Humphreys Bendito Alcoholado
FDA Label NDC 0219-0203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humphreys Pharmacal, Incorporated for the product Humphreys Bendito Alcoholado (NDC 0219-0203). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding ingrediente activo / active ingredients, propósito / purpose, usos / uses, advertencias / warnings, otc - do not use, otc - keep out of reach of children, user safety warnings, instrucciones / directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Ingrediente Activo / Active Ingredients

→ Propósito / Purpose

→ Usos / Uses

→ Advertencias / Warnings

→ Otc - Do Not Use

→ Otc - Keep Out Of Reach Of Children

→ User Safety Warnings

→ Instrucciones / Directions

→ Ingredientes Inactivos / Inactive Ingredients

→ Otra Información / Other Information

→ Otc - Questions

→ Package Label.principal Display Panel

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

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.

Otc - 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.

Otc - 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.