FDA.reportPublic FDA data

EPH Labs Hand Sanitizer

Manufacturer
EPH Laboratories
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:47

Label at a glance#

ProductEPH Labs Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• To decrease bacteria and germs on skin • Recommended for repeated use.

Dosage and administration

• Wet Hands throughly with product and allow to dry without wiping. • For children under 6, use only under adult supervision. • Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer Triethanolamine, Glycerin,Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Uses

INDICATIONS & USAGE SECTION

• To decrease bacteria and germs on skin • Recommended for repeated use.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet Hands throughly with product and allow to dry without wiping. • For children under 6, use only under adult supervision. • Not recommended for infants.

Warnings

WARNINGS SECTION

For external use only-hands. Flammable. Keep away from heat and flame.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation develops.

When using this product:

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. • Do not inhale or ingest. • Avoid contact with broken skin.

Other Information

SPL UNCLASSIFIED SECTION

• Do not store above 105˚F
• May discolour some fabrics
• Harmful to wood finishes and plastics.

Package Labeling: 3786ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 300ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79759-002-012021-07-23C16284748780-1c7ccaba7-26dc-fd44-e053-dadaa90aa01bEPH Labs Hand Sanitizer
79759-002-022021-07-23C16284748780-1c7ccaba7-26dc-fd44-e053-dadaa90aa01bEPH Labs Hand Sanitizer
79759-002-032021-07-23C16284748780-1c7ccaba7-26dc-fd44-e053-dadaa90aa01bEPH Labs Hand Sanitizer
79759-002-042021-07-23C16284748780-1c7ccaba7-26dc-fd44-e053-dadaa90aa01bEPH Labs Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79759-002-01EPH Labs Hand Sanitizer3786 mL in 1 BOTTLEGEL37861
79759-002-02EPH Labs Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79759-002-03EPH Labs Hand Sanitizer300 mL in 1 BOTTLEGEL3001
79759-002-04EPH Labs Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79759-002EPH LABS HAND SANITIZER (ALCOHOL) GEL [EPH LABORATORIES]1Legacy NDC, 4 package rows20200728_94d4365d-3cac-4572-8a9d-081aa7c372b5.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79759-00279759-002-01, 79759-002-02, 79759-002-03, 79759-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
ab6cc43f-185b-f69e-e053-2995a90ab73d94d4365d-3cac-4572-8a9d-081aa7c372b52020-07-27WarningsExact identifier
spl id: ab6cc43f-185b-f69e-e053-2995a90ab73d
spl set id: 94d4365d-3cac-4572-8a9d-081aa7c372b5

Reported adverse events (FAERS/openFDA)#

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