Label: HUMPHREYS BENDITO ALCOHOLADO- menthol liquid

  • NDC Code(s): 0219-0203-80
  • 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

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  • Ingrediente activo / Active ingredients


    Mentol / Menthol 1.25%

  • Propósito / Purpose

    Analgesia Tópica / Topical Anaglesic

  • Usos / Uses

    Para un alivio temporal de dolores musculares y dolores en las articulaciones asociados con:

    • artritis
    • moretones
    • esguinces
    • tensión
    • achaques de espalda

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • bruises
    • sprains
    • strains
    • simple backache
  • Advertencias / Warnings

    Para uso externo solamente. Evite el contacto con los ojos o las membranas mucosas. Si la condición empeora o los síntomas persisten por más de 7 dias, o si se aliviany retoman días después, interrumpa el uso del producto y consulte a un médico.

    For external use only. Avoid contact with eyes or mucous membranes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

  • DO NOT USE

    No use este producto si su piel es sensible al aceite de menta-verde (salicilato de metilo). No aplique a heridas ni a la piel maltratada. No ponga un vendaje muy apretado.
    Do not use if skin is sensitive to oil of wintergreen (methylsalicylate). Do not apply to wounds or damaged skin. Do not bandage tightly.

  • KEEP OUT OF REACH OF CHILDREN

    Mantenga fuera del alcance de niños. Si se ingiere, consiga asistencia médica o llame al Centro de Control de Venenos inmediatamente.
    Keep out of the reach of children. If swallowed,get medical help or contact a Poison Control Center right away

  • USER SAFETY WARNINGS

    Inflamable. Mantenga alejado del fuego, chispas y superficies calientes.
    Flammable keep away from fire, sparks and heated surfaces.

  • Instrucciones / Directions

    Adultos y niños de 2 años en adelante: Aplique sobre la zona afectada no más de 3 ó 4 veces al dia. Niños menores de 2 años en edad: consulte a un médico.
    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • Ingredientes inactivos / Inactive ingredients

    camphor, eucalyptol, FDC blue #1, FDC yellow #5, isopropyl alcohol, methyl salicylate, and purified water

  • Otra información / Other information

    Almacene debajo de 30C / Store below 86F

  • QUESTIONS

    Distribuido por / Dist. by:

    Humphreys Pharmacal, Inc.
    East Hampton, CT 06424
    Made in USA

    www.humphreysusa.com

  • PRINCIPAL DISPLAY PANEL

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



    HUMPHREYS

    BENDITO
    ALCOHOLADO

    Analgesia Tópica   /   Topical Anaglesic



    REFRESCA - CALMA - PENETRA


    Bendito Label FB




  • INGREDIENTS AND APPEARANCE
    HUMPHREYS BENDITO ALCOHOLADO 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0219-0203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0219-0203-80237 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 FINALpart34801/11/1972
    Labeler - Humphreys Pharmacal, Incorporated (124620340)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Distilling Inc.065524738MANUFACTURE(0219-0203)
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