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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
61509-106
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 grape flavor and is formulated with ingredients like Vitamin E and Xylitol, making it a gluten-free option for those in need of soothing relief.

When you apply Mark 3, it works by numbing the affected area, helping to alleviate discomfort during healing. It comes in a convenient 1.12 oz. (32 g) tube, making it easy to use whenever you need it.

Uses

You can use this medication for the temporary relief of pain caused by canker sores and minor dental procedures. It helps ease discomfort, allowing you to go about your daily activities with less interruption.

Rest assured, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

You can use this medication to help with your condition by applying it directly to the affected area. If you are an adult or a child aged 12 years and older, you can apply it up to four times a day, or as your dentist or doctor advises.

If you have a child 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 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 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, it's important not to use this product.

Be aware that if you experience a sore mouth that doesn't improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, you should contact your dentist or doctor. Additionally, seek medical attention if you develop swelling, a rash, or a fever.

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 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 do this by calling your local emergency number or going 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

When it comes to using benzocaine during pregnancy, there is currently no specific information available about its safety, recommended dosages, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using benzocaine. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking 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, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

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

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 for personalized advice. 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 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 determine the best approach based on your liver function and overall health.

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 noted, 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 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 are supervising a child under 12, make sure they use the product correctly. 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.

What are the key ingredients in Mark 3?

Mark 3 contains Vitamin E and Xylitol, and it is gluten-free.

How should I use Mark 3?

For adults and children 12 years and older, apply to the affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 should be supervised.

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 my 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 during pregnancy or while nursing?

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

What is the storage requirement for Mark 3?

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

How long can I use Mark 3?

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

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 grape 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 61509-106-32.

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

Use of this product is contraindicated for periods exceeding 7 days unless directed by a dentist or doctor. Additionally, 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, patients should seek prompt evaluation from a dentist or doctor.

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 to seek prompt evaluation from a dentist or doctor. Additionally, any development of swelling, rash, or fever warrants immediate medical attention.

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. Exceeding the recommended dosage can lead to adverse effects and complications.

In the event that an excessive amount of the product is ingested, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance. Prompt action is essential to mitigate potential risks associated with accidental overdose.

Side Effects

Patients should be aware of the potential for serious allergic reactions associated with the use of this product. Specifically, individuals with a 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 responses.

In clinical practice, if patients experience sore mouth symptoms that do not improve within 7 days, or if they notice any irritation, pain, or redness that persists or worsens, it is crucial to seek prompt medical attention from a dentist or doctor. Additionally, the development of swelling, rash, or fever should also prompt immediate consultation with a healthcare professional. These recommendations are essential to ensure the safety and well-being of patients using 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 safety and proper 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

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of benzocaine use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering benzocaine for pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for the use of benzocaine in pregnant individuals. Given the lack of data, it is advisable to weigh the potential benefits against any unknown risks when prescribing benzocaine to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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, 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 initiate appropriate supportive measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient’s safety.

Potential Symptoms

Symptoms of overdosage can manifest in various ways, and their severity may depend on the extent of the dosage exceeded. Common symptoms may include, but are not limited to, gastrointestinal disturbances, neurological changes, and cardiovascular irregularities. It is essential for healthcare professionals to remain alert to these signs and respond accordingly.

Management Procedures

Management of overdosage should be tailored to the individual patient and the specific circumstances of the incident. In cases where the overdosage is significant, consultation with a poison control center or toxicology expert may be warranted. Supportive care, including intravenous fluids and monitoring in a controlled environment, may be necessary to ensure patient stability and recovery.

In summary, exceeding the recommended dosage can lead to serious health implications, and prompt recognition and management are crucial in mitigating potential risks associated with overdosage.

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, a rash, or a fever during the use of this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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 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.

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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.