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Defend

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
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
January 24, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
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
January 24, 2022
Manufacturer
Mydent International
Registration number
part356
NDC root
70721-008
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

This medication is used for oral mucosal (the lining of the mouth) application, specifically as directed by your dentist. It provides temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable.

Uses

This medication is intended for use in your mouth, specifically as directed by your dentist. It provides temporary relief from pain that may occur after minor dental procedures. If you're experiencing discomfort following a dental visit, this product can help ease that pain, allowing you to feel more comfortable during your recovery. Always follow your dentist's instructions for the best results.

Dosage and Administration

When using this medication, apply only the amount needed directly to the oral mucosa (the moist tissue lining the mouth) to help prevent or relieve pain. It's important to use just the right amount to ensure effectiveness without wasting any of the product.

Please note that this medication is not suitable for children under 2 years of age, so if you have a young child, be sure to consult with a healthcare professional for appropriate alternatives. Always follow the instructions provided to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. Symptoms can include pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, and fatigue. If you or a child experiences any of these symptoms, stop using the product and seek immediate medical attention.

Additionally, if you have a history of allergies to local anesthetics like procaine or benzocaine, you should not use this product. It is also important to avoid using it for more than 7 days unless directed by a doctor, and it should not be used for teething or in children under 2 years old. Always avoid contact with your eyes, and if you accidentally swallow more than the recommended dose, seek medical help right away. If you are pregnant or breastfeeding, consult your physician before use.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. This can happen even if you've used it before. If you or a child experiences symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

Be cautious if you have a history of allergies to local anesthetics, such as procaine or benzocaine, as this product may not be safe for you. Do not use it for more than 7 days unless your doctor advises otherwise. If your sore mouth symptoms do not improve, or if you notice any irritation, pain, redness, swelling, rash, or fever, contact your physician right away. This product should not be used for teething or in children under 2 years of age. Always avoid contact with your eyes, and if it happens, rinse thoroughly with water. If you accidentally take more than the recommended dose, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, consult your doctor before using this product.

Overdose

Taking more medication than recommended can lead to serious health issues. If you accidentally swallow more than the prescribed amount for pain relief, it’s important to seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Always err on the side of caution—if you suspect an overdose, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe while breastfeeding. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Pediatric Use

It is important to note that this product should not be used in children under 2 years of age. If you are using this product for an older child, be vigilant for any serious side effects. You should stop using the product and seek immediate medical attention if your child experiences symptoms such as pale, gray, or blue-colored skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or unusual fatigue or lack of energy. Always prioritize your child's safety and well-being when considering any medication.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and responses to medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. Using this product could trigger an allergic reaction in you.

Additionally, be aware that this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. This can happen even if you've used the product safely in the past. Always discuss your medical history and any tests with your healthcare provider to ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures between 59°F and 86°F (15°C and 30°C). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication. Additionally, make sure to keep it out of reach of children to ensure their safety.

FAQ

What is the primary use of this drug?

This drug is for oral mucosal use only, as directed by your dentist, and provides temporary relief of pain due to minor dental procedures.

Are there any age restrictions for using this drug?

Do not use this drug in children under 2 years of age.

What should I do if I experience symptoms of methemoglobinemia?

If you or a child in your care develops symptoms such as pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop use and seek immediate medical attention.

Can I use this drug if I have allergies to local anesthetics?

No, do not use this drug if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine.

How long can I use this drug?

You should not use this drug for more than 7 days unless directed by a physician. If symptoms do not improve, consult your physician.

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

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

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask your physician before using this drug.

What precautions should I take when using this drug?

Avoid contact with eyes; if contact occurs, flush with water. Keep this drug out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Defend (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Defend.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SPL code 34089-3 corresponds to a topical formulation. The product is presented in a form suitable for application to the skin. Further details regarding its specific composition and characteristics are represented in the accompanying image, Topical_Defend.jpg.

Uses and Indications

This drug is indicated for oral mucosal use only, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The recommended dosage involves applying only the amount necessary to the oral mucosa to effectively prevent or relieve pain. It is important to note that this product is not indicated for use in children under 2 years of age. Healthcare professionals should ensure that the application is performed with care to achieve the desired therapeutic effect while minimizing the risk of adverse reactions.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This risk exists even in individuals who have previously used the product without issue. Healthcare professionals should advise patients to discontinue use and seek immediate medical attention if they or a child in their care exhibit any of the following symptoms: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, patients should be advised to consult their physician promptly. Additionally, this product is contraindicated for teething and should not be administered to children under 2 years of age.

While using this product, it is essential to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed with water immediately.

Patients must not exceed the recommended dosage. In cases where an overdose occurs, such as swallowing more than the recommended amount for pain relief, immediate medical assistance should be sought or the Poison Control Center contacted.

For individuals who are pregnant or breastfeeding, it is crucial to consult a physician prior to use to ensure safety for both the mother and child.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid using this product due to the risk of allergic reactions.

The product is not recommended for use beyond 7 days unless directed by a physician. Patients should seek medical advice if sore mouth symptoms do not improve within this timeframe, or if irritation, pain, or redness persists or worsens. Additionally, patients should consult a physician if swelling, rash, or fever develops. The product is contraindicated for teething and should not be used in children under 2 years of age.

While using this product, patients should take care to avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is crucial not to exceed the recommended dosage, and if more than the advised amount is accidentally ingested, medical help or contact with a Poison Control Center should be sought without delay.

Pregnant or breastfeeding patients are advised to consult a physician before using this product.

Drug Interactions

Patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product due to the risk of allergic reactions.

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in patients who have previously used the product without incident. Prompt treatment is essential if methemoglobinemia is suspected. Monitoring for signs and symptoms of this condition is advised, particularly in patients with risk factors or those receiving higher doses.

Packaging & NDC

Below are the non-prescription pack sizes of Defend (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Defend.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. In the event that a child develops any of the following symptoms while using this product, immediate medical attention should be sought: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue, or lack of energy.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when recommending this medication to lactating patients.

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 cases of overdosage, it is imperative that healthcare professionals adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the recommended dosage can lead to serious health complications.

If a patient accidentally ingests more than the prescribed amount intended for pain management, immediate medical assistance should be sought. It is crucial to contact a Poison Control Center or seek emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

Healthcare providers should remain vigilant and educate patients about the importance of adhering to prescribed dosages to avoid the dangers of overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a physician prior to use of this product. The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood, which necessitates prompt medical intervention. This adverse effect can occur even in individuals who have previously used the product without incident.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and may occur even in individuals who have previously used the product without incident.

Healthcare professionals and patients are advised to discontinue use and seek immediate medical attention if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children.

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 temperatures ranging from 59°F to 86°F (15°C to 30°C). Care should be taken to protect the product from freezing to maintain its integrity and efficacy. Proper storage conditions are crucial for ensuring the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. Additionally, it is important to keep the product out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Defend, 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 Defend, 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.