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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
64522-002
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 application, specifically to provide temporary relief from pain associated with minor dental procedures. It is designed to help ease discomfort during these procedures, making your experience more manageable. Always follow your dentist's directions when using this medication to ensure its effectiveness and safety.

Uses

This medication is intended for use in your mouth, specifically as directed by your dentist. It provides temporary relief from pain that may occur after minor dental procedures. If you're experiencing 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 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

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or risks of abuse or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

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. Additionally, do not exceed the recommended dosage, and if more than the intended amount is swallowed, 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 directed by a dentist or doctor. 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 promptly.

While using this product, avoid contact with your eyes. If it does come into contact with your eyes, flush them with water immediately. You should also stop using the product and consult a healthcare practitioner 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. If you accidentally swallow more than the recommended dosage, seek medical help or contact a Poison Control Center right away. Lastly, if you are pregnant or breastfeeding, it's best to consult a health 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, so don’t hesitate to reach out for assistance.

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 other "caine" anesthetics, you should avoid using this product. 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 both you and your child.

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 before starting the medication. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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. 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 a temperature between 59º - 86°F (15 - 30°C). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

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.

What should I do if I experience symptoms like weakness or difficulty breathing after using this product?

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

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 precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this drug.

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.

How should I store this drug?

Store the drug at temperatures between 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 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 associated image of the product is available, referenced as "LB.Vista Topical Wrap_R7.jpg," with a media type of image/jpeg.

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

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by minors. No other contraindications have been identified.

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 accidentally 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

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 recommended amount is accidentally ingested for pain relief, immediate medical assistance or contact with a Poison Control Center is necessary.

Additionally, it is important for pregnant or breastfeeding patients to consult a healthcare professional prior to using this medication.

Geriatric Use

There is no specific information available 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

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 maternal health. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare 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 mothers.

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 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 event of an overdosage, it is imperative that healthcare professionals adhere to the recommended dosage guidelines to prevent adverse effects. Should a patient accidentally ingest more than the prescribed amount intended for pain management, immediate medical assistance is required.

Healthcare providers should instruct patients or caregivers to contact a Poison Control Center without delay. This action is crucial for ensuring appropriate management and intervention.

Monitoring for potential symptoms of overdosage is essential, although specific symptoms are not detailed in the provided information. Therefore, vigilance in assessing the patient's condition following an overdosage incident is advised.

In summary, adherence to recommended dosages is critical, and any deviation necessitates prompt medical evaluation and intervention.

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 within two hours following administration.

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 should be stored at a temperature range of 59º to 86°F (15 to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

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.