Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Equate Oral Pain Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
August 18, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Oral
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 2007
Label revision date
August 18, 2020
Manufacturer
Sheffield Pharmaceuticals LLC
Registration number
part356
NDC root
11527-081
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 is a topical medication designed to provide temporary relief from minor irritation, pain, and soreness in the mouth. It is available in a maximum strength gel formulation containing 20% benzocaine, which works by numbing the affected area to alleviate discomfort.

You can use benzocaine to help ease occasional mouth pain, making it a helpful option for situations like sore gums or minor oral irritations. Always follow the instructions for use to ensure safe and effective relief.

Uses

You can use this medication for the temporary relief of occasional minor irritation, pain, and soreness in your mouth. It’s designed to help soothe discomfort, making it easier for you to eat and speak comfortably.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

Before using the Oral Pain Relief Gel, make sure the tube is intact and not cut before opening. To use the gel, carefully cut open the tip of the tube at the score mark. Then, take a small amount—about the size of a pea—using your fingertip or a cotton applicator, and apply it directly to the area that is causing you pain.

You can apply the gel up to four times a day, or as your dentist or doctor advises. This product is suitable for adults and children aged 2 years and older. If you are using it for a child under 12, make sure they are supervised during application. For children under 2 years old, it’s important to consult a doctor before use.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never take more than the directed amount, as exceeding the recommended dosage can lead to unwanted effects. Additionally, do not use this medication for more than 7 days unless your dentist or doctor specifically advises you to do so. Following these guidelines will help you avoid potential risks associated with misuse.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. It's important to follow the recommended dosage and not use it for more than 7 days unless directed by a dentist or doctor.

You should stop using the product and consult a doctor if you experience any swelling, rash, or fever. Additionally, if you notice that irritation, pain, or redness continues or gets worse, seek medical advice.

Warnings and Precautions

You should be aware of some important safety information before using this product. If you have ever had an allergic reaction to local anesthetics like procaine, butacaine, or benzocaine (often ending in "caine"), do not use this product. It's also crucial to follow the directions carefully: do not use more than recommended and avoid using it for more than 7 days unless your dentist or doctor advises otherwise.

If you notice any swelling, rash, or fever, or if irritation, pain, or redness continues or gets worse, stop using the product and contact your doctor. Additionally, keep this product out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is generally not recommended during pregnancy. If you are considering using this product, please consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if you do use benzocaine while pregnant, your healthcare provider may need to adjust the dosage. Always prioritize open communication with your healthcare professional to ensure the best care for you and 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. This means that, based on current knowledge, you can use this product without concern for its effects on your milk production or your baby’s health.

Pediatric Use

When using this product for children, it's important to keep a few guidelines in mind. If your child is under 12 years old, make sure they are supervised while using it. For children younger than 2 years, you should consult a doctor before use to ensure safety. For those aged 2 years and older, you can apply the product directly to the affected area as needed. Always prioritize your child's safety and well-being when using any medication.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

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

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 you understand how to manage your treatment effectively.

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 at a controlled room temperature between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help ensure your safety and the proper functioning of the device.

Additional Information

You can take this medication orally, applying it to the affected area up to four times a day, or as directed by your dentist or physician. Make sure to follow their instructions for the best results. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Benzocaine used for?

Benzocaine is used for the temporary relief of occasional minor irritation, pain, and sore mouth.

How should I apply Benzocaine?

Use your fingertip or a cotton applicator to apply a small pea-size amount of the gel to the affected area up to four times daily or as directed by a dentist or physician.

Who can use Benzocaine?

Adults and children 2 years of age and older can use Benzocaine. Children under 12 should be supervised, and those under 2 years should consult a doctor.

Are there any contraindications for using Benzocaine?

Yes, do not use Benzocaine if you have a history of allergy to local anesthetics such as procaine, butacaine, or other 'caine' anesthetics.

Can I use Benzocaine during pregnancy?

The safety of Benzocaine during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider for advice.

What should I do if I experience side effects?

Stop using Benzocaine and ask a doctor if you experience swelling, rash, fever, or if irritation, pain, or redness persists or worsens.

How should I store Benzocaine?

Store Benzocaine at a controlled room temperature between 59°-86°F (15°-30°C).

Is there a maximum duration for using Benzocaine?

Do not use Benzocaine for more than 7 days unless directed by a dentist or doctor.

Packaging Info

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

Packaging configurations for Equate Oral Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by the National Drug Code (NDC) 11527-081-28. It is formulated as a maximum strength gel for oral pain relief, containing 20% benzocaine as the active ingredient. The net weight of the product is 0.33 ounces (9.35 grams).

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation, pain, and soreness in the mouth.

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

Dosage and Administration

The tube should not be used if it is cut prior to opening. To prepare the product for use, the tip of the tube should be cut open at the score mark. A small pea-sized amount of Oral Pain Relief Gel should be applied to the affected area using a fingertip or a cotton applicator.

For adults and children aged 2 years and older, the gel may be applied to the affected area up to four times daily, or as directed by a dentist or physician. It is recommended that children under 12 years of age be supervised during the application of this product. For children under 2 years of age, consultation with a doctor is advised prior to use.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, do not use for more than 7 days unless directed by a dentist or doctor.

Warnings and Precautions

Use of 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.

It is imperative that the product is not used in excess of the recommended dosage. Additionally, the duration of use should not exceed 7 days unless specifically directed by a qualified healthcare professional, such as a dentist or physician.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following adverse reactions occur: development of swelling, rash, or fever; or if irritation, pain, or redness persists or worsens.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning includes an allergy alert; individuals with a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

It is crucial for patients to adhere to the recommended usage guidelines. The product should not be used more than directed or for a duration exceeding 7 days unless specifically instructed by a dentist or doctor.

Patients are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms: swelling, rash, or fever. Additionally, if irritation, pain, or redness persists or worsens, medical advice should be sought promptly.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Equate Oral Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equate Oral Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should be supervised during the use of this product to ensure safety and proper application. For infants and children under 2 years of age, it is advised to consult a doctor prior to use. For children aged 2 years and older, the product can be applied to the affected area as directed.

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

The safety of benzocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks with the use of benzocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage modifications may be necessary for pregnant individuals, and any use of this product should be considered only if clearly needed and after thorough discussion with a healthcare professional. Women of childbearing potential should be aware of these considerations when evaluating treatment options.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

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 an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless directed by a dentist or doctor. It is important for patients to be aware of potential adverse reactions; they should stop using the medication and consult a doctor if they experience swelling, rash, or fever. Additionally, if irritation, pain, or redness persists or worsens, patients should also seek medical advice.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally and should be applied to the affected area up to four times daily, or as directed by a dentist or physician. 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 Equate Oral Pain Relief, 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 Equate Oral Pain Relief, 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.