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Mark 3

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This product has been discontinued

Active ingredient
Benzocaine 6.4 g/32 g
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
March 3, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 6.4 g/32 g
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Oral
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 2012
Label revision date
March 3, 2014
Manufacturer
Cargus International, Inc.
Registration number
part356
NDC root
61509-108
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

Mark 3 is an oral anesthetic gel designed to provide temporary relief from pain associated with canker sores and minor dental procedures. This gel is formulated to be cherry dye-free and gluten-free, making it suitable for a variety of users. Additionally, it contains Vitamin E and xylitol, which may offer added benefits for oral health.

You can use Mark 3 to help ease discomfort in your mouth, allowing you to feel more comfortable during recovery from minor oral issues.

Uses

If you're dealing with discomfort from canker sores or have recently undergone a minor dental procedure, this medication can provide you with temporary relief from the pain. It's designed specifically to help ease the discomfort associated with these conditions, allowing you to feel more comfortable as you heal.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication, making it a safe option for those in need of pain relief in these situations.

Dosage and Administration

When using this medication, you should apply it directly to the affected area. If you are an adult or a child aged 12 years and older, you can use it up to four times a day, or as your dentist or doctor advises.

If you have a child under 12 years old, it's important to supervise their use of the product to ensure safety. For children under 2 years of age, you should consult a dentist or doctor before use to get specific guidance.

What to Avoid

It's important to use this product responsibly. You should not use it for more than 7 days unless your dentist or doctor specifically tells you to do so. If your sore mouth symptoms do not improve within that time frame, or if you experience any irritation, pain, or redness that persists or worsens, you should contact your dentist or doctor right away. Additionally, if you notice any swelling, rash, or fever, seek medical attention promptly. Taking these precautions will help ensure your safety and well-being.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other "-caine" anesthetics, you should not use this product. It's important to follow the recommended dosage and not use it for more than 7 days unless directed by a dentist or doctor. 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 promptly.

Warnings and Precautions

If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or any other "-caine" anesthetics, you should not use this product. It's important to follow the recommended dosage and not use it for more than 7 days unless your dentist or doctor advises otherwise. If your sore mouth symptoms do not improve within this time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please contact your dentist or doctor immediately.

In case you accidentally swallow more than the recommended amount for pain relief, seek medical help or contact a Poison Control Center right away. Always prioritize your health and safety by being aware of these precautions.

Overdose

Taking more than the recommended dosage of a medication can lead to an overdose. Signs of an overdose may vary depending on the specific medication, but they can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else has taken too much of a medication, it’s important to seek help immediately.

In the event of an overdose, contact your local emergency services or go to the nearest hospital right away. It’s crucial to provide medical professionals with as much information as possible, including the name of the medication and the amount taken. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is not recommended for use during pregnancy.

Before using any product containing benzocaine, you should consult your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's best to seek professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, the information provided does not mention any concerns about the product being excreted in breast milk, which means it is not expected to affect your milk supply or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

When using this product for children, it's important to supervise those under 12 years of age to ensure their safety. If your child is under 2 years old, you should consult a dentist or doctor before use to get specific guidance tailored to their needs. Always prioritize your child's health by seeking professional advice when necessary.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken. Always prioritize safety and open communication with your medical team when it comes to managing health in later years.

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 and what steps to take for your safety.

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.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to be aware of potential interactions when considering any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "-caine" anesthetics, you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests mentioned, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). It's important to keep it away from extreme temperatures, so make sure to protect it from both freezing and excessive heat.

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

Additional Information

You can use this product orally or dentally. For adults and children aged 12 and older, apply it to the affected area up to four times a day, or as directed by your dentist or doctor. If you're using it for a child under 12, make sure they are supervised. For children under 2 years old, it's important to consult a dentist or doctor before use.

FAQ

What is Mark 3?

Mark 3 is an oral anesthetic gel used for the temporary relief of pain associated with canker sores and minor dental procedures.

Who can use Mark 3?

Adults and children 12 years of age and older can use Mark 3. Children under 12 should be supervised, and those under 2 years of age should consult a dentist or doctor.

How often can I use Mark 3?

You can apply Mark 3 to the affected area up to 4 times daily or as directed by a dentist or doctor.

Are there any contraindications for using Mark 3?

Yes, do not use Mark 3 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other '-caine' anesthetics.

Can I use Mark 3 if I am pregnant?

The safety of Mark 3 during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider before use.

What should I do if symptoms do not improve?

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

How should I store Mark 3?

Store Mark 3 at room temperature between 59 - 86°F (15 - 30°C) and protect it from freezing and heat.

