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Gelato Anestesico Topical Gel

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Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
January 25, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
January 25, 2022
Manufacturer
Mycone Dental Supply Co. , Inc DBA Keystone Industries and Deepak Products Inc
NDC root
68400-482
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is specifically designed for use in the oral mucosa, which is the lining of your mouth. It is typically recommended by your dentist and is used to provide temporary relief from pain associated with minor dental procedures. If you're experiencing discomfort after a dental visit, this drug can help ease that pain, allowing you to feel more comfortable during your recovery.

Uses

Este medicamento está diseñado exclusivamente para su uso en la mucosa oral, siguiendo las indicaciones de su dentista. Si has tenido un procedimiento dental menor y sientes molestias, este producto puede ayudarte a aliviar temporalmente el dolor. Recuerda siempre consultar a tu dentista para asegurarte de que estás utilizando el tratamiento adecuado para tu situación.

Dosage and Administration

Cuando necesite aliviar el dolor en la mucosa oral, aplique solo la cantidad necesaria del medicamento. Es importante no excederse en la dosis para asegurar un uso seguro y efectivo. Recuerde que este medicamento no está recomendado para niños menores de 2 años, así que asegúrese de seguir esta indicación para la seguridad de los más pequeños.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. Symptoms can appear even if you have used the product before. If you or a child in your care experiences pale, gray, or blue skin (cyanosis), headache, rapid heartbeat, difficulty breathing, dizziness, or fatigue, stop using the product and seek medical attention immediately.

Additionally, if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. It is also important to avoid using it for more than 7 days unless directed by a doctor. If your mouth pain does not improve in that time, or if you notice worsening irritation, swelling, rash, or fever, consult your doctor right away. This product should not be used for teething or in children under 2 years old.

Warnings and Precautions

El uso de este producto puede causar una condición grave llamada metahemoglobinemia, que reduce la cantidad de oxígeno en la sangre. Esto puede suceder incluso si lo ha usado antes. Si usted o un niño bajo su cuidado presenta síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o fatiga, detenga el uso de inmediato y busque atención médica.

Es importante no usar este producto si tiene antecedentes de alergias a anestésicos locales como procaína, butacaína o benzocaína. Además, no lo utilice por más de 7 días a menos que su médico lo indique. Si sus síntomas no mejoran en ese tiempo, o si nota irritación, dolor, enrojecimiento, hinchazón, sarpullido o fiebre, consulte a su médico. Evite el contacto con los ojos y, si esto ocurre, enjuague con abundante agua. No exceda la dosis recomendada y, si ingiere accidentalmente más de lo indicado, busque ayuda médica de inmediato. Si está embarazada o amamantando, consulte a su médico antes de usarlo.

Overdose

Es importante que no exceda la dosis recomendada de su medicamento. Si accidentalmente toma más de la cantidad indicada para el dolor, es crucial que busque ayuda médica de inmediato. Esto puede incluir llamar a un centro de control de envenenamiento, donde profesionales capacitados pueden guiarlo sobre los pasos a seguir.

Recuerde que tomar más medicamento del que se recomienda puede ser peligroso. Si nota síntomas inusuales o preocupantes, no dude en buscar atención médica. Su salud y seguridad son lo más importante.

Pregnancy Use

Si estás embarazada o amamantando, es muy importante que hables con tu médico antes de usar este medicamento. Ellos podrán ofrecerte la mejor orientación sobre su seguridad y cualquier posible riesgo para ti y tu bebé. Siempre es mejor estar bien informado y tomar decisiones seguras durante el embarazo y la lactancia.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your doctor before using this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding any medications you consider while nursing.

Pediatric Use

Es importante tener en cuenta que este medicamento no debe ser utilizado en niños menores de 2 años. Si usted está cuidando a un niño y nota síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos, aturdimiento, fatiga o falta de energía, debe detener el uso del medicamento de inmediato y buscar atención médica.

Además, asegúrese de mantener este medicamento fuera del alcance de los niños para evitar cualquier riesgo. Su seguridad y la de su hijo son lo más importante.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with kidney problems. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment plan is safe and effective for your condition. Always keep your doctor informed about your kidney health, as they can provide guidance tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use alongside other treatments or tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at a temperature below 30°C (86°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

This medication is administered through dental procedures. It's important to avoid contact with your eyes; if this happens, rinse them thoroughly with plenty of fresh water. If you accidentally take more than the recommended amount for pain relief, seek medical help or contact a poison control center right away.

If you are pregnant or breastfeeding, consult your doctor before using this medication. Additionally, keep it out of reach of children to ensure their safety.

FAQ

What is the primary use of this drug?

This drug is indicated for use solely in the oral mucosa for the temporary relief of pain due to minor dental procedures.

How should I apply this drug?

Apply only the necessary amount to the oral mucosa to prevent or relieve pain, as directed by your dentist.

Is this drug safe for children?

No, this drug should not be used in children under 2 years of age.

What should I do if I experience symptoms of metahemoglobinemia?

If you or a child under your care shows symptoms like pale, gray, or blue skin (cyanosis), headache, rapid heartbeat, difficulty breathing, dizziness, or fatigue, stop using the product and seek immediate medical attention.

Can I use this drug if I have allergies to local anesthetics?

No, do not use this drug if you have a history of allergies to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

How long can I use this drug?

Do not use this drug for more than 7 days unless directed by a doctor. If symptoms do not improve or worsen, consult your doctor immediately.

What precautions should I take while using this drug?

Avoid contact with your eyes; if contact occurs, rinse with plenty of fresh water. Keep out of reach of children.

What should I do if I accidentally take more than the recommended dose?

If you accidentally ingest more than the recommended dose, seek medical help or contact a Poison Control Center immediately.

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask your doctor before using this drug.

What is the recommended storage condition for this drug?

Store this drug at a temperature below 30°C and protect it from freezing.

Packaging Info

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

Packaging configurations for Gelato Anestesico Topical Gel.
Details

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)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are available.

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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 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

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 advertencias más significativas es la posibilidad de metahemoglobinemia, una condición que puede comprometer gravemente la capacidad de la sangre para transportar oxígeno. Esta reacción puede ocurrir incluso en pacientes que han utilizado el producto anteriormente sin incidentes. Se debe interrumpir el uso y buscar atención médica de inmediato si se presentan 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, tales como procaína, butacaína, benzocaína u otros anestésicos de tipo "caína", ya que el uso del producto en estos individuos puede provocar reacciones alérgicas severas.

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

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. 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.

Packaging configurations for Gelato Anestesico Topical Gel.
Details

Pediatric Use

El uso de este medicamento no está indicado en niños menores de 2 años. Se debe tener precaución debido al riesgo de metahemoglobinemia. Se recomienda interrumpir el uso y buscar atención médica inmediata si se presentan 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 en el paciente pediátrico. Además, es importante mantener el medicamento fuera del alcance de los niños.

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 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 if they are breastfeeding. 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

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 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 warranted based on clinical judgment.

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 use of the compound in these contexts.

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. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

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

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to avoid contact with the eyes; in the event of contact, patients should rinse thoroughly with fresh water. If a patient accidentally ingests more than the recommended dose for pain relief, they should seek medical assistance or contact a poison control center immediately. Additionally, patients who are pregnant or breastfeeding should consult a physician prior to use. It is also important to keep the product 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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Gelato Anestesico Topical Gel, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.