HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FAZ Marketing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient/Ingrediente Activo

Ethyl Alcohol/Aclohol Etílico 70%

Purpose/Propósito

Antimicrobial/Amtimicrobiano

Uses/Usos

■ 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

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

■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

■ 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.

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

■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

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

Other information/Otra Información

■ 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

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50061-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50061-002-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2020
2	NDC: 50061-002-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2020
3	NDC: 50061-002-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2020
4	NDC: 50061-002-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/22/2020

Labeler - FAZ Marketing (625680645)