Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 29, 2020

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  • 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

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50061-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50061-002-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    2NDC:50061-002-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    3NDC:50061-002-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    4NDC:50061-002-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - FAZ Marketing (625680645)
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