FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Aventi Medical, LLC
Effective date
2020-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For handwashing to decrease bacteria on the skin.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Storage and handling

Store under 105 o F

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

   Antiseptic

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or ​flame.  For external use only.

When using this product

OTC - WHEN USING SECTION

Do not use in eyes.  In case of contact with eyes, rinse with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develop and persist.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

Store under 105 oF

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Package Labeling: 1000L, 77811-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10001000

Package Labeling: 3785mL, 77811-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

37853785

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
77811-001-012021-07-23C16284748780-1c7ccaba7-22b3-fd44-e053-dadaa90aa01bHand Sanitizer
77811-001-022021-07-23C16284748780-1c7ccaba7-22b3-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77811-001-01Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000001
77811-001-02Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77811-001HAND SANITIZER (ALCOHOL) GEL [AVENTI MEDICAL, LLC]1Legacy NDC, 2 package rows20200524_9dfdad4c-b8da-4c24-acc4-43a92283eac3.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77811-00177811-001-01, 77811-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHICONE92RU3N3Y1OIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
WATER059QF0KO0RIACT
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
a656b46e-f17f-78e9-e053-2a95a90a878f9dfdad4c-b8da-4c24-acc4-43a92283eac32020-05-23WarningsExact identifier
spl id: a656b46e-f17f-78e9-e053-2a95a90a878f
spl set id: 9dfdad4c-b8da-4c24-acc4-43a92283eac3

Reported adverse events (FAERS/openFDA)#

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