Hand Sanitizer

Manufacturer
FAZ Marketing
Effective date
2020-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

■ Hand sanitizer to help reduce bacteria on the skin * Recommended for repeated use/Antiséptico para las manos para disminuir la cantidad de bacteria en la piel * Recomendado para uso frecuente.

Dosage and administration

■Place enough product in your palm to thoroughly cover your hands. * Rub hands together briskly until dry. * Children under 6 years of age should be supervised when using this product/* Aplique suficiente cantidad del producto en la palma de la mano para cubrir completamente. * Frotar las manos vigorosamente hasta que se sequen. * El uso de este producto por niños menores de 6 años deberá ser supervisado.

Label contents#

Full prescribing information#

Active Ingredient/Ingrediente Activo

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol/Aclohol Etílico 70%

Purpose/Propósito

OTC - PURPOSE SECTION

Antimicrobial/Amtimicrobiano

Uses/Usos

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce bacteria on the skin * Recommended for repeated use/Antiséptico para las manos para disminuir la cantidad de bacteria en la piel * Recomendado para uso frecuente.

Warnings/Advertencias

WARNINGS SECTION

Flammable. Keep away from fire or flame / Inflamable. Manterner alejado del fuego o llamas.

For external use only / Solo para uso externo

When using this product/Al utilizar este producto

OTC - WHEN USING SECTION

■do not use in or near eyes. In case of contact, rinse eyes thoroughly with water./evitar el contacto con los ojos o la zona alrededor de los ojos. En caso de contacto enjuagar completamente los ojos con agua.

Stop use and ask a doctor if/Suspenda su uso y consulte a un médico

OTC - STOP USE SECTION

■ if irritation or rash appears and lasts/si aparece y dura irritación o sarpullido.

Keep out of reach of children/Mantener fuera del alcance de los niños.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or Poison Control Center right away./En caso de ingestión, de inmediato acudir a un médico o ponerse en contacto con un Centro de Control de Venenos.

Directions/Modo de uso

DOSAGE & ADMINISTRATION SECTION

■Place enough product in your palm to thoroughly cover your hands. * Rub hands together briskly until dry. * Children under 6 years of age should be supervised when using this product/* Aplique suficiente cantidad del producto en la palma de la mano para cubrir completamente. * Frotar las manos vigorosamente hasta que se sequen. * El uso de este producto por niños menores de 6 años deberá ser supervisado.

Inactive Ingredients/Ingredientes inactivos

INACTIVE INGREDIENT SECTION

Distilled water, carbopol, triethanolamine, glycerin/Agua destilada, carbopol, trietanolamina, glicerina.

Other information/Otra Información

SPL UNCLASSIFIED SECTION

■ Store at 68° to 77° F (20° - 25° C). * May discolor certain fabrics. / Almacene el producto a 68° to 77° F (20° - 25° C). * Puede decolorar ciertas telas.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50061-002-02Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
50061-002-08Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
50061-002-16Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001
50061-002-33Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50061-002HAND SANITIZER (ALCOHOL) GEL [FAZ MARKETING]1Legacy NDC, 4 package rows20200630_a93fcebf-9e68-2ac5-e053-2a95a90aed69.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
50061-00250061-002-08, 50061-002-02, 50061-002-16, 50061-002-33

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
a93fce56-4e22-34eb-e053-2a95a90a73ffa93fcebf-9e68-2ac5-e053-2a95a90aed692020-06-29WarningsExact identifier
spl id: a93fce56-4e22-34eb-e053-2a95a90a73ff
spl set id: a93fcebf-9e68-2ac5-e053-2a95a90aed69

Reported adverse events (FAERS/openFDA)#

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