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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
50227-2113
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 relieve pain. This product contains 20% benzocaine, a common ingredient that works by blocking nerve signals in the body, providing temporary relief from discomfort.

Typically available in a raspberry-flavored gel, PATTERSON DENTAL is intended for professional use only, ensuring that it is applied safely and effectively in appropriate settings.

Uses

You may use this medication as a topical anesthetic, which means it can help 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. Always consult with your healthcare provider for personalized advice and information.

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 may be classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where you may feel a strong need to continue using a substance) can also occur, so it's crucial to use it only as directed and to follow all safety guidelines.

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 could trigger an allergic reaction.

While specific side effects are not detailed here, always consult with your healthcare provider if you experience any unusual symptoms or reactions after using the medication. Your safety and well-being are paramount.

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, do 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 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

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of benzocaine during pregnancy has not been established, meaning that its effects on you and your developing baby are not fully understood. Because of potential risks to the fetus, benzocaine is not recommended for use during pregnancy.

If you are pregnant, it is best to consult with your healthcare provider before using any medications, including benzocaine, to ensure the safety of both 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. 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 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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. 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 standard recommendations for taking this medication do not change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide 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 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 you understand how to manage your health while considering your liver condition.

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 feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

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 instructions provided with the product for safe use and disposal.

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 that contains 20% benzocaine and is intended for professional use only.

What are the indications for using PATTERSON DENTAL?

It is indicated as a topical anesthetic for oral mucosal use, specifically as directed by a dentist.

Are there any contraindications for PATTERSON DENTAL?

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

Can I use PATTERSON DENTAL during pregnancy?

Safety during pregnancy has not been established, and benzocaine is contraindicated due to potential risks to the fetus.

Is PATTERSON DENTAL safe for nursing mothers?

There are no specific warnings or recommendations regarding its use in nursing mothers.

What should I do if I have children?

Keep PATTERSON DENTAL out of reach of children, as it should not be used by them.

What is the storage requirement for PATTERSON DENTAL?

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

What is the flavor of PATTERSON DENTAL?

PATTERSON DENTAL comes in a raspberry flavor gel.

What is the net content of PATTERSON DENTAL?

The net contents of PATTERSON DENTAL are 1 fl oz (29.6 mL).

Is a prescription required for PATTERSON DENTAL?

Yes, 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 raspberry-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 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 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 medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should exercise caution when prescribing this medication 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.

Monitoring for signs of allergic reactions is recommended in patients with a history of sensitivities to these compounds. It is essential to educate patients and caregivers about the importance of recognizing early symptoms of an allergic response, such as rash, itching, or difficulty breathing, and to seek immediate medical attention if these occur.

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, no specific adverse reactions were reported beyond the contraindications. However, healthcare providers should remain vigilant for any signs of allergic reactions in patients with a history of sensitivity to these compounds. It is essential to monitor patients for any unexpected reactions following administration, particularly in those with a known allergy history.

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

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

Safety during pregnancy has not been established for this medication. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Healthcare professionals should exercise caution when prescribing this medication to pregnant patients, considering the lack of established safety and the potential for adverse fetal outcomes. Women of childbearing potential should be informed of these risks and advised to discuss any potential use of this medication with their healthcare provider.

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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 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 further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 compound in these areas.

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.