FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V.
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:18

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Dosage and administration

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Label contents#

Full prescribing information#

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Directions

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

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

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.

PURPOSE

OTC - PURPOSE SECTION

Purpose. Antmicrobial

WARNINGS AND PRECAUTIONS SECTION

Warnings

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

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

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.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70% v/v

WARNINGS

WARNINGS SECTION

Warnings

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

Other information

Store below 110°F (43°C)

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mL english JPG2LABEL 250 mL english JPG2LABEL 500 mL jpg englishLABEL 500 mL jpg englishLABEL 1000 mL JPG englishLABEL 1000 mL JPG englishLABEL 4000 mL FINAL jpgLABEL 4000 mL FINAL jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78770-3000-32022-01-28C16284748780-1d6a99b39-f483-a426-e053-dadaa90af4c2a74f5b04-841d-8b5c-e053-2a95a90abcf2
78770-3000-42022-01-28C16284748780-1d6a99b39-f483-a426-e053-dadaa90af4c2a74f5b04-841d-8b5c-e053-2a95a90abcf2
78770-3000-52022-01-28C16284748780-1d6a99b39-f483-a426-e053-dadaa90af4c2a74f5b04-841d-8b5c-e053-2a95a90abcf2
78770-3000-62022-01-28C16284748780-1d6a99b39-f483-a426-e053-dadaa90af4c2a74f5b04-841d-8b5c-e053-2a95a90abcf2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78770-3000-3HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78770-3000-4HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78770-3000-5HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
78770-3000-6HAND SANITIZER4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78770-3000HAND SANITIZER (ALCOHOL) GEL [GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V.]1Legacy NDC, 4 package rows20200606_a74f5b04-841d-8b5c-e053-2a95a90abcf2.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
78770-300078770-3000-3, 78770-3000-4, 78770-3000-5, 78770-3000-6

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
a74f5b04-841e-8b5c-e053-2a95a90abcf2a74f5b04-841d-8b5c-e053-2a95a90abcf22020-06-05WarningsExact identifier
spl id: a74f5b04-841e-8b5c-e053-2a95a90abcf2
spl set id: a74f5b04-841d-8b5c-e053-2a95a90abcf2

Reported adverse events (FAERS/openFDA)#

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