Gelato Topical Anesthetic

Description

SPL Code 34089-3 corresponds to a product identified as Gelato TA_Bubble Gum, which is presented in a dosage form of 12 grams. The product is characterized by its specific formulation and appearance, as indicated in the associated image file.

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

Healthcare professionals are advised to apply only the necessary amount of the medication to the oral mucosa to prevent or alleviate pain. It is important to note that this medication is contraindicated in children under the age of 2 years.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding without prior consultation with a healthcare professional.

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 inmediatamente 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 dolor, se debe buscar atención médica de inmediato o contactar a un Centro de Control de Envenenamiento.

Side Effects

El uso de este producto puede asociarse con una serie de reacciones adversas, algunas de las cuales son graves y requieren atención médica inmediata.

Una de las reacciones más serias es la metahemoglobinemia, una condición que puede reducir la cantidad de oxígeno transportado en la sangre. Esta afección puede presentarse incluso en pacientes que han utilizado el producto anteriormente. Se debe interrumpir el uso y buscar atención médica de inmediato si se observan síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, y fatiga o falta de energía.

Adicionalmente, se debe tener precaución en pacientes con antecedentes de alergias a anestésicos locales, como procaína, butacaína, benzocaína u otros anestésicos de "caína", ya que el uso del producto en estos individuos puede provocar reacciones alérgicas.

Se recomienda no utilizar el producto durante 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 desarrolla hinchazón, sarpullido o fiebre, se debe consultar a un médico de inmediato. Este producto no está indicado para la dentición ni para su uso en niños menores de 2 años.

Es importante evitar el contacto con los ojos; en caso de que esto ocurra, se debe enjuagar con abundante agua fresca. Además, no se debe exceder la dosis recomendada. Si se ingiere accidentalmente más de lo recomendado para el dolor, se debe buscar ayuda médica o comunicarse con un Centro de control de envenenamiento de inmediato.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Gelato Topical Anesthetic (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 recomienda a los profesionales de la salud tener en cuenta esta restricción al considerar el tratamiento en pacientes pediátricos.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients or those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 drug in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication 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

En caso de ingestión accidental de una dosis superior a la recomendada para el manejo del dolor, se debe buscar atención médica de inmediato. Es fundamental contactar a un Centro de Control de Envenenamiento para recibir orientación adecuada sobre la situación.

Los síntomas de sobredosis pueden variar, y es esencial que los profesionales de la salud estén atentos a cualquier manifestación clínica que pueda surgir. La intervención temprana 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 the occurrence of methemoglobinemia, a serious condition that requires prompt treatment as it reduces the amount of oxygen transported in the blood. This condition may arise even in individuals who have previously used the product without incident.

Users are advised to 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.

It is recommended that the product not be used for more than 7 days unless directed by a physician. If symptoms of oral pain do not improve within 7 days, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, medical consultation should be sought without delay. The product is not indicated for teething and should not be used in children under 2 years of age.

Patient Counseling

Advise patients to consult their healthcare provider if they are pregnant or breastfeeding before using the medication. It is important for them to understand the potential risks and benefits associated with its use during these periods.

Additionally, instruct patients to keep the medication out of the reach of children to prevent accidental ingestion or misuse. Emphasizing this precaution can help ensure the safety of young children in the household.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 69°F to 86°F (25°C to 30°C). It is essential to protect the product from freezing to maintain its efficacy and safety.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. It is important to keep the product out of reach of children. In the event of accidental ingestion of more than the recommended dose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)