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Benzo Jel

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Active ingredient
Benzocaine 11.4 g/57 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray, Metered
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 11.4 g/57 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray, Metered
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 2016
Label revision date
February 15, 2024
Manufacturer
Henry Schein Inc.
Registration number
M006
NDC root
0404-0018
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 designed to provide temporary relief from occasional minor irritation and pain associated with canker sores and minor dental procedures. It is intended for professional use only, meaning it should be administered by a healthcare provider. If you are experiencing discomfort from these conditions, this drug may help alleviate your symptoms under the guidance of a professional.

Uses

You can use this medication for the temporary relief of minor irritation and pain caused by canker sores and minor dental procedures. It is designed to help ease discomfort during these situations, making it more manageable for you. However, please note that this product is intended for professional use only, so it's important to consult with a healthcare provider for appropriate guidance.

Dosage and Administration

When using Benzo-Jel Topical Anesthetic, you will apply a single metered spray, which delivers 50 mg of the medication. It's important to follow the instructions provided by your dentist carefully to ensure safe and effective use. This product is designed for topical application, meaning it is applied directly to the skin or mucous membranes in the area where you need relief. Always remember to use it only as directed to achieve the best results.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should avoid spraying the medication in your eyes, as this can cause irritation or discomfort.

Always follow the instructions provided and consult with your healthcare provider if you have any questions or concerns about using this medication safely. Your well-being is a priority, and understanding how to use your medication correctly is essential.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product.

Warnings and Precautions

Using this product comes with important safety considerations. It may cause a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child in your care experiences symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

You should also avoid this product if you have a known allergy to local anesthetics, such as procaine or benzocaine. It is flammable, so keep it away from fire or flames and avoid smoking while using it. Additionally, do not use this product for teething or in children under 2 years of age. If you suspect an overdose, contact a medical professional or Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using Benzocaine during pregnancy, there is currently no specific information available about its safety, recommended dosages, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, it's important to be aware that some substances can be passed into your breast milk. This means that if you use this product, there may be a risk to your infant. Therefore, it's essential to exercise caution when considering its use while nursing. Always consult with your healthcare provider to discuss any potential risks and ensure the safety of both you and your baby.

Pediatric Use

It's important to be cautious when using this medication in children. You should not give it to children under 2 years of age. Always keep the medication out of reach of children to prevent accidental ingestion.

If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance. Your child's safety is the top priority, so please follow these guidelines carefully.

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

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be aware that using this product may lead to a serious condition called methemoglobinemia. This condition can reduce the amount of oxygen in your blood, which requires prompt treatment. Because of this risk, you should always discuss any medications you are taking with your healthcare provider to ensure your safety.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's still crucial to keep your healthcare provider informed about all your medications and any tests you may undergo. This way, they can help you avoid potential complications and ensure the best care for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, avoiding any locations that exceed 120°F (49°C). This helps maintain its effectiveness and safety.

When it comes to disposal, please follow your local regulations to ensure that you are disposing of the product responsibly. By adhering to these guidelines, you can help ensure both your safety and the safety of the environment.

Additional Information

This product is administered through dental procedures. It's important to be aware of some serious health warnings associated with its use. It may cause a condition called methemoglobinemia, which reduces the amount of oxygen in your blood. If you or a child experiences symptoms like pale or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product and seek medical help immediately.

Additionally, if you have a history of allergies to local anesthetics (like procaine or benzocaine), you should not use this product. It is also flammable, so avoid using it near fire or while smoking. Do not use it for teething in children under 2 years old, and always keep it out of reach of children. In case of an overdose, contact a medical professional or Poison Control Center right away, and avoid spraying it in the eyes.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

Who should use this drug?

This drug is for Professional Use Only.

How is the drug administered?

A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

What should I do if I experience symptoms of methemoglobinemia?

Stop use and seek immediate medical attention if you or a child in your care develops symptoms like pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue.

Are there any allergies I should be aware of?

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

Is this product flammable?

