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Oral Gel

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
January 16, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
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 2010
Label revision date
January 16, 2010
Manufacturer
Budpak Inc.
Registration number
part356
NDC root
27293-012
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

You may be looking for a medication that provides temporary relief from pain associated with various oral conditions. This drug is commonly used for toothaches, canker sores, cold sores, fever blisters, and discomfort following minor dental procedures. It helps alleviate the pain you might experience in these situations, allowing you to feel more comfortable.

Uses

You can use this medication for the temporary relief of pain caused by various conditions. It is effective for toothaches, canker sores, cold sores, and fever blisters. Additionally, it can help ease discomfort following minor dental procedures.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus.

Dosage and Administration

To use this medication, start by cutting open the tip of the tube. You can then apply it directly to the affected area up to four times a day, or as your dentist or doctor advises. If you’re using this product for a child under 12 years old, make sure they are supervised during application to ensure safety.

For children under 2 years of age, it’s important to note that there is no recommended dosage unless specifically directed by a dentist or doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for young children.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid contact with your eyes, as this can lead to irritation or other issues. Additionally, make sure not to exceed the recommended dosage, as taking more than advised can be harmful.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

If you experience a sore mouth, it's important to monitor your symptoms closely. If your symptoms do not improve within 7 days, or if you develop swelling, a rash, or a fever, you should stop using the product and consult a doctor. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice.

Be cautious if you have a history of allergies to local anesthetics, such as procaine or butacaine, as this product may not be suitable for you. Remember, it’s recommended not to use this product for more than 7 days unless directed by a dentist or doctor.

Warnings and Precautions

It's important to use this medication carefully. Do not use it for more than 7 days unless your dentist or doctor specifically tells you to. If you have ever had an allergic reaction to local anesthetics like procaine or butacaine, you should avoid this medication.

You should stop using the medication and contact your doctor if your sore mouth symptoms do not improve after 7 days, or if you experience swelling, a rash, or fever. Additionally, if you notice any irritation, pain, or redness that gets worse, reach out to your healthcare provider.

If you accidentally swallow the medication, seek emergency medical help 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, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using Oral Gel Maximum Strength (benzocaine gel) during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, 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 product. They can help you understand any potential risks and guide you on the best options for your 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 talk to your healthcare professional before using this product. There is a possibility that it may be passed into your breast milk, which means it could affect your nursing infant. Because there haven't been specific studies on how this product impacts breastfeeding, it's best to exercise caution while using it. Your health and your baby's well-being are the top priorities, so make sure to seek guidance from a medical expert.

Pediatric Use

When using this product for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to four times a day, or as directed by a dentist or doctor. However, if your child is under 12 years old, make sure they are supervised while using the product to ensure safety.

For children younger than 2 years, there is no recommended dosage unless a dentist or doctor provides specific advice and supervision. Always consult with a healthcare professional if you have any questions or concerns about using this product for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware of potential interactions when taking medications. If you have a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), you should avoid using this medication. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

While there are no specific interactions with other drugs or laboratory tests mentioned, it's always a good practice to inform your healthcare provider about all the medications you are taking and any tests you may undergo. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. Always check the Lot Number and Expiration Date, which you can find on the box or the crimp of the tube, to ensure you are using a product that is still valid and safe.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, up to four times a day, or as directed by your dentist or doctor. Make sure to follow their instructions for the best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is this drug used for?

This drug is used for the temporary relief of pain associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

How should I use this drug?

For adults and children 2 years and older, apply to the affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 should be supervised during use.

Is there a recommended dosage for children under 2 years?

There is no recommended dosage for children under 2 years except under the advice and supervision of a dentist or doctor.

What should I avoid while using this drug?

Avoid contact with the eyes and do not exceed the recommended dosage. Do not use for more than 7 days unless directed by a dentist or doctor.

What should I do if my symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if swelling, rash, or fever develops, stop using the product and ask a doctor.

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

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

Is this drug safe to use during pregnancy?

There is no specific information regarding the use of this drug during pregnancy, so consult your healthcare provider for advice.

What about breastfeeding?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What should I do in case of accidental ingestion?

Get emergency medical help if the drug is swallowed.

How should I store this drug?

Store the drug at room temperature. Check the box or crimp of the tube for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Oral Gel.
Details

Drug Information (PDF)

This file contains official product information for Oral 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 provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area up to four times daily, or as directed by a dentist or doctor. Prior to application, the tip of the tube should be cut open. It is important that children under 12 years of age are supervised during the use of this product to ensure safe and effective application.

For children under 2 years of age, there is no recommended dosage unless specifically advised and supervised by a dentist or doctor.

Contraindications

Use is contraindicated in patients with a known hypersensitivity to any component of the formulation.

Avoid contact with the eyes, as this may lead to irritation or adverse effects.

Exceeding the recommended dosage is contraindicated due to the potential for increased risk of adverse reactions.

Warnings and Precautions

The use of this product is subject to specific warnings and precautions to ensure patient safety and efficacy.

Duration of Use This product should not be used for more than 7 days unless directed by a dentist or a doctor. Prolonged use without professional guidance may lead to adverse effects.

Allergic Reactions Patients with a history of allergy to local anesthetics, including but not limited to procaine, butacaine, or other "caine" anesthetics, should avoid using this product due to the risk of severe allergic reactions.

Monitoring Symptoms Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur:

  • Symptoms of a sore mouth do not improve within 7 days.

  • The development of swelling, rash, or fever.

  • Persistent or worsening irritation, pain, or redness.

Emergency Situations In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately. Prompt intervention is crucial to address potential complications associated with swallowing the product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to adhere to the recommended usage guidelines. The medication should not be used for more than 7 days unless directed by a dentist or a doctor. Patients with a history of allergy to local anesthetics, such as procaine, butacaine, or other "caine" anesthetics, should avoid using this product.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following symptoms occur: sore mouth symptoms that do not improve within 7 days, development of swelling, rash, or fever, or if irritation, pain, or redness persists or worsens. These reactions warrant immediate medical attention to ensure patient safety and appropriate management.

Drug Interactions

Patients with a history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics, should avoid the use of this medication due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Oral Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product, applying it to the affected area up to four times daily or as directed by a dentist or doctor. It is advised that children under 12 years of age be supervised during the use of the product to ensure proper application and safety. For infants and children under 2 years of age, there is no recommended dosage unless prescribed and supervised by a dentist or doctor.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of Oral Gel Maximum Strength (benzocaine gel) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential risks and benefits of using this product during pregnancy.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. Caution is advised when using this product while breastfeeding due to the lack of specific studies on its effects on nursing infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: sore mouth symptoms do not improve within 7 days; swelling, rash, or fever develops; or if irritation, pain, or redness persists or worsens.

While using this product, patients should be cautioned to avoid contact with the eyes and to adhere strictly to the recommended dosage, ensuring they do not exceed the prescribed amount.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. For reference, the Lot Number and Expiration Date can be found on the box or the crimp of the tube. Proper handling is essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with application to the affected area permitted up to four times daily or as directed by a dentist or doctor. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Oral 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 Oral 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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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.