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

If more than the recommended dose is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Mark 3 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mark 3.
Details

Drug Information (PDF)

This file contains official product information for Mark 3, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mark 3 is an oral anesthetic gel formulated to provide localized pain relief. The product is free from cherry dye and gluten, making it suitable for individuals with specific dietary restrictions. It contains Vitamin E and Xylitol, which may contribute to its efficacy and palatability. The net weight of the gel is 1.12 oz. (32 g), and it is distributed by Mark 3, located at 135 North Rt. 9W, Congers, NY 10920. This product is manufactured in the USA. The National Drug Code (NDC) for Mark 3 is 61509-108-32.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with canker sores and minor dental procedures.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older should apply the product to the affected area up to four times daily, or as directed by a dentist or doctor.

For children under 12 years of age, supervision is recommended during the use of the product to ensure safe and effective application.

In the case of children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Contraindications

The product 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 7 days, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, prompt consultation with a dentist or doctor is advised.

Warnings and Precautions

Patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "-caine" anesthetics, should refrain from using this product. The potential for severe allergic reactions necessitates careful consideration of patient history prior to administration.

This product is not intended for use beyond a duration of 7 days unless specifically directed by a qualified healthcare professional, such as a dentist or physician. In the event that symptoms of a sore mouth do not show improvement within this timeframe, or if any irritation, pain, or redness persists or worsens, it is imperative that the patient seeks prompt evaluation from their dentist or doctor. Additionally, if any signs of swelling, rash, or fever develop, immediate medical attention is warranted.

Healthcare professionals must ensure that patients do not exceed the recommended dosage of this product. Overuse can lead to adverse effects and complicate the clinical picture.

In cases where more than the recommended amount has been accidentally ingested, it is crucial to seek medical assistance immediately or contact a Poison Control Center. Timely intervention is essential to mitigate potential risks associated with overdose.

Side Effects

Patients should be aware of the potential for serious allergic reactions associated with the use of this product. It is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "-caine" anesthetics.

In clinical practice, it is advised that this product not be used for more than 7 days unless directed by a dentist or doctor. Patients experiencing sore mouth symptoms that do not improve within this timeframe should seek medical advice. Additionally, if any irritation, pain, or redness persists or worsens, or if symptoms such as swelling, rash, or fever develop, patients are urged to consult their dentist or doctor promptly.

Exceeding the recommended dosage is strongly discouraged, as it may lead to adverse effects. Adherence to these guidelines is essential for the safe use of this product.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "-caine" anesthetics, should avoid the use of this product due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Mark 3 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mark 3.
Details

Pediatric Use

Pediatric patients under 12 years of age should be supervised during the use of this product to ensure safe and effective administration. For infants and children under 2 years of age, it is recommended to consult a dentist or doctor prior to use to assess appropriateness and 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, the primary concern is the administration of a dosage that exceeds the recommended levels. Healthcare professionals should be vigilant in monitoring patients for potential symptoms associated with overdosage, which may vary depending on the specific medication involved.

Recommended Actions

Upon suspicion of overdosage, it is imperative to take immediate action. Healthcare providers should assess the patient's clinical status and consider the following management procedures:

  1. Immediate Evaluation: Conduct a thorough assessment of the patient's vital signs and overall condition.

  2. Supportive Care: Provide supportive care as necessary, which may include intravenous fluids, monitoring of electrolytes, and symptomatic treatment.

  3. Consultation: Engage with a poison control center or a clinical toxicologist for guidance on specific antidotes or additional management strategies, if applicable.

Potential Symptoms

Symptoms of overdosage can vary widely and may include, but are not limited to, the following:

  • Altered mental status

  • Gastrointestinal disturbances

  • Cardiovascular irregularities

Healthcare professionals should remain alert to these symptoms and respond promptly to mitigate any adverse effects associated with the overdosage. Continuous monitoring and appropriate interventions are essential to ensure patient safety and recovery.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the recommended amount of this product for pain relief.

Patients should be informed that this product should not be used for more than 7 days unless specifically directed by a dentist or doctor. It is important for patients to monitor their symptoms closely. If symptoms of a sore mouth do not improve within 7 days, or if they experience persistent or worsening irritation, pain, or redness, they should promptly consult their dentist or doctor. Additionally, patients should be made aware that they should seek medical attention if they develop swelling, rash, or fever during the use of this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 59 - 86°F (15 - 30°C). Care must be taken to protect the product from freezing and excessive heat to ensure its integrity and efficacy.

Additional Clinical Information

The product is administered orally and dentally. For adults and children aged 12 years and older, it should be applied to the affected area up to four times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised during use, and for those under 2 years, consultation with a dentist or doctor is recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Mark 3, 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 Mark 3, 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.