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Vistacaine Topical Anesthetic

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This product has been discontinued

Active ingredient
Benzocaine 200 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 2018
Label revision date
January 24, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 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 2018
Label revision date
January 24, 2022
Manufacturer
Inter-Med, INC.
Registration number
part356
NDC root
64522-003
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

This medication is designed for oral mucosal use, specifically to provide temporary relief from pain associated with minor dental procedures. It is typically used as directed by your dentist to help manage discomfort during and after dental work.

Uses

This medication is intended for use in your mouth, specifically as directed by your dentist. It is designed to provide temporary relief from pain that may occur after minor dental procedures. If you experience discomfort following a dental visit, this product can help ease that pain, allowing you to feel more comfortable during your recovery. Always follow your dentist's instructions for the best results.

Dosage and Administration

When using this medication, you should apply just the right amount to the inside of your mouth (oral mucosa) to help prevent or relieve any pain you may be experiencing. It's important to use only the necessary amount to ensure effective relief. Make sure to follow any specific instructions provided by your healthcare professional for the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You should be aware of some important safety information when using this product. If you have a history of allergies to local anesthetics like benzocaine or other "caine" anesthetics, you should not use it. It's also important not to use this product for more than 7 days unless directed by a dentist or doctor. If your sore mouth symptoms do not improve in that time, or if you experience irritation, pain, redness, swelling, rash, or fever, you should consult your healthcare provider.

While using this product, avoid contact with your eyes; if contact occurs, rinse with water. Be alert for serious symptoms such as weakness, confusion, headache, difficulty breathing, or changes in skin color (like pale, grey, or blue), as these could indicate a rare condition called methemoglobinemia, which may develop up to 2 hours after use. If you accidentally swallow more than the recommended dose, seek medical help immediately. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this product. First, if you have a history of allergies to local anesthetics like benzocaine or other "caine" anesthetics, you should not use this product. Additionally, do not use it for more than 7 days unless your dentist or doctor advises you to do so. If your sore mouth symptoms do not improve in that time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please consult your dentist or doctor right away.

When using this product, be careful to avoid contact with your eyes; if it happens, rinse your eyes with water immediately. You should also stop using the product and seek medical help if you notice symptoms like weakness, confusion, headache, difficulty breathing, or skin that appears pale, grey, or blue, as these could indicate a rare condition called methemoglobinemia. If you accidentally swallow more than the recommended dose, contact a Poison Control Center or seek medical assistance right away. Lastly, if you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product.

Overdose

Taking more medication than recommended can be dangerous. If you accidentally swallow more than the prescribed amount for pain relief, it’s important to seek medical help right away or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual symptoms that you should not ignore. Always err on the side of caution and get help if you suspect an overdose has occurred. Remember, your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child has a history of allergies to local anesthetics, such as benzocaine or any other "caine" anesthetics, do not use this medication. Always follow the recommended dosage carefully; if your child accidentally swallows more than the prescribed amount, seek medical help or contact a Poison Control Center right away.

If you are pregnant or breastfeeding, it's best to consult with a healthcare professional before using this medication. Taking these precautions can help ensure the safety and well-being of 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 wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory).

Always ensure that your doctor is aware of your age and any other health conditions you may have, as this can help them make the best decisions regarding your treatment. Regular check-ins can also help monitor how well the medication is working and if any adjustments are needed.

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 for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney health.

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.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and 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 get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures between 59º - 86°F (15 - 30°C). It's important to protect it from freezing, as extreme cold can damage the device.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You should be aware that this medication is administered through dental procedures. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is the primary use of this drug?

This drug is for oral mucosal use only, as directed by your dentist, and provides temporary relief of pain due to minor dental procedures.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but do not use it if you have a history of allergies to local anesthetics like benzocaine.

How should I apply this drug?

Apply only the amount needed to the oral mucosa to prevent or relieve pain.

What should I do if my symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, consult your dentist or doctor.

What are the warnings associated with this drug?

Avoid contact with eyes, and if symptoms like weakness, confusion, or difficulty breathing occur, stop use and consult a healthcare practitioner.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if I accidentally swallow more than the recommended dosage?

If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

What is the storage requirement for this drug?

Store the drug at 59º - 86°F (15 - 30°C) and protect it from freezing.

Packaging Info

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

Packaging configurations for Vistacaine Topical Anesthetic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for oral mucosal use only, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Healthcare professionals are advised to apply the necessary amount of the medication directly to the oral mucosa to effectively prevent or relieve pain. The specific dosage should be tailored to the individual patient's needs, ensuring that only the required amount is utilized for optimal results. Care should be taken to ensure proper application techniques to maximize efficacy and minimize discomfort.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should not use this product due to the risk of severe allergic reactions.

This product should not be used for more than 7 days unless specifically directed by a dentist or physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, it is imperative to seek prompt consultation with a dentist or healthcare provider. Additionally, if any signs of swelling, rash, or fever develop, immediate medical attention is warranted.

While using this product, it is crucial to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed thoroughly with water.

Users must discontinue use and consult a healthcare practitioner if they experience symptoms such as weakness, confusion, headache, difficulty breathing, or changes in skin color (pale, grey, or blue). These symptoms may indicate methemoglobinemia, a rare but serious condition that can manifest up to 2 hours after application.

It is essential not to exceed the recommended dosage. In cases where more than the advised amount is ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or breastfeeding, it is advisable to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Allergic reactions may occur, particularly in individuals with a history of allergies to local anesthetics, such as benzocaine or other "caine" anesthetics. It is advised that this product not be used for more than 7 days unless directed by a dentist or doctor. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, patients should seek prompt consultation with their healthcare provider. Additionally, if any swelling, rash, or fever develops, medical advice should be sought immediately.

During use, patients must avoid contact with the eyes. In the event of accidental contact, it is recommended to flush the eyes with water.

Patients should discontinue use and consult a healthcare practitioner if they experience symptoms such as weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin. These symptoms may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after application.

It is crucial not to exceed the recommended dosage. In cases where more than the intended amount is accidentally ingested, patients should seek medical assistance or contact a Poison Control Center without delay.

For pregnant or breastfeeding individuals, it is advisable to consult a healthcare professional before using this product.

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

Packaging configurations for Vistacaine Topical Anesthetic.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. The use of this medication is contraindicated in patients with a history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics.

Healthcare professionals should ensure that the recommended dosage is not exceeded. In the event that more than the prescribed amount is accidentally ingested, immediate medical assistance or contact with a Poison Control Center is necessary.

For pregnant or breastfeeding patients, consultation with a healthcare professional is recommended prior to use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 are no 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 event of an overdosage, it is critical to adhere to the recommended dosage guidelines. Exceeding the prescribed amount can lead to serious health risks. Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is required.

Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Reports of methemoglobinemia, a rare disorder, have been noted in the postmarketing experience. This condition may manifest up to 2 hours after use. Symptoms associated with methemoglobinemia can include weakness, confusion, headache, difficulty breathing, and/or pale, grey, or blue-colored skin. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 59º - 86°F (15 - 30°C). Care should be taken to protect the product from freezing to ensure its integrity and efficacy. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

The route of administration for the medication is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Vistacaine 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 Vistacaine 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

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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.