Yes, this product is flammable. Do not use near fire or flame and avoid smoking during use.

Can this drug be used in children?

Do not use this product for teething or in children under 2 years of age.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

What precautions should nursing mothers take?

Nursing mothers should be cautious as this product may be excreted in breast milk, posing a risk to infants.

How should I store this drug?

Store at room temperature and do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Packaging Info

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

Packaging configurations for Benzo Jel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

Limitations of Use This drug is intended for professional use only.

Dosage and Administration

A single metered spray of Benzo-Jel Topical Anesthetic delivers 50 mg of the active ingredient. This product should be utilized strictly as directed by a dentist.

Healthcare professionals are advised to ensure that the administration technique is appropriate for the intended use, and to monitor the patient for any adverse reactions following application.

Contraindications

Use of this product is contraindicated in patients with a known hypersensitivity to any of its components. Additionally, the product should not be sprayed in the eyes due to the potential for irritation or injury.

Warnings and Precautions

Use of this product carries significant risks that healthcare professionals must be aware of to ensure patient safety.

Methemoglobinemia Warning This product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms can manifest even in patients who have previously used the product without issue. Immediate cessation of use and prompt medical attention are imperative if any of the following symptoms occur in the patient or a child under their care: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Allergy Alert This product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics. A thorough patient history should be taken to identify any such allergies prior to administration.

Flammability The product is flammable; therefore, it should not be used in proximity to fire or flame. Healthcare professionals should advise patients to avoid smoking during the use of this product to mitigate fire hazards.

Contraindications This product is not recommended for teething purposes and should not be administered to children under 2 years of age.

Overdose Management In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance. Prompt intervention is essential to manage potential complications effectively.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Additionally, there is an allergy alert associated with this product. It is contraindicated in individuals with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics. Patients with such allergies should avoid using this product to prevent potential allergic reactions.

Drug Interactions

The use of this product may lead to the development of methemoglobinemia, a serious condition characterized by the presence of methemoglobin in the blood, which impairs the oxygen-carrying capacity. Prompt treatment is essential to address this condition effectively.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for drug interactions is not indicated. However, healthcare professionals should remain vigilant for any signs of methemoglobinemia in patients receiving this product, particularly in those with predisposing factors.

Packaging & NDC

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

Packaging configurations for Benzo Jel.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information available 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.

Pregnancy

The safety of Benzocaine during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of Benzocaine in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to discuss the use of this medication with pregnant patients, considering the lack of available data.

Lactation

Nursing mothers should be aware of the potential for excretion of this product in breast milk. There is a risk to breastfed infants when nursing mothers use this product. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and may occur even in individuals who have previously used the product without incident.

Healthcare professionals are advised to instruct patients to discontinue use and seek immediate medical attention if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for guidance.

Additionally, it is important to inform patients to avoid spraying the medication in their eyes, as this could lead to irritation or other adverse effects. Clear communication of these points will help ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ensuring that the storage environment does not exceed 120°F (49°C).

Proper disposal of the product must be conducted in accordance with local regulations to ensure environmental safety and compliance.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients regarding the potential risk of methemoglobinemia, a serious condition that can reduce oxygen levels in the blood. Symptoms may include cyanosis (pale, gray, or blue skin), headache, rapid heart rate, shortness of breath, dizziness, and fatigue. Immediate medical attention is required if these symptoms occur, even if the product has been used previously without issue.

Patients with a history of allergy to local anesthetics, such as procaine, butacaine, or benzocaine, should avoid using this product. It is also flammable; therefore, it should not be used near fire or flame, and smoking should be avoided during use. The product is not recommended for teething in children under 2 years of age, and it should be kept out of reach of children. In the event of an overdose, medical assistance or contact with a Poison Control Center is advised, and care should be taken to avoid spraying the product in the eyes.

Drug Information (PDF)

This file contains official product information for Benzo Jel, 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 Benzo Jel, 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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Primary FDA sources:

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.