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Dentek Instant Pain Relief

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 mL
Other brand names
Dosage form
Liquid
Routes
  • Dental
  • Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
October 18, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 mL
Other brand names
Dosage form
Liquid
Routes
  • Dental
  • Topical
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 2015
Label revision date
October 18, 2021
Manufacturer
DenTek Oral Care, Inc.
Registration number
part356
NDC root
60630-077
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

DenTek™ is an oral anesthetic that provides instant pain relief, specifically designed to help you manage discomfort from toothaches, canker sores, cold sores, and sore gums. It contains 20% benzocaine, which works by numbing the affected area to alleviate pain temporarily.

This product comes in a convenient bottle with applicators, making it easy to apply directly where you need relief. Whether you're dealing with a sudden toothache or irritation from sores, DenTek™ can help you feel more comfortable.

Uses

If you're experiencing pain from toothaches, canker sores, cold sores, or sore gums, this medication can provide you with temporary relief. It's designed to help ease the discomfort associated with these common oral issues, allowing you to feel more comfortable in your daily activities.

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 product, you should apply a small amount directly to the affected area. If you are an adult or a child aged 2 years and older, you can use it up to four times a day, or follow the specific instructions given by your dentist or doctor.

If you are applying this product for a child between the ages of 2 and 12, it's important that they are supervised during use to ensure safety. However, if the child is under 2 years old, you should not use this product at all. Always make sure to follow the recommended guidelines for the best results.

What to Avoid

It's important to be cautious when considering this medication. You should not use it for teething, and it is not safe for children under 2 years of age. Following these guidelines helps ensure the safety and well-being of your child. Always consult with a healthcare professional if you have any questions or concerns about its use.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of 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 (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, if you have a history of allergies to local anesthetics (like procaine or benzocaine), you should avoid this product. You should also consult a dentist or doctor if you notice swelling, rash, or fever, if irritation or pain continues or worsens, or if your symptoms do not improve within 7 days.

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.

If you have a known allergy to local anesthetics such as procaine, butacaine, or benzocaine, do not use this product. Additionally, you should stop using it and consult a dentist or doctor if you develop swelling, rash, or fever, if irritation or pain persists or worsens, or if your symptoms do not improve within 7 days. In case of an overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. 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 notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that this product has not been evaluated for safety during pregnancy. Due to potential risks to the fetus, it is generally not recommended for use while you are pregnant. There are concerns about possible risks associated with benzocaine, a key ingredient in the product.

Before using this product, you should consult your healthcare provider to discuss any potential risks and to ensure it is safe for you and your baby. There are no specific dosage modifications provided for pregnant individuals, so professional guidance is essential.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

It's important to be cautious when using this product for children. You should not use it for teething, and it is not safe for children under 2 years of age. For children aged 2 years and older, you can apply a small amount to the affected area up to four times a day, but it's best to follow the advice of a dentist or doctor.

If your child is between 2 and 12 years old, make sure they are supervised while using this product to ensure their safety. Always prioritize their well-being and consult a healthcare professional if you have any concerns.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 health situation. They can help determine the best course of action based on your kidney function and overall 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 using this product. If you have a history of allergies to local anesthetics, such as procaine, butacaine, or benzocaine (often ending in “caine”), you should avoid using this product. Additionally, this product may lead to a serious condition called methemoglobinemia, which affects how oxygen is carried in your blood.

Always discuss any medications or tests with your healthcare provider to ensure your safety and to understand how they may interact with your current health conditions or treatments. Your provider can help you navigate these concerns effectively.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25⁰C (68-77⁰F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is DenTek™ used for?

DenTek™ is used for the temporary relief of pain due to toothaches, canker sores, cold sