FDA.reportPublic FDA data

HAND SANITIZER GEL

Manufacturer
FARMIRAL, S.A. DE C.V.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:52

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS

INDICATIONS & USAGE SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70% v/v…

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNING

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL HAND SANITIZER 250 mLLABEL HAND SANITIZER 250 mLLABEL HAND SANITIZER 500 mLLABEL HAND SANITIZER 500 mLLABEL 1000 mL ENGLISHLABEL 1000 mL ENGLISH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676753003584GTIN-13: 0676753003584
EAN-13: 0676753003584
GTIN-12: 676753003584
UPC-A: 676753003584
GTIN storage (14 digits): 00676753003584		LABEL HAND SANITIZER 500 mL.jpg
BarcodeEAN-130676753003591GTIN-13: 0676753003591
EAN-13: 0676753003591
GTIN-12: 676753003591
UPC-A: 676753003591
GTIN storage (14 digits): 00676753003591		LABEL HAND SANITIZER 250 mL.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78814-6000-12022-01-28C16284748780-1d6a99b39-5a35-a426-e053-dadaa90af4c2HAND SANITIZER GEL
78814-6000-22022-01-28C16284748780-1d6a99b39-5a35-a426-e053-dadaa90af4c2HAND SANITIZER GEL
78814-6000-32022-01-28C16284748780-1d6a99b39-5a35-a426-e053-dadaa90af4c2HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78814-6000-1HAND SANITIZER250 mL in 1 BOTTLEGEL2503
78814-6000-2HAND SANITIZER500 mL in 1 BOTTLEGEL5003
78814-6000-3HAND SANITIZER1000 mL in 1 BOTTLEGEL10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78814-6000HAND SANITIZER (ALCOHOL) GEL [FARMIRAL, S.A. DE C.V.]3Legacy NDC, 3 package rows20200610_a78d252d-f819-c57c-e053-2a95a90a2e0a.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
78814-600078814-6000-1, 78814-6000-2, 78814-6000-3

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
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT

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
a7b3b837-a6eb-9c69-e053-2a95a90a6b66a78d252d-f819-c57c-e053-2a95a90a2e0a2020-06-10WarningsExact identifier
spl id: a7b3b837-a6eb-9c69-e053-2a95a90a6b66
spl set id: a78d252d-f819-c57c-e053-2a95a90a2e0a

Reported adverse events (FAERS/openFDA)#

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