HAND SANITIZER

Manufacturer
COMERCIAL GOURA,S. DE R.L.
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:22:08

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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. 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#

DIRECTION

DOSAGE & ADMINISTRATION SECTION

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

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.

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

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

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 SECTION

OTC - PURPOSE SECTION

Purpose

Antmicrobial

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS 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.

Store below 110°F (43°C)

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70% v/v

ASK A DOCTOR

OTC - ASK DOCTOR SECTION

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

ASK A DOCTOR

OTC - ASK DOCTOR SECTION

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

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.

WARNING

WARNINGS SECTION

Warnings

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

PACKAGE LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mL english JPG2LABEL 250 mL english JPG2LABEL 500 mL AMDAYLABEL 500 mL AMDAYLABEL 1000 mL JPG englishLABEL 1000 mL JPG englishLABEL 4000 mL FINALLABEL 4000 mL FINAL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78501-1000-42022-01-28C16284748780-1d6a99b39-abce-a426-e053-dadaa90af4c2HAND SANITIZER
78501-1000-52022-01-28C16284748780-1d6a99b39-abce-a426-e053-dadaa90af4c2HAND SANITIZER
78501-1000-62022-01-28C16284748780-1d6a99b39-abce-a426-e053-dadaa90af4c2HAND SANITIZER
78501-1000-72022-01-28C16284748780-1d6a99b39-abce-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78501-1000-4HAND SANITIZER250 mL in 1 BOTTLEGEL2503
78501-1000-5HAND SANITIZER500 mL in 1 BOTTLEGEL5003
78501-1000-6HAND SANITIZER1000 mL in 1 BOTTLEGEL10003
78501-1000-7HAND SANITIZER4000 mL in 1 BOTTLEGEL40003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78501-1000HAND SANITIZER (ALCOHOL) GEL [COMERCIAL GOURA,S. DE R.L.]3Legacy NDC, 4 package rows20200722_a69ab8dc-1009-7639-e053-2995a90aadb7.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
78501-100078501-1000-4, 78501-1000-5, 78501-1000-6, 78501-1000-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
aa598b34-5486-d28a-e053-2a95a90ad5fda69ab8dc-1009-7639-e053-2995a90aadb72020-07-13WarningsExact identifier
spl id: aa598b34-5486-d28a-e053-2a95a90ad5fd
spl set id: a69ab8dc-1009-7639-e053-2995a90aadb7

Reported adverse events (FAERS/openFDA)#

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