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Oral Pain Relief Gel

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 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 2022
Label revision date
March 25, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 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 2022
Label revision date
March 25, 2022
Manufacturer
Sled Distribution, LLC
Registration number
part356
NDC root
81417-121
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

Benzocaine 20% is an oral anesthetic used to provide temporary relief from minor pain and discomfort in the mouth. It is commonly used for issues such as toothaches, minor dental procedures, and irritations caused by dentures or orthodontic appliances.

When applied, Benzocaine works by numbing the affected area, helping to alleviate pain and discomfort. This makes it a helpful option for those experiencing minor oral issues, allowing you to manage discomfort effectively.

Uses

If you're experiencing minor pain or soreness in your mouth due to a toothache, minor dental procedures, or irritation from dentures or orthodontic appliances, this medication can provide temporary relief. It's designed to help ease discomfort so you can feel more comfortable during your daily activities.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this medication effectively, start by drying the affected area completely. Then, apply the medication directly onto the skin without diluting it. You can use it up to four times a day, but make sure not to apply it more often than every two hours unless your dentist or doctor advises otherwise.

This medication is meant for topical application, which means you will be putting it directly on your skin. Following these instructions will help ensure you get the best results from your treatment.

What to Avoid

It's important to be cautious when using this product. You should not use it if you experience any discomfort. If your sore mouth does not improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, stop using the product and consult your dentist or doctor. Additionally, seek medical advice if you develop swelling, a rash, fever, or any other signs of an allergic reaction. Your health and safety are paramount, so please take these precautions seriously.

Side Effects

If you experience a sore mouth that doesn't improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, it's important to stop using the product and consult your dentist or doctor. Additionally, seek medical attention if you develop swelling, a rash, fever, or any other signs of an allergic reaction. These symptoms may indicate a more serious issue that needs to be addressed.

Warnings and Precautions

This medication is intended for oral use only, so please ensure it is kept out of reach of children. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this medication and consult your doctor if you experience any discomfort. Additionally, if your sore mouth does not improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, it's important to reach out to your dentist or doctor. Be alert for signs of an allergic reaction, such as swelling, rash, or fever, and seek medical attention if these occur.

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 concerned about a possible overdose, 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 doubts.

Pregnancy Use

Currently, there is no information available about the use of this product during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before using this product to ensure your safety and the well-being of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children. For adults and children aged 2 years and older, you should dry the affected area before applying the medication directly without diluting it. You can use it up to four times a day, but make sure not to apply it more often than every two hours unless directed otherwise by a dentist or doctor. Always follow these guidelines to ensure safe and effective use 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, it’s important to consult with a healthcare provider before starting the medication. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always discuss any new medications, supplements, or changes in your health with your provider. They can help you understand how different treatments may work together and monitor your health effectively. Your safety and well-being are the top priority, so don't hesitate to ask questions or share concerns.

Storage and Handling

To ensure the best use of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you handle the product safely and responsibly.

Additional Information

No further information is available.

FAQ

What is Benzocaine 20% used for?

Benzocaine 20% is an oral anesthetic used for the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures, and irritations from dentures or orthodontic appliances.

How should I use Benzocaine 20%?

For adults and children aged 2 years and older, dry the affected area and apply the medication undiluted. You can use it up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Are there any contraindications for Benzocaine 20%?

No specific contraindications are mentioned for Benzocaine 20%.

What should I do if I experience discomfort while using Benzocaine 20%?

Stop using Benzocaine 20% and ask a dentist or doctor if you experience any discomfort.

What should I do if my sore mouth does not improve?

If your sore mouth does not improve in 7 days, or if irritation, pain, or redness persists or worsens, stop use and consult a dentist or doctor.

Is Benzocaine 20% safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of Benzocaine 20% during pregnancy or lactation.

What precautions should I take when using Benzocaine 20%?

Keep Benzocaine 20% out of reach of children, and if accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

What are the storage instructions for Benzocaine 20%?

Store Benzocaine 20% at room temperature and discard it after opening.

Packaging Info

Below are the non-prescription pack sizes of Oral Pain Relief Gel (benzocaine 20%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief Gel.
Details

Drug Information (PDF)

This file contains official product information for Oral Pain Relief Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Benzocaine is an oral anesthetic with a concentration of 20%. It is presented in a net weight of 0.75 grams.

Uses and Indications

This drug is indicated for the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures, and irritations from dentures or orthodontic appliances.

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication undiluted to the dry affected area. The medication may be used up to four times daily, ensuring that applications do not exceed every two hours, unless otherwise directed by a dentist or physician. It is essential to dry the affected area prior to application to ensure optimal effectiveness.

Contraindications

Use is contraindicated in patients experiencing discomfort. Discontinue use and consult a dentist or physician if the following conditions occur: sore mouth that does not improve within 7 days; persistent or worsening irritation, pain, or redness; or the development of swelling, rash, fever, or other signs of an allergic reaction.

Warnings and Precautions

For oral use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a doctor if they experience any discomfort. Additionally, patients should be instructed to stop use and seek advice from a dentist or physician if any of the following conditions occur: if a sore mouth does not improve within 7 days; if irritation, pain, or redness persists or worsens; or if any signs of swelling, rash, fever, or other allergic reactions develop.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for oral use only.

In clinical practice, it is important to monitor for specific adverse reactions. Patients are advised to stop use and consult a dentist or doctor if the sore mouth does not improve within 7 days. Additionally, if irritation, pain, or redness persists or worsens, medical advice should be sought. The development of swelling, rash, fever, or any other signs of an allergic reaction also necessitates immediate consultation with a healthcare professional.

These recommendations are based on clinical observations and are crucial for ensuring patient safety and effective management of any adverse reactions that may arise during treatment.

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 Oral Pain Relief Gel (benzocaine 20%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief Gel.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. For children aged 2 years and older, the affected area should be dried before applying the medication undiluted. The medication may be used up to four times daily, but not more frequently than every two hours, unless otherwise directed by a dentist or doctor.

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

There is no information available regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 fully evaluate the nonclinical toxicology profile.

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 reach of children to prevent accidental ingestion. In the event of accidental swallowing, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any discomfort. Additionally, they should be informed to stop using the product and seek advice from a dentist or doctor if any of the following occur: the sore mouth does not improve within 7 days, irritation, pain, or redness persists or worsens, or if they develop swelling, rash, fever, or any other signs of an allergic reaction.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Oral Pain Relief 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 Pain Relief 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

Last AI update:

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.