FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Hanover Pen Corp dba HPC Global | Safetec of America, Inc.
Effective date
2012-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:59

Label at a glance#

ProductHand Sanitizer
Active ingredientAlcohol
Label structure10 sections

Indications and uses

For handwashing to decrease bacteria on skin without soap and water. Recommended for repeated use.

Dosage and administration

wet hands throughly with product allow to dry without wiping children under six should be supervised while using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 66.5 percent

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin without soap and water.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

Do not use in the eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation of redness develops and persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wet hands throughly with product

allow to dry without wiping

children under six should be supervised while using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, D and C number 5, D and C yellow number 10, fragrance, purified water, triethanolamine

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front Label

NDC 51811-374-14

Hand Sanitizer - Fresh

4 FL OZ (118ML)

Back Label(Drug Facts)


Hand Sanitizer - Fresh

Distributed by
HPC Global, Hanover PA, 17331
Made in USA

Image Drug Facts LabelImage Drug Facts Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616762ethanol 66.5 % Topical GelPSN1
616762ethanol 0.665 ML/ML Topical GelSCD1
616762ethanol 66.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51811-374-142020-01-31C16284748780-19d75b9d0-13ae-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51811-374-14Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51811-374HAND SANITIZER (ALCOHOL) GEL [HANOVER PEN CORP DBA HPC GLOBAL]1Legacy NDC, 1 package rows20120222_60a618ea-e18c-4d55-a125-246f0fc437c7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1
AloeINACTIVE INGREDIENTV5VD430YW91
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51811-37451811-374-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Trolamine9O3K93S3TKIACT
AloeV5VD430YW9IACT
Water059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TrolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact 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
TrolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact 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
TrolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact 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
88e2dfa9-05e6-4130-84b2-2c578410519960a618ea-e18c-4d55-a125-246f0fc437c72012-02-01WarningsExact identifier
spl id: 88e2dfa9-05e6-4130-84b2-2c5784105199
spl set id: 60a618ea-e18c-4d55-a125-246f0fc437c7

Reported adverse events (FAERS/openFDA)#

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