEN INSTANT HAND SANITIZER (ALCOHOL) GEL [ENVIROKLEEN LLC]1Legacy NDC, 1 package rows20110419_fae79b5c-b3dc-4f7c-851c-0430af05f346.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
alcoholACTIVE MOIETY3K9958V90M1
aloeINACTIVE INGREDIENTV5VD430YW91
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27E1
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

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
50112-51550112-515-80

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
alcohol3K9958V90MACTIB
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
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, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %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
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 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
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact 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
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 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
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact 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 / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / 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
250723d7-ec8a-4f2b-a09c-ffda6b655944fae79b5c-b3dc-4f7c-851c-0430af05f3462011-03-09WarningsExact identifier
spl id: 250723d7-ec8a-4f2b-a09c-ffda6b655944
spl set id: fae79b5c-b3dc-4f7c-851c-0430af05f346

Reported adverse events (FAERS/openFDA)#

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