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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 3, 2014
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 3, 2014
Manufacturer
Cargus International, Inc.
Registration number
part356
NDC root
61509-109
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 formulated to be strawberry dye-free and gluten-free, making it suitable for a variety of users. Additionally, it contains Vitamin E and xylitol, which may offer added benefits for oral health.

You can use Mark 3 to help ease discomfort in your mouth, allowing for a more comfortable experience during healing or dental work.

Uses

If you're dealing with discomfort from canker sores or have recently undergone a minor dental procedure, this medication can help provide temporary relief from the pain. It’s designed specifically to ease the discomfort associated with these common oral issues, allowing you to feel more comfortable while you heal. Always consult with your healthcare provider for the best approach to managing your symptoms.

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, it's important to supervise their use of the product to ensure safety. For children under 2 years old, you should consult a dentist or doctor before using the medication. Always follow the guidance provided by your healthcare professional for the best results.

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, 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 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, 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, as timely intervention can make a significant difference in the outcome. Always follow the prescribed dosage to avoid the risk of an overdose.

Pregnancy Use

The safety of benzocaine during pregnancy has not been established, which means that it is not known if it is safe for you or your developing baby. Because of potential risks to the fetus, benzocaine is generally not recommended for use during pregnancy. If you are considering using benzocaine while pregnant, it is crucial to discuss this with your healthcare provider to weigh the potential benefits against the possible risks to your baby. Always prioritize your health and the health of your child when making decisions about medications during pregnancy.

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.

However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about using any product while breastfeeding. They can provide personalized advice based on your individual situation.

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

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 or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 for your specific condition. They can help you understand any necessary precautions or adjustments based on 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 should be used if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to be aware of potential interactions when considering any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "-caine" anesthetics, you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

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 both 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 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 supervising a child under 12, make sure they use it 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.

Who can use Mark 3?

Adults and children 12 years of age and older can use Mark 3. Children under 12 should be supervised, and those under 2 years of age should consult a dentist or doctor.

How should I use Mark 3?

Apply Mark 3 to the affected area up to 4 times daily or as directed by a dentist or doctor. Do not use for more than 7 days unless directed.

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.

Are there any allergies I should be aware of?

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

Is Mark 3 safe to use 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 are the storage instructions for Mark 3?

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

What should I do if I accidentally swallow more than the recommended dose?

If more than the recommended dose 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 for topical application. The product is strawberry dye-free and gluten-free, incorporating Vitamin E and Xylitol as active ingredients. It is packaged in a net weight of 1.12 oz. (32 g). The National Drug Code (NDC) for this product is 61509-109-32. 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. 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 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

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 due to the risk of severe allergic reactions.

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. In the event that an excessive amount is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center without delay to ensure appropriate management of potential toxicity.

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 symptoms may indicate a more serious condition that requires further evaluation and management.

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 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

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. Healthcare professionals should consider the use of benzocaine during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is essential to weigh the risks and benefits carefully when prescribing this medication to pregnant patients.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment. 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, neurological disturbances, gastrointestinal distress, and cardiovascular irregularities.

Management Procedures

Management of overdosage should be tailored to the individual patient and the specific circumstances of the overdose. In cases where the overdosage is significant, healthcare professionals may consider interventions such as activated charcoal administration, intravenous fluids, or other specific antidotes as indicated. Continuous monitoring and supportive care are essential to mitigate the effects of the overdose and ensure patient safety.

In all cases of suspected overdosage, it is crucial to consult relevant clinical guidelines and consider contacting a poison control center for additional support and recommendations.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and 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. 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 is essential to store the product at room temperature, maintaining a range of 59 - 86°F (15 - 30°C). Care should be taken to protect the product from freezing and excessive heat to ensure its integrity and efficacy.

Additional Clinical Information

The product is administered orally and dentally. For adults and children aged 12 years and older, it should be applied to the affected area up to four times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised during use, and for those under 2 years, consultation with a dentist or doctor is recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mark 3, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mark 3, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.