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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)
Marketed in the U.S.
Since 1963
Label revision date
April 6, 2012
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
Marketed in the U.S.
Since 1963
Label revision date
April 6, 2012
Manufacturer
Patterson Dental Supply Inc
Registration number
part356
NDC root
50227-2115

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Drug Overview

Patterson Dental is a topical anesthetic gel that comes in a cherry flavor. It contains 20% benzocaine, which is a medication that helps numb the area where it is applied, providing relief from pain or discomfort. This product is intended for professional use only and is typically used in dental settings to help manage pain during procedures.

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.

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. Make sure to apply it exactly as recommended, and if you have any questions about how to use it, don’t hesitate to ask your dentist for clarification.

What to Avoid

If you have a known allergy to benzocaine or PABA (para-aminobenzoic acid) compounds, it is important that you do not use this medication. Using it in such cases could lead to serious allergic reactions. Always prioritize your safety by avoiding this product if you have these specific allergies.

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 avoid using this product, as it may cause serious allergic reactions.

While specific side effects are not detailed here, always monitor your body’s response after taking any medication and consult your healthcare provider if you experience any unusual symptoms. Your safety is a priority, so make sure to discuss any concerns with your doctor.

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 cause serious allergic reactions.

If you experience any unusual symptoms or reactions, stop using the medication 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, 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.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach any medication with caution during pregnancy. Since there are no special precautions mentioned regarding use during this time, you should consult with your healthcare provider before taking any medication. They can help you understand the potential risks and benefits based on your specific situation. Always prioritize open communication with your doctor to ensure the best outcomes for 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 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 its use in children.

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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential issues, ensuring that the treatment is safe and effective for the individual’s specific health needs.

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 available for how your treatment may need to be adjusted based on your kidney function.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that your treatment is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 the best care tailored to your 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 postmarketing experiences. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider for more information.

FAQ

What is PATTERSON DENTAL?

PATTERSON DENTAL is a topical anesthetic gel with a cherry 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?

Yes, do not use PATTERSON DENTAL on individuals with known allergies to benzocaine and PABA compounds.

What should I do if I have allergies to benzocaine?

If you have known allergies to benzocaine or PABA compounds, do not use PATTERSON DENTAL.

Is there any information about using PATTERSON DENTAL during pregnancy?

The provided text does not mention specific information regarding the use of PATTERSON DENTAL during pregnancy.

How should PATTERSON DENTAL be stored?

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).

Is a prescription required for PATTERSON DENTAL?

Yes, federal law prohibits dispensing PATTERSON DENTAL without a prescription.

What should I do if I accidentally ingest PATTERSON DENTAL?

Keep PATTERSON DENTAL out of reach of children and seek medical attention if ingested.

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 cherry-flavored gel containing 20% benzocaine. It is intended for professional use only and is packaged 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 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 guidelines 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 when administering this product to individuals with a known allergy to benzocaine or 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 prescribing or recommending this treatment.

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 should be considered, particularly in those with a history of hypersensitivity to the aforementioned compounds. It is essential for healthcare providers to evaluate the patient's allergy history prior to prescribing this medication to mitigate the risk of serious allergic reactions.

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. Healthcare professionals should ensure that caregivers are aware of these warnings to prevent potential adverse reactions in pediatric populations.

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

The use of this medication during pregnancy has not been specifically addressed in the available prescribing information. There are no documented safety concerns related to pregnancy, and no dosage modifications for pregnant individuals are recommended. Additionally, the prescribing information does not outline any special precautions for the use of this medication in pregnant patients. Healthcare professionals should consider the absence of specific data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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.

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 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 regarding allergies or potential side effects with their healthcare team.

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 is no additional information available regarding laboratory tests, abuse potential, 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.