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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
61509-105
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 flavored with bubble gum and is gluten-free, making it a suitable option for many individuals. Additionally, it contains Vitamin E and xylitol, which may offer added benefits for oral health.

Uses

You can use this medication for the temporary relief of pain caused by canker sores and during minor dental procedures. It helps ease discomfort, allowing you to feel more comfortable while dealing with these common oral issues.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You can use this medication 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, 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 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 monitor your symptoms closely. If your sore mouth does not improve within 7 days, or if you experience worsening irritation, pain, or redness, you should contact your dentist or doctor. Additionally, seek medical attention if you notice any swelling, rash, or 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 that are not typical for you, and it’s important to be aware of these changes. If you suspect that you or someone else has taken too much of the medication, seek immediate medical help.

In case of an overdose, do not wait for symptoms to appear. Contact your healthcare provider or local emergency services right away. It’s crucial to act quickly to ensure safety and receive the appropriate care.

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 contraindicated, meaning it should not be used 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 always 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. This means that, based on the available information, it is considered safe for you to use without concerns about affecting your milk production or your baby. 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 keep a few guidelines in mind. If your child is under 12 years old, make sure they are supervised while using it to ensure their safety. For children under 2 years of age, it's best to consult with a dentist or doctor before use to get professional advice tailored to their needs. Always prioritize your child's health and safety by following these recommendations.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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

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 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 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.

Can I use Mark 3 if I am pregnant?

The safety of benzocaine 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.

What is the flavor of Mark 3?

Mark 3 has a bubble gum flavor.

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 bubble gum 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. The product is manufactured in the USA and is identified by the National Drug Code (NDC) 61509-105-32.

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. The recommended frequency of application is up to four times daily, or as directed by a dentist or doctor.

For children under 12 years of age, supervision is required 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, it is essential to consult a dentist or doctor promptly.

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 or contact a Poison Control Center without delay. Prompt action is essential to mitigate potential risks associated with overdose.

Side Effects

Patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "-caine" anesthetics, should not use this product due to the potential for serious allergic reactions.

In clinical practice, it is important to monitor patients for specific symptoms. If sore mouth symptoms do not improve within 7 days, or if patients experience persistent or worsening irritation, pain, or redness, they should seek prompt evaluation from a dentist or doctor. Additionally, the development of swelling, rash, or fever warrants immediate medical attention. These warnings are crucial for ensuring patient safety and effective management of adverse reactions.

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 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 lactating mothers. Additionally, there are no specific warnings or recommendations related to lactation in the provided information.

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 cases of overdosage, the administration of a dosage that exceeds the recommended levels may lead to adverse effects. Healthcare professionals should be vigilant in monitoring patients for potential symptoms associated with overdosage, which can 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 condition and consider the following management procedures:

  1. Assessment of Symptoms: Monitor the patient for any signs of toxicity or adverse reactions that may arise from the overdosage.

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

  3. Consultation with Poison Control: In cases of significant overdosage, consultation with a poison control center or a medical toxicologist is recommended for guidance on further management.

Prompt recognition and intervention are crucial in mitigating the potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. They should be counseled to monitor their symptoms closely; if sore mouth symptoms 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 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. Proper handling and storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

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.