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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
61509-102
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 mint flavor and is formulated with ingredients like Vitamin E and Xylitol, making it a soothing option for those experiencing oral discomfort.

You can use Mark 3 to help ease the pain while you recover from minor oral issues, allowing you to feel more comfortable during your daily activities. It is also gluten-free, catering to those with dietary restrictions.

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 to ease the irritation and make your recovery more comfortable. Remember, while it can alleviate pain, it’s important to follow any additional care instructions from your healthcare provider to ensure proper healing.

Dosage and Administration

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

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

What to Avoid

It's important to use this product responsibly. You should not use it for more than 7 days unless your dentist or doctor specifically tells you to do so. If your sore mouth symptoms do not improve within that time frame, or if you experience any irritation, pain, or redness that persists or worsens, you should contact your dentist or doctor right away. Additionally, if you notice any swelling, rash, or fever, seek medical attention promptly. 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 follow the recommended dosage and not use it for more than 7 days unless directed by a dentist or doctor. If your sore mouth symptoms do not improve within that time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please consult your dentist or doctor promptly.

Warnings and Precautions

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

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

Overdose

Taking more than the recommended dosage of a medication can lead to an overdose. Signs of an overdose may 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 follow the dosage instructions provided by your healthcare provider to avoid the risk of an overdose.

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. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its safety during lactation. Always consult with your healthcare provider if you have any questions or concerns about using any product while breastfeeding.

Pediatric Use

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

Geriatric Use

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 is safe and effective, especially if you have any concerns about your kidney health.

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 functional for your 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 you're using it for children under 12, make sure they are supervised during application. 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 with a mint 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.

How long can I use Mark 3?

Do not use this product for more than 7 days unless directed by a dentist or doctor. If symptoms do not improve, consult your healthcare provider.

Is Mark 3 safe to use during pregnancy?

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

What should I do if I accidentally swallow Mark 3?

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

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 mint 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. The National Drug Code (NDC) for this formulation is 61509-102-32.

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

Adults and children 12 years of age and older are instructed to apply the product to the affected area. The application may be performed 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 safety and proper application.

In the case of children under 2 years of age, it is essential to consult a dentist or doctor prior to use to determine the appropriateness of the product for this age group.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product 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, 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, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential risks associated with accidental overdose.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this product. 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 allergic reactions.

In clinical practice, it is advised that this product 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 this timeframe, or if irritation, pain, or redness persists or worsens, patients should seek prompt medical attention. Additionally, the development of swelling, rash, or fever warrants immediate consultation with a healthcare professional.

Patients are also cautioned against exceeding the recommended dosage, as this may lead to adverse effects. Adherence to these guidelines is essential to minimize the risk of complications.

Drug Interactions

The use of this product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "-caine" anesthetics. Patients with such a history should avoid this product to prevent potential 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

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

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

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on 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 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 seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. This may include monitoring vital signs, providing symptomatic treatment, and implementing any necessary interventions based on the severity of symptoms observed.

Potential Symptoms

Symptoms of overdosage can manifest in various ways, and their presentation may depend on the pharmacological properties of the drug. Common symptoms may include, but are not limited to, gastrointestinal disturbances, neurological effects, and cardiovascular irregularities. It is essential for healthcare professionals to remain alert to these signs and to document any findings thoroughly.

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 recent, activated charcoal may be considered to limit further absorption of the drug. Additionally, healthcare providers should be prepared to implement supportive measures, including intravenous fluids and medications to counteract specific symptoms or complications.

In all instances of suspected overdosage, consultation with a poison control center or a clinical toxicologist is recommended to ensure optimal management and care for the patient.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 59 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 of age, 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.