FDA.reportPublic FDA data

HAND SANITIZER GEL 250 mL

Manufacturer
Ignacio Reyes González
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:31

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

DIRECTIONS OF DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

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

Supervise children under 6 years of age when using this product to avoid swallowing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

Supervise children under 6 years of age when using this product to avoid swallowing.

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.

ANTIMICROBIAL

OTC - PURPOSE SECTION

Antimicrobial

WARNINGS

WARNINGS SECTION

Warnings

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient.

Ethyl Alcohol 70%

HAND SANITIZER GEL PRINCIPAL DISPLAY LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mLLABEL 250 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77196-003-012022-01-28C16284748780-1d6a99b39-58d2-a426-e053-dadaa90af4c2HAND SANITIZER GEL 250 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77196-003-01HAND SANITIZER250 mL in 1 BOTTLEGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77196-003HAND SANITIZER (ALCOHOL) GEL [IGNACIO REYES GONZÁLEZ]1Legacy NDC, 1 package rows20200525_a6375d4c-39f7-f091-e053-2a95a90a75a0.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
77196-00377196-003-01

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
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT

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
a6375d4c-39f8-f091-e053-2a95a90a75a0a6375d4c-39f7-f091-e053-2a95a90a75a02020-05-22WarningsExact identifier
spl id: a6375d4c-39f8-f091-e053-2a95a90a75a0
spl set id: a6375d4c-39f7-f091-e053-2a95a90a75a0

Reported adverse events (FAERS/openFDA)#

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