Gelato Anestesico Topical Gel

Description

The product is a gel formulation intended for topical application. It contains an active ingredient, the specifics of which are not provided. The formulation includes various inactive ingredients, details of which are also not specified. The gel is packaged in a manner that has not been detailed in the provided information.

Uses and Indications

This drug is indicated solely for use on the oral mucosa, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

Dosage and Administration

La cantidad necesaria debe aplicarse únicamente sobre la mucosa oral para prevenir o aliviar el dolor. Este medicamento no está indicado para su uso en niños menores de 2 años. Se recomienda a los profesionales de la salud que evalúen cuidadosamente la necesidad de este tratamiento en pacientes dentro de este grupo de edad.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

El uso de este producto conlleva importantes advertencias y precauciones que deben ser consideradas para garantizar la seguridad del paciente.

Advertencia de Metahemoglobinemia Este producto puede inducir metahemoglobinemia, una condición grave que compromete la capacidad de la sangre para transportar oxígeno. Los síntomas pueden presentarse incluso en pacientes que han utilizado el producto previamente sin complicaciones. Se debe interrumpir el uso de inmediato y buscar atención médica si se observan los siguientes signos en el paciente o en un niño bajo su cuidado: piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, y fatiga o falta de energía.

Alerta de Alergia Este producto está contraindicado en pacientes con antecedentes de reacciones alérgicas a anestésicos locales, incluyendo procaína, butacaína, benzocaína u otros anestésicos de tipo "caína".

Uso y Duración No se debe utilizar este producto por más de 7 días a menos que sea indicado por un médico. Si los síntomas de dolor en la boca no mejoran en este período, o si la irritación, el dolor o el enrojecimiento persisten o empeoran, o si se presenta hinchazón, sarpullido o fiebre, se debe consultar a un médico de inmediato. Este producto no está indicado para la dentición y no debe ser administrado a niños menores de 2 años.

Precauciones durante el Uso Se debe evitar el contacto con los ojos. En caso de contacto accidental, se recomienda enjuagar con abundante agua fresca.

Dosis Recomendada Es crucial no exceder la dosis recomendada. En caso de ingestión accidental de una cantidad superior a la indicada para el tratamiento del dolor, se debe buscar atención médica o contactar a un Centro de Control de Envenenamiento de inmediato.

Embarazo y Lactancia Las mujeres embarazadas o en periodo de lactancia deben consultar a un médico antes de utilizar este producto.

Side Effects

The use of this product may lead to serious adverse reactions, including metahemoglobinemia, a condition that significantly reduces the amount of oxygen transported in the blood. This condition can occur even in patients who have previously used the product without issue. Patients should discontinue use and seek immediate medical attention if they or a child under their care exhibit symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, difficulty breathing, dizziness or lightheadedness, and fatigue or lack of energy.

Additionally, there is a warning regarding the use of this product in patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics. Such patients should avoid using this product due to the risk of allergic reactions.

Patients are advised not to use the product for more than 7 days unless directed by a healthcare professional. If symptoms of oral pain do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should consult their physician immediately. The product is also contraindicated for use in teething and in children under 2 years of age.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Gelato Anestesico Topical Gel (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

El medicamento no debe ser utilizado en niños menores de 2 años. Se debe mantener fuera del alcance de los niños.

Se ha emitido una advertencia sobre el riesgo de metahemoglobinemia. Se debe interrumpir el uso y buscar atención médica inmediata si se observa que el paciente, ya sea un niño o un adulto bajo su cuidado, presenta síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, fatiga o falta de energía.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients or those who are breastfeeding should consult a healthcare professional prior to use. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

There is no relevant information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function in the provided text. Therefore, no specific recommendations or precautions can be made for this patient population.

Hepatic Impairment

There is no relevant information regarding hepatic impairment, dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations or restrictions are provided for this patient population.

Overdosage

El uso de este medicamento debe adherirse estrictamente a la dosis recomendada. Se advierte a los profesionales de la salud que, en caso de ingestión accidental de una cantidad superior a la indicada para el tratamiento del dolor, se debe buscar asistencia médica de inmediato.

Es fundamental contactar a un Centro de Control de Envenenamiento para recibir orientación adecuada sobre la gestión de la sobredosis. La intervención oportuna es crucial para minimizar los riesgos asociados con la sobredosis y garantizar la seguridad del paciente.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

The use of this product has been associated with reports of methemoglobinemia, a serious condition that can reduce the amount of oxygen transported in the blood. This adverse event may occur even in individuals who have previously used the product without issue. Users are advised to discontinue use and seek immediate medical attention if symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, difficulty breathing, dizziness or lightheadedness, fatigue, or lack of energy are observed in themselves or in children under their care.

Additionally, there is a warning regarding the use of this product in patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics.

It is recommended that the product not be used for more than 7 days unless directed by a healthcare professional. Users should consult their physician immediately if oral pain symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Patient Counseling

Advise patients to keep this medication out of the reach of children. It is important to emphasize the potential risks associated with accidental ingestion or misuse by children. Encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in configurations that adhere to the National Drug Code (NDC) standards. It should be stored at a temperature not exceeding 30°C. Care must be taken to protect the product from freezing to maintain its integrity and efficacy. Proper storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

The route of administration for the medication is dental. Clinicians should advise patients to avoid contact with the eyes; in the event of contact, they should rinse thoroughly with fresh water. Patients are also cautioned to seek medical assistance or contact a poison control center immediately if they accidentally ingest more than the recommended dose for pain relief. Pregnant or breastfeeding patients should consult a physician prior to use. Additionally, it is important to keep the medication out of reach of children.

Drug Information (PDF)

This file contains official product information for Gelato Anestesico Topical Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)