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Ms 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 2014
Label revision date
January 20, 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 2014
Label revision date
January 20, 2022
Manufacturer
M&S Dental Supply Co. , LLC
Registration number
part356
NDC root
69745-065
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 only and is typically prescribed by your dentist. It provides temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable. If you have any questions about its use or how it works, be sure to discuss them with your dental care provider.

Uses

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

Dosage and Administration

When using this medication, apply only the amount needed directly to the oral mucosa (the moist tissue lining the mouth) to help prevent or relieve pain. It's important to use just the right amount to ensure effectiveness without wasting any of the product.

If you have a child under 2 years of age, please do not use this medication for them, as it is not recommended for that age group. Always follow these guidelines to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular conditions or situations where you should avoid using it, nor are there any concerns about it being a controlled substance or leading to dependency.

However, it's always important to consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. Symptoms can include pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, and fatigue. If you or a child experiences any of these symptoms, stop using the product and seek immediate medical attention.

Additionally, if you have a history of allergies to local anesthetics like procaine or benzocaine, you should not use this product. It is also important to avoid using it for more than 7 days unless directed by a doctor, and it should not be used for teething or in children under 2 years old. Always avoid contact with your eyes, and if you accidentally swallow more than the recommended dose, seek medical help right away. If you are pregnant or breastfeeding, consult your physician before use.

Warnings and Precautions

Using this product comes with important warnings and precautions. One serious risk is methemoglobinemia, a condition that reduces the oxygen in your blood. This can happen even if you've used the product before. If you or a child experiences symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

You should also avoid using this product if you have a history of allergies to local anesthetics, such as procaine or benzocaine. Do not use it for more than 7 days unless your doctor advises otherwise. If your sore mouth symptoms do not improve, or if you notice any irritation, pain, redness, swelling, rash, or fever, contact your physician right away. This product is not suitable for teething or for children under 2 years of age. Always avoid contact with your eyes, and if it happens, rinse thoroughly with water. If you accidentally take more than the recommended dose, seek medical assistance or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, consult your doctor before using this product.

Overdose

It's important to always follow the recommended dosage for your medication. If you accidentally take more than the prescribed amount, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning after taking your medication, don’t hesitate to reach out for assistance. Remember, acting quickly can make a significant difference in your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe while breastfeeding. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Pediatric Use

It's important to be cautious when using this product for children. You should not use it in children under 2 years of age. If your child experiences any concerning symptoms such as pale, gray, or blue skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, lightheadedness, fatigue, or lack of energy while using this product, stop use immediately and seek medical attention.

Always keep this product out of reach of children to ensure their safety.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. Using this product could trigger an allergic reaction in those cases.

Additionally, be aware that this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. This can happen even if you've used the product before, so it's crucial to discuss any potential risks with your healthcare provider to ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures between 59°F and 86°F (15°C and 30°C). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity and safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

The medication is administered through a dental route, meaning it is used in dental procedures. If you are pregnant or breastfeeding, it's important to consult your physician before using this medication.

You should also be aware of certain symptoms that require immediate medical attention. If you or a child in your care experiences pale, gray, or blue-colored skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or unusual fatigue or lack of energy, stop using the medication and seek help right away.

FAQ

What is this drug used for?

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 age restrictions for using this drug?

Do not use this drug in children under 2 years of age.

What should I do if I experience symptoms of methemoglobinemia?

If you or a child in your care develops symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop use and seek immediate medical attention.

Can I use this drug if I have allergies to local anesthetics?

No, do not use this drug if you have a history of allergies to local anesthetics such as procaine, butacaine, or benzocaine.

How long can I use this drug?

You should not use this drug for more than 7 days unless directed by a physician. If symptoms do not improve, consult your physician.

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.

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask your physician before using this drug.

What should I avoid while using this product?

Avoid contact with your eyes. If contact occurs, flush with water.

How should I store this drug?

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

Packaging Info

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

Packaging configurations for Ms Topical Anesthetic.
Details

Drug Information (PDF)

This file contains official product information for Ms 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.

It is important to note that this medication is not recommended for use in children under 2 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This risk exists even in individuals who have previously used the product without issue. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop in the patient or a child in their care.

Allergy Alert This product is contraindicated in patients with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

Usage Restrictions The product should not be used for more than 7 days unless directed by a physician. If symptoms of sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, the patient should seek medical attention promptly. Additionally, this product is not indicated for teething and should not be administered to children under 2 years of age.

Precautions During Use Care should be taken to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed with water immediately.

Dosage Guidelines Patients must not exceed the recommended dosage. In cases where an excessive amount has been ingested, immediate medical assistance or contact with a Poison Control Center is advised.

Considerations for Pregnant or Breastfeeding Patients Consultation with a physician is recommended prior to use in pregnant or breastfeeding individuals to ensure safety.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. Additionally, it is advised that the product not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should seek medical advice promptly.

The product is contraindicated for use in children under 2 years of age and should not be used for teething. Patients are also cautioned to avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately.

Exceeding the recommended dosage can lead to serious consequences. If more than the recommended amount is accidentally ingested, patients should seek medical help or contact a Poison Control Center without delay. Pregnant or breastfeeding individuals are advised to consult a physician before using this product.

Drug Interactions

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

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in patients who have previously used the product without incident. Prompt treatment is essential if methemoglobinemia is suspected. Monitoring for signs and symptoms of this condition is advised, particularly in patients with risk factors or those receiving higher doses.

Packaging & NDC

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

Packaging configurations for Ms Topical Anesthetic.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. In the event that a child develops symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue, or lack of energy while using this product, immediate medical attention should be sought. Additionally, this product should be kept out of reach of children to ensure safety.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. It is important for healthcare professionals to assess the potential risks and benefits associated with the use of this medication in these populations. The safety of this medication during pregnancy and lactation has not been fully established, and caution is advised.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating patients.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 cases of overdosage, it is imperative that healthcare professionals adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the recommended dosage can lead to serious health complications.

If a patient accidentally ingests more than the prescribed amount intended for pain management, immediate medical assistance should be sought. It is crucial to contact a Poison Control Center or seek emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

Healthcare providers should remain vigilant and educate patients about the importance of adhering to prescribed dosages to avoid the dangers of overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a physician prior to use of this product. The use of this product may lead to methemoglobinemia, a serious condition that necessitates prompt treatment due to its potential to decrease the oxygen-carrying capacity of the blood.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified cases of methemoglobinemia associated with the use of benzocaine. Methemoglobinemia is a serious condition that reduces the amount of oxygen carried in the blood. These cases were reported voluntarily or through surveillance programs, highlighting the need for continued monitoring of the safety profile of benzocaine in the postmarketing setting.

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 necessity of proper storage to ensure the safety of young individuals.

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 temperatures ranging from 59°F to 86°F (15°C to 30°C). 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 physician prior to use. Additionally, patients should be instructed to discontinue use and seek immediate medical attention if they or a child in their care experience symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy.

Drug Information (PDF)

This file contains official product information for Ms 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 Ms 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.

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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.