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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 2014
Label revision date
March 23, 2021
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 2014
Label revision date
March 23, 2021
Manufacturer
Cargus International, Inc.
Registration number
part356
NDC root
61509-104
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 has a pleasant Pina Colada flavor and is formulated with Vitamin E and Xylitol, making it a soothing option for those experiencing oral discomfort.

As a gluten-free product, Mark 3 is suitable for individuals with gluten sensitivities, allowing you to manage your oral pain comfortably and effectively.

Uses

If you're dealing with discomfort from canker sores or have recently undergone a minor dental procedure, this medication can help provide temporary relief from the pain. It’s designed specifically to ease the discomfort associated with these common oral issues, allowing you to feel more comfortable while you heal. Remember, this relief is temporary, so it's important to follow up with your healthcare provider if your symptoms persist.

Dosage and Administration

You can apply this medication directly to the affected area, and it’s suitable for adults and children aged 12 years and older. You can use it up to four times a day, or follow the specific instructions given by your dentist or doctor.

If you have children under 12, make sure they are supervised while using the product. For children under 2 years old, it’s important to consult with a dentist or doctor before use to ensure safety and proper 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 directs 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. Your health and safety are paramount, so please follow these guidelines closely.

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 limit use to no 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, or redness, or if you develop swelling, a rash, or a fever, please consult your dentist or doctor promptly.

Warnings and Precautions

You should avoid using this product if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other "-caine" anesthetics. It's important not to use this product for more than 7 days unless your dentist or doctor advises you to do so. If your sore mouth symptoms do not improve within that time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please contact your dentist or doctor immediately.

Make sure to follow the recommended dosage carefully and do not exceed it. If you accidentally swallow more than the recommended amount for pain relief, seek medical help or contact a Poison Control Center right away. Your health and safety are important, so please take these precautions seriously.

Overdose

Taking more than the recommended dosage of a medication can lead to an overdose. Signs of an overdose may include unusual symptoms or worsening of your condition. It’s important to be aware of these signs so you can act quickly if they occur.

If you suspect an overdose, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always remember to keep medications out of reach and follow the prescribed dosage to avoid any risks associated with overdosing.

Pregnancy Use

There is currently no specific information available about the use of benzocaine during pregnancy, which means that safety concerns, dosage adjustments, or special precautions have not been clearly outlined. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using benzocaine or any medication. They can help you understand the potential risks and make informed decisions about your health and the health of your baby.

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. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

When using this product for children, it's important to supervise those under 12 years of age to ensure safe application. If your child is under 2 years old, you should consult a dentist or doctor before use. For children aged 12 and older, the product can be applied to the affected area up to four times a day, or as directed by a healthcare professional. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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.

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 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 functional for your 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 the user is under 12 years old, make sure they are supervised while using the product. For children under 2 years of age, 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.

What flavor does Mark 3 come in?

Mark 3 is flavored like Pina Colada.

Is Mark 3 gluten-free?

Yes, Mark 3 is gluten-free.

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 should consult a dentist or doctor.

How should I use Mark 3?

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?

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

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.

Can I use Mark 3 for more than 7 days?

Do not use Mark 3 for more than 7 days unless directed by a dentist or doctor.

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 immediately.

Is there any information about using Mark 3 during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Mark 3 during pregnancy or lactation.

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.

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 with a Pina Colada flavor. This product is gluten-free and contains Vitamin E and Xylitol as active ingredients. 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. Mark 3 is manufactured in the USA. The National Drug Code (NDC) for this product is 61509-104-32.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with canker sores and minor dental procedures. It is intended for use in patients experiencing discomfort from these specific oral conditions.

Dosage and Administration

For adults and children aged 12 years and older, the product should be applied to the affected area. The recommended frequency of application is up to four times daily, or as directed by a dentist or physician.

Children under the age of 12 should be supervised during the use of this product to ensure safe and effective application. For children under 2 years of age, it is advised to consult a dentist or physician 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 cases where symptoms of a sore mouth do not show improvement within this timeframe, or if there is a persistence or worsening of irritation, pain, or redness, it is imperative that the patient seeks prompt evaluation from their dentist or doctor. Additionally, any development of swelling, rash, or fever warrants immediate medical attention.

Healthcare professionals must ensure that patients do not exceed the recommended dosage of this product. In the event that a patient accidentally ingests more than the prescribed amount for pain relief, it is crucial to seek medical assistance or contact a Poison Control Center without delay to mitigate potential adverse effects.

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 specifically directed by a dentist or doctor. Patients should seek medical attention if sore mouth symptoms do not improve within this timeframe. Additionally, if any irritation, pain, or redness persists or worsens, or if symptoms such as swelling, rash, or fever develop, it is crucial for patients to consult their dentist or doctor promptly.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "-caine" anesthetics, should not use this product due to the risk of 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 application. For infants and children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

For adolescents and children aged 12 years and older, the product may be applied to the affected area up to four times daily, or as directed by a dentist or doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The prescribing information does not provide specific data regarding the use of benzocaine during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals should exercise caution when considering the use of benzocaine in pregnant patients. Given the lack of available information, the potential risks to fetal outcomes remain unclear. It is advisable for women of childbearing potential to discuss their treatment options with their healthcare provider to ensure informed decision-making regarding the use of benzocaine during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised 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.

It is important to inform patients that this product should not be used for more than 7 days unless specifically directed by a dentist or doctor.

Patients should also be counseled 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, if they notice any swelling, rash, or fever, they should seek medical attention without delay.

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 room temperature, maintaining a range of 59 - 86°F (15 - 30°C). Care should 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 experience.

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.