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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
61509-103
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 strawberry 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.

When you use Mark 3, it works by numbing the affected area, helping to alleviate discomfort during healing. This product is made in the USA and comes in a convenient 1.12 oz. (32 g) tube, making it easy to apply when needed.

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. This makes it a safer option for those concerned about potential risks.

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 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, redness, swelling, rash, or fever, please consult your dentist or doctor right away.

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 a medication, it’s crucial to seek immediate medical help.

If an overdose occurs, contact your healthcare provider or local emergency services right away. Do not wait for symptoms to worsen. Remember, it’s always better to be safe and get professional assistance if you have any concerns about medication use.

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, make sure to consult your healthcare provider. They can help you understand the risks and explore safer alternatives for your needs during this important time.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions 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 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

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the 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 kidney health. They can provide guidance based on your individual situation.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 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 reliable for use.

Additional Information

You can use this product either 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 with a strawberry flavor.

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 during pregnancy?

The safety of Mark 3 during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

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.

Is there a risk of overdose with Mark 3?

If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

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 Vitamin E and Xylitol, designed for topical application. The product is presented in a strawberry flavor and is gluten-free. Each tube contains a net weight of 1.12 oz. (32 g). The National Drug Code (NDC) for this product is 61509-103-32. Mark 3 is distributed by Mark 3, located at 135 North Rt. 9W, Congers, NY 10920, and is manufactured in the USA.

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

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 12 years of age must be supervised during the use of this product to ensure safe and effective application. For children under 2 years of age, it is essential to consult a dentist or physician 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 medical attention. Additionally, any development of swelling, rash, or fever warrants immediate consultation with a healthcare provider.

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 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 are encouraged to seek medical attention if symptoms of a sore mouth 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, patients should promptly consult their dentist or doctor.

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 safety and proper application. For infants and children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

For 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

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 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 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 clinical status and consider the following management procedures:

  1. Symptom Assessment: Conduct a thorough evaluation of the patient to identify any symptoms indicative of overdosage.

  2. Supportive Care: Provide supportive care as necessary, which may include monitoring vital signs and ensuring the patient's safety.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific interventions and treatment protocols.

Prompt recognition and management of overdosage are crucial to mitigate potential complications and ensure patient safety.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 for identification. It should be stored at room temperature, within the range of 59 to 86°F (15 to 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.