FDA.reportPublic FDA data

Antiseptic Hand Sanitizer Ethyl Alcohol

Manufacturer
Corporacion Saint Germain
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:13

Label at a glance#

ProductAntiseptic Hand Sanitizer Ethyl Alcohol
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  •  in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

  • Store below 106 °F (41 °C). May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, isopropyl alcohol, carbomer, triethanolamine.

Questions or comments?

OTC - QUESTIONS SECTION

+1 (305) 517-7739

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
79036-000-012022-01-28C16284748780-1d6a99b39-ab37-a426-e053-dadaa90af4c2Antiseptic Hand Sanitizer Ethyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79036-000-01Antiseptic Hand Sanitizer Ethyl Alcohol3790 mL in 1 BOTTLEGEL37901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79036-000ANTISEPTIC HAND SANITIZER ETHYL ALCOHOL (ALCOHOL) GEL [CORPORACION SAINT GERMAIN]1Legacy NDC, 1 package rows20200714_aa57e4a4-b054-1973-e053-2995a90a64ba.zip

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
79036-00079036-000-01

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
aa57e4a4-b055-1973-e053-2995a90a64baaa57e4a4-b054-1973-e053-2995a90a64ba2020-07-13WarningsExact identifier
spl id: aa57e4a4-b055-1973-e053-2995a90a64ba
spl set id: aa57e4a4-b054-1973-e053-2995a90a64ba

Reported adverse events (FAERS/openFDA)#

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