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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 9, 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 9, 2012
Manufacturer
Patterson Dental Supply Inc
Registration number
part356
NDC root
50227-2111
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, which means it is applied directly to the skin or mucous membranes to numb the area and reduce pain. It contains 20% benzocaine, a common ingredient that works by blocking nerve signals in the body, providing temporary relief from discomfort. This product is specifically designed for professional use and comes in a strawberry-flavored gel form, making it more palatable for patients.

Uses

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

Additionally, there are no 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 it is considered safe in these aspects when used as directed.

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

You should avoid using this product if you have known allergies to benzocaine or PABA compounds, as it can cause serious allergic reactions. It's important to prioritize your safety and well-being by adhering to this guideline. If you have any concerns or questions about your allergies or the use of this product, please consult with a healthcare professional.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to use this medication safely, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone you know has 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 while using this medication, stop use immediately and call your doctor for guidance. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

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, 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.

Pregnancy Use

When considering the use of Topical Anesthetic Strawberry Benzocaine Gel during pregnancy, it's important to note that there is no available information regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical anesthetics. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby.

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 should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for 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 its use in children.

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 right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

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 new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

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, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

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 is used or its effects, be sure to consult your healthcare provider.

FAQ

What is PATTERSON DENTAL?

PATTERSON DENTAL is a topical anesthetic that contains 20% benzocaine and is intended for professional use only.

What flavor does PATTERSON DENTAL have?

PATTERSON DENTAL is available as a strawberry flavor gel.

What should I know about using PATTERSON DENTAL?

You should only use PATTERSON DENTAL for oral mucosal use as directed by a dentist.

Are there any contraindications for PATTERSON DENTAL?

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

What precautions should I take with PATTERSON DENTAL?

Keep PATTERSON DENTAL out of reach of children and do not use it if you have allergies to its ingredients.

Is there any information about the use of PATTERSON DENTAL during pregnancy?

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

How should I store PATTERSON DENTAL?

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

What is the net content of PATTERSON DENTAL?

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

Can I get PATTERSON DENTAL without a prescription?

No, 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 strawberry-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 teratogenic or nonteratogenic effects associated with its use.

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 potential for severe allergic reactions, administration in these patients may pose significant health risks.

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 known allergies to benzocaine and para-aminobenzoic acid (PABA) compounds. The use of this product in such patients may lead to severe allergic reactions, which can be life-threatening. Healthcare professionals should thoroughly assess patient history for any known sensitivities prior to administration.

Side Effects

Patients should be advised to keep this medication out of reach of children due to the potential for serious adverse reactions. It is crucial to ensure that the medication is stored safely to prevent accidental ingestion or exposure.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of safeguarding the medication cannot be overstated. Patients and caregivers should be educated on the risks associated with improper access to the medication by children.

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 the 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 factors when prescribing to pediatric populations to ensure safety and efficacy.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of Topical Anesthetic Strawberry 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 consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits before prescribing this medication during pregnancy.

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

There is no specific information 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 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 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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 or misuse. It is also important to inform patients that the medication should not be used by individuals with known allergies to benzocaine and PABA compounds, as this could lead to serious allergic reactions. Providers should encourage patients to discuss any history of allergies with them before starting the medication to ensure safe use.

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 information, 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.