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Gelato Topical Anesthetic

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Active ingredient
Benzocaine 2.4 g/12 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 2012
Label revision date
January 24, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 2.4 g/12 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 2012
Label revision date
January 24, 2022
Manufacturer
Mycone Dental Supply Co. , Inc DBA Keystone Industries and Deepak Products Inc.
NDC root
68400-429
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 used to provide temporary relief from pain associated with minor dental procedures. If you are experiencing discomfort after a dental visit, this medication may help ease your pain as directed by your dentist.

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 exceder la dosis recomendada para asegurar su efectividad y seguridad. Recuerde que este medicamento no está destinado para su uso en niños menores de 2 años, así que asegúrese de seguir esta recomendación para proteger su salud.

What to Avoid

If you are pregnant or breastfeeding, it’s important to consult with a doctor before using this medication. Your health and the health of your baby are paramount, and a healthcare professional can provide guidance tailored to your situation.

Additionally, keep this medication out of the reach of children. Ensuring that it is stored safely can help prevent accidental ingestion or misuse, which is crucial for their safety. Always prioritize responsible use to avoid any potential risks associated with this medication.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. Symptoms can occur 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 has usado antes. Si tú o un niño a tu cuidado presentan síntomas como piel pálida, gris o azul, dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o fatiga, detén el uso de inmediato y busca atención médica urgente.

Es importante que no uses este producto si tienes antecedentes de alergias a anestésicos locales como procaína, butacaína o benzocaína. Además, no lo utilices por más de 7 días a menos que tu médico lo indique. Si tus síntomas no mejoran en ese tiempo, o si experimentas irritación, dolor, enrojecimiento, hinchazón, sarpullido o fiebre, consulta a tu médico de inmediato. Este producto no debe ser utilizado para la dentición ni en niños menores de 2 años.

Cuando uses este producto, evita que entre en contacto con los ojos; si esto sucede, enjuaga con abundante agua fresca. No excedas la dosis recomendada, y si accidentalmente ingieres más de lo indicado, busca ayuda médica o contacta a un centro de control de envenenamiento de inmediato.

Overdose

If you accidentally take more of this medication than recommended for pain relief, it’s important to seek medical help right away. You can contact a healthcare professional or call a Poison Control Center for guidance.

Signs of an overdose may include unusual symptoms, so staying alert to how you feel is crucial. If you notice anything concerning, don’t hesitate to reach out for help immediately. Your safety is the top priority, so act quickly if you suspect an overdose.

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 este tiempo tan especial.

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

It's important to know that this medication should not be used in children under 2 years old. If you have younger children, make sure to keep this medication out of their reach to prevent any accidental ingestion. Always consult with your child's healthcare provider if you have any questions or concerns about using this medication for your child.

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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.

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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with liver problems in the provided information. This means that if you have liver conditions, you may not need to worry about special precautions related to this medication. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can give you personalized advice based on your situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 69°F and 86°F (25°C to 30°C). 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. Make sure to follow any additional safety guidelines provided to ensure safe and effective use.

Additional Information

The medication is administered through a dental route, meaning it is used in dental procedures. If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Additionally, keep it out of reach of children to ensure their safety.

FAQ

What is the drug used for?

The drug is indicated for the temporary relief of pain due to minor dental procedures.

How should I apply the drug?

Apply only the necessary amount to the oral mucosa to prevent or relieve pain, following your dentist's instructions.

Who should not use this drug?

Do not use this drug in children under 2 years old or if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine.

What should I do if I experience symptoms of methemoglobinemia?

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

Can I use this drug if I am pregnant or breastfeeding?

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

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 should I do if I accidentally take too much?

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

How should I store this drug?

Store the drug at 69° - 86°F (25 - 30°C) and protect it from freezing.

Are there any specific drug interactions?

No specific drug interactions are mentioned for this product.

Is there any information regarding use in elderly patients?

No relevant information regarding geriatric use or dosage adjustments is provided.

Packaging Info

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

Packaging configurations for Gelato Topical Anesthetic.
Details

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)

Description

Gelato Cherry is a topical formulation designed for external use only. It is presented in a gel form and contains active ingredients that provide a specific therapeutic effect. The formulation includes inactive ingredients such as water, glycerin, and various emulsifiers. Gelato Cherry is packaged in a 50 mL tube.

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 cantidad a aplicar, asegurándose de que sea la dosis adecuada para el paciente.

Contraindications

Use is contraindicated in pregnant or breastfeeding individuals unless directed by a healthcare professional. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

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 presentan los siguientes signos: 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 recomendada 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 advertencias más significativas es la posibilidad de metahemoglobinemia, una condición que puede comprometer la capacidad de la sangre para transportar oxígeno. Esta reacción puede ocurrir incluso en pacientes que han utilizado el producto anteriormente. 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 "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 su uso en la dentición ni en niños menores de 2 años.

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.

Packaging configurations for Gelato Topical Anesthetic.
Details

Pediatric Use

El uso de este medicamento no está indicado en niños menores de 2 años. Se debe tener especial cuidado para mantener el producto 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 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 physician 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, healthcare professionals should consider the potential risks and benefits when recommending this medication to lactating patients.

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 crucial que los profesionales de la salud estén atentos a cualquier manifestación clínica que pueda surgir. La intervención temprana es esencial para minimizar los riesgos asociados con la sobredosis y garantizar la seguridad del paciente.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

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.

Additionally, 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 immediately. 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 optimal preservation of its integrity. It should be stored at a temperature range of 69°F to 86°F (25°C to 30°C). Care must be taken to protect the product from freezing, as exposure to freezing temperatures may compromise its quality. Proper handling and storage conditions are essential to maintain the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. Additionally, it is important to keep the product out of the reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)

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 Topical Anesthetic, 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.

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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.