Humphreys Bendito Alcoholado

Description

HUMPHREYS BENDITO ALCOHOLADO is a topical analgesic formulated to provide localized pain relief. This product is designed to refresh, calm, and penetrate the skin, delivering effective analgesic properties. Its formulation is intended for use in managing discomfort associated with various conditions, ensuring targeted relief at the site of application.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, bruises, sprains, strains, and simple backache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

Use is contraindicated in patients with a known sensitivity to oil of wintergreen (methylsalicylate) due to the risk of adverse reactions. Application to wounds or damaged skin is contraindicated to prevent further irritation and complications. Additionally, tight bandaging is contraindicated as it may exacerbate local irritation or impede circulation.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

General precautions must be observed. This product should not be used if the skin is sensitive to oil of wintergreen (methylsalicylate). Application to wounds or damaged skin is contraindicated. Additionally, tight bandaging of the area where the product is applied should be avoided.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

If the condition worsens or symptoms persist beyond 7 days, or if there is a recurrence of symptoms after initial improvement, the use of this product should be stopped, and a healthcare provider should be contacted for further evaluation and guidance.

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to avoid contact with the eyes or mucous membranes to prevent potential adverse reactions.

In clinical practice, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended to discontinue use of the product and consult a healthcare professional. These precautions are essential to ensure patient safety and to mitigate any potential risks associated with the use of this product.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Humphreys Bendito Alcoholado (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to keep the product out of the reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient stabilizes or until further medical assistance is available.

In summary, while specific overdosage information is not provided, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center if the medication is swallowed. This information is vital for ensuring patient safety and preventing potential harm.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures below 30°C (86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Humphreys Bendito Alcoholado, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)