Label: HUMPHREYS ALCOHOLADO MARAVILLA- alcohol liquid

  • NDC Code(s): 0219-2020-16
  • Packager: Humphreys Pharmacal, Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 21, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ingrediente activo / Active ingredient

    Alcohol etilico 70% / Ethyl alcohol 70%

  • Propósito / Purpose

    Antiséptico / Antiseptic

  • Usos / Uses

    ayuda primaria para prevenir el riesgo de la infección en:
    first aid to help prevent the risk of infection in:

    • cortadas menores / minor cuts
    • raspaduras/scrapes
    • quemaduras/burns
  • Advertencias / Warnings

    Para uso externo solamente. / For external use only.

    Inflamable, mantenga lejos de fuego y chispas/ Flammable, keep away from fire or flame

  • ASK DOCTOR


    Consulte a un médico antes de usar si usted tiene heridas profundas, una perforación, mordidas de animal o quemaduras graves / Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

  • WHEN USING

    Cuando se usa este producto / When using this product

    • que no tenga contacto con los ojos / do not get into eyes
    • que no aplique sobre áreas grandes del cuerpo / do not apply over large areas of the body
    • que no utilice más de 1 semana a menos que le indique un médico / do not use longer than 1 week unless directed by a doctor
  • STOP USE

    Descontinúe y consulte a un médico si la condición persiste o empeora
    Stop use and ask doctor if condition persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    Mantenga alejado de los niños. Si se ingiere, busque ayuda médica inmediatamente.
    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Direcciones / Directions

    Aplique sobre la piel directamente o con una gasa limpia, algodón o un bastoncillo de algodón / Apply to the skin directly or with clean gauze, cotton, or swab

  • Ingredientes inactivos / Inactive ingredients

    bay oil, denatonium benzoate, FDC blue #1, FDC red #40, FDC yellow #5, FDC yellow #6, fragrance, hamamelis virginianna, menthol, polysorbate 20, purified water, t-butyl alcohol

  • Otra información / Other information

    Almacenar por debajo de 30C. Store below 86F.

  • QUESTIONS

    Distribuido por / Dist. by:

    Humphreys Pharmacal, Inc.
    East Hampton, CT 06424

    Made in USA
    www.humphreysusa.com

  • Product Packaging

    The labels shown below represent a sample of that currently in use. Additional packaging may also be available.


    HUMPHREYS

    ALCOHOLADO MARAVILLA 70

    Antiseptic Lotion / Loción Anticeptica

    TERAPEUTICO - EFICAZ - FORMIDABLE


    Alcoholado label




  • INGREDIENTS AND APPEARANCE
    HUMPHREYS ALCOHOLADO MARAVILLA 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0219-2020
    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
    BAY OIL (PIMENTA RACEMOSA) (UNII: 3T5GC5CQ33)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0219-2020-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/1972
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A01/11/1972
    Labeler - Humphreys Pharmacal, Incorporated (124620340)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Distilling Inc.065524738MANUFACTURE(0219-2020)