HUMPHREYS BENDITO ALCOHOLADO- menthol liquid 
Humphreys Pharmacal, Incorporated

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.

----------

Monografía / Drug Facts

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:

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

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.

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.

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

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

Distribuido por / Dist. by:

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

www.humphreysusa.com

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




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)

Revised: 12/2020
Document Id: d9506518-f00e-4668-a65a-22b870bf0881
Set id: f3e86cb8-2da5-4f6c-8672-7c600f84a7a0
Version: 3
Effective Time: 20201221
 
Humphreys Pharmacal, Incorporated