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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
50227-2110
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 only and comes in a pleasant piña colada flavor gel, making it more palatable for patients during dental procedures.

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.

Dosage and Administration

When using this medication, it's important to apply it only to the inside of your mouth, as directed by your dentist. Make sure to follow their instructions carefully to ensure you get the best results. Always remember that this medication is specifically designed for oral mucosal (the lining of the mouth) use, so avoid using it in any other way. If you have any questions about how to use 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 your healthcare provider's instructions and use the medication only as directed.

Side Effects

It's important to be aware that this medication should not be used if you have known allergies to benzocaine or PABA (para-aminobenzoic acid) compounds, as this could lead to serious allergic reactions.

While using this medication, you may experience some side effects. Common reactions can include skin irritation or allergic responses, which may manifest as redness, itching, or swelling. If you notice any severe or unusual symptoms, it's crucial to seek medical attention promptly.

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 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, 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. Remember, timely intervention can make a significant difference.

Pregnancy Use

When considering medication during pregnancy, it's important to be aware that specific information about its use, safety concerns, dosage modifications, and special precautions is not provided. This means that if you are pregnant or planning to become pregnant, you should consult your healthcare provider for personalized advice. They can help you understand any potential risks and ensure that you make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be taking.

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 are no statements about the product being excreted in breast milk or any potential risks to your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

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 considering the use of benzocaine gel, it's important to note that there is no specific information available regarding its use in older adults. This means that there are no established guidelines for dosage adjustments, safety concerns, or special precautions for elderly patients.

If you are caring for an older adult who may need this topical anesthetic, it’s wise to consult with a healthcare professional to ensure it is appropriate for their individual health needs. Always prioritize safety and seek guidance tailored to their specific situation.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to perform regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions between this medication and other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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 works or its specific use, 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 come in?

It comes in a Piña Colada flavor gel.

What is the net content of PATTERSON DENTAL?

The net content is 1 fl oz (29.6 mL).

Is a prescription required for PATTERSON DENTAL?

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

Who should not use PATTERSON DENTAL?

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

What precautions should be taken when using PATTERSON DENTAL?

Keep PATTERSON DENTAL out of reach of children and do not use it on those with known allergies to benzocaine and PABA.

Can PATTERSON DENTAL be used during pregnancy?

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

Is there any information about PATTERSON DENTAL use in nursing mothers?

There are no specific warnings or recommendations regarding the use of PATTERSON DENTAL in nursing mothers.

What is the recommended storage condition for PATTERSON DENTAL?

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

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 product is a topical anesthetic formulated as a piña colada 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). The National Drug Code (NDC) for this product is 50227-2110-1, and the reorder number is 090-0019.

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 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 known hypersensitivity to benzocaine and para-aminobenzoic acid (PABA) compounds. The use of this product in such patients may lead to severe allergic reactions. Healthcare professionals should ensure that patients are screened for these allergies 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 drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

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 dosage adjustments, safety concerns, or special precautions outlined in the drug insert for the topical anesthetic benzocaine gel. As there is no available information regarding geriatric use, healthcare providers should exercise caution when administering this medication to patients aged 65 and older. It is advisable to monitor these patients closely for any adverse effects or unusual responses to treatment, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the potential benefits and risks when prescribing this medication to women of childbearing potential. It is recommended that healthcare providers discuss any concerns with their patients and consider alternative treatment options if necessary.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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 initiate supportive care, 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 use of the compound in these contexts.

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 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.