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Topical Anesthetic

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This product has been discontinued

Active ingredient
Benzocaine 220 mg/1 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 1963
Label revision date
April 6, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 220 mg/1 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 1963
Label revision date
April 6, 2012
Manufacturer
Patterson Dental Supply Inc
Registration number
part356
NDC root
50227-2112
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

Patterson Dental is a topical anesthetic gel that comes in a mint flavor. It contains 20% benzocaine, which is a medication that helps numb the area where it is applied, providing relief from pain or discomfort during dental procedures. This product is intended for professional use only and is not available for dispensing without a prescription.

Uses

You can use this medication as a topical anesthetic, which means it helps numb a specific area of your skin. It's important to note that this product is intended for professional use only, so it should be applied by a qualified healthcare provider.

There are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects (which are effects that do not cause birth defects) associated with this medication. This means that, based on available information, it does not appear to pose risks in these areas.

Dosage and Administration

You should use this medication only in your mouth, as directed by your dentist. It's important to follow their instructions carefully to ensure you get the best results. If you have any questions about how to use it or when to apply it, don't hesitate to ask your dentist for clarification.

What to Avoid

It’s important to be aware of certain precautions when using this medication. You should not use it if you have known allergies to benzocaine or PABA compounds, as this could lead to serious reactions. Additionally, to ensure safety, always keep this medication out of reach of children.

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on a substance). Always follow the instructions provided and consult with your healthcare provider if you have any concerns.

Side Effects

It's important to be aware of potential side effects when using this medication. If you have a known allergy to benzocaine or PABA compounds, you should not use this product, as it could lead to serious allergic reactions.

Always consult with your healthcare provider if you experience any unusual symptoms or have concerns about your health while using this medication. Your safety is a priority, so understanding these warnings can help you make informed decisions.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have a known allergy to benzocaine or PABA compounds, you should not use this product, as it could trigger a serious allergic reaction.

If you experience any unusual symptoms or reactions, stop using the medication immediately and contact your doctor for further guidance. Always prioritize your safety and well-being when using any medication.

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 healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

Pregnancy Use

When considering the use of Topical Anesthetic Mint - benzocaine gel during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy are not well understood.

If you are pregnant or planning to become pregnant, it is advisable to consult with your healthcare provider before using this gel. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize your health and the health of your baby when making decisions about medication use during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child has a known allergy to benzocaine or PABA compounds, you should avoid using this product, as it could cause an allergic reaction. Always consult with a healthcare professional if you have any 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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking multiple medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations on how your treatment may need to be altered 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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to ensure the best outcomes for your health.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 59-86°F (15-30°C). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is PATTERSON DENTAL?

PATTERSON DENTAL is a topical anesthetic gel with a mint flavor, containing 20% benzocaine.

Who can use PATTERSON DENTAL?

PATTERSON DENTAL is for professional use only and should be used as directed by a dentist.

Are there any contraindications for using PATTERSON DENTAL?

Do not use PATTERSON DENTAL on individuals with known allergies to benzocaine and PABA compounds.

What should I do if I have children?

Keep PATTERSON DENTAL out of reach of children.

Is there any information about using PATTERSON DENTAL during pregnancy?

The insert does not provide specific information regarding the use of PATTERSON DENTAL during pregnancy.

What are the storage conditions for PATTERSON DENTAL?

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

Are there any known drug interactions with PATTERSON DENTAL?

No specific drug interactions are mentioned for PATTERSON DENTAL.

What is the net content of PATTERSON DENTAL?

PATTERSON DENTAL comes in a net content of 1 fl oz (29.6 mL).

What is the legal status of PATTERSON DENTAL?

Federal law prohibits dispensing PATTERSON DENTAL without a prescription.

Packaging Info

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

Packaging configurations for Topical Anesthetic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This topical anesthetic is formulated as a mint-flavored gel containing 20% benzocaine. It is intended for professional use only and is supplied in a net volume of 1 fluid ounce (29.6 mL).

Uses and Indications

This drug is indicated as a topical anesthetic for professional use only. There are no specific teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product is intended for oral mucosal use only, and it should be administered strictly as directed by a qualified dentist. Healthcare professionals are advised to ensure that patients understand the importance of adhering to the prescribed usage instructions to achieve optimal therapeutic outcomes.

Contraindications

Use is contraindicated in individuals with known allergies to benzocaine and PABA compounds due to the risk of severe allergic reactions. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Caution is advised in individuals with a known hypersensitivity to benzocaine or para-aminobenzoic acid (PABA) compounds. The use of this product in such patients may lead to severe allergic reactions, which could necessitate immediate medical intervention.

Healthcare professionals should ensure that patients are thoroughly screened for any history of allergies to these compounds prior to administration.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals with known allergies to benzocaine and PABA compounds.

In clinical trials and postmarketing experiences, adverse reactions have not been extensively documented; however, the potential for allergic reactions exists, particularly in those with a history of hypersensitivity to the aforementioned compounds. It is essential for healthcare providers to evaluate patients for any prior allergic responses before initiating treatment.

Patients experiencing any signs of an allergic reaction, such as rash, itching, or swelling, should seek immediate medical attention.

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 Topical Anesthetic (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topical Anesthetic.
Details

Pediatric Use

Pediatric patients should be cautioned that this product must be kept out of reach of children. It is contraindicated in individuals with known allergies to benzocaine and PABA compounds. Careful consideration should be given to these warnings to ensure the safety of pediatric populations.

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 Topical Anesthetic Mint - benzocaine gel during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the potential risks to fetal outcomes remain undetermined.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments or monitoring provided in the prescribing information. Therefore, healthcare professionals should exercise caution when considering treatment for patients with reduced kidney function, as the lack of data 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 this medication out of reach of children to prevent accidental ingestion or misuse. It is essential to inform patients that this product should not be used by individuals with known allergies to benzocaine or PABA compounds, as this may lead to serious allergic reactions. Providers should encourage patients to read the label carefully and discuss any concerns or questions regarding their allergies or the use of this medication.

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 59-86°F (15-30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the product is dental. 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 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 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.

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.