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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
64522-001
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 used for oral mucosal (the lining of the mouth) application, specifically as directed by your dentist. It provides temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable.

Uses

You can use this medication for oral mucosal (the lining of the mouth) purposes as directed by your dentist. It is specifically designed to provide temporary relief from pain that may occur due to minor dental procedures.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, you should apply just the right amount directly 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 mentioned in the provided information. This means that, based on the available details, there are no particular restrictions or warnings about taking or using this medication. 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, or if you experience irritation, pain, redness, swelling, rash, or fever, seek medical advice promptly.

While using this product, avoid contact with your eyes; if contact occurs, rinse with water. You should stop using it and consult a healthcare professional if you notice symptoms such as weakness, confusion, headache, difficulty breathing, or pale, grey, or blue skin, as these could indicate a rare condition called methemoglobinemia. Always follow the recommended dosage, and if you accidentally swallow more than intended, seek medical help immediately. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Warnings and Precautions

If you have a history of allergies to local anesthetics like benzocaine or other "caine" anesthetics, you should not use this product. It's important to limit use to no more than 7 days unless your dentist or doctor advises otherwise. If your sore mouth symptoms do not improve within that time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please consult your dentist or doctor right away.

While using this product, be careful to avoid contact with your eyes. If it does come into contact with your eyes, rinse them thoroughly with water. You should also stop using the product and seek medical advice if you notice symptoms such as weakness, confusion, headache, difficulty breathing, or if your skin turns pale, grey, or blue. These could be signs of a rare condition called methemoglobinemia, which may develop up to 2 hours after use. Additionally, do not exceed the recommended dosage, and if you accidentally swallow more than intended, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

Overdose

Taking more than the recommended dosage of medication can be dangerous. If you accidentally swallow more than what is prescribed for your pain, 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. Your health and safety are 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. If your child has a history of allergies to local anesthetics, such as benzocaine or other "caine" anesthetics, do not use this product. You should not use it for more than 7 days unless a dentist or doctor advises you to do so. If your child's sore mouth symptoms do not improve within that time, or if they experience worsening irritation, pain, redness, swelling, rash, or fever, contact their dentist or doctor right away.

Be alert for serious symptoms like weakness, confusion, headache, difficulty breathing, or changes in skin color (pale, grey, or blue), as these could indicate a rare condition called methemoglobinemia, which may develop up to 2 hours after use. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication.

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 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 situation. They can help you understand how your kidney health may affect your medications and what steps to take for your well-being.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 59º - 86°F (15 - 30°C). It's important to keep it protected from freezing, as extreme cold can damage the device.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that the product remains effective and safe for 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 for this drug.

What should I do if I experience symptoms like weakness or difficulty breathing?

Stop using the product and consult a healthcare practitioner immediately, as these may be signs of methemoglobinemia, a rare disorder.

How long can I use this drug?

Do not use this drug for more than 7 days unless directed by a dentist or doctor.

What should I do if my sore mouth symptoms do not improve?

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

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

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

What precautions should I take when using this drug?

Avoid contact with eyes, and if contact occurs, flush with water. Also, keep this drug out of reach of children.

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

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

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 drug is formulated as a topical wrap, designed for application to the skin. The effective date of the insert is March 29, 2018. The package label features a principal display panel that provides essential product information. An image of the product is available, referenced as "LB.Vista Topical Wrap_R7.jpg".

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.

Contraindications

There are no contraindications listed for this product. It is deemed safe for use across various patient populations, with no specific conditions or situations identified that would warrant avoidance.

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, the affected area should be flushed 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, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional before use to ensure safety.

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 this medication out of reach of children. The use of this product is contraindicated in individuals with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics.

The medication should 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, it is essential for patients to seek prompt evaluation from a dentist or healthcare provider.

Healthcare professionals should instruct caregivers to discontinue use and consult a healthcare practitioner if any of the following symptoms occur: weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin. These may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after application.

Additionally, pregnant or breastfeeding patients should consult a healthcare professional before using this medication.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 clinical trials for 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 regarding 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 are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation. 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

Postmarketing experience has identified that patients should discontinue use and consult a healthcare practitioner if symptoms such as weakness, confusion, headache, difficulty breathing, and/or pale, grey, or blue-colored skin occur. These symptoms may indicate the onset of methemoglobinemia, a rare disorder that can manifest up to 2 hours after administration.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

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 temperature range of 59º to 86ºF (15 to 30ºC). Care should be taken to protect the product from freezing to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

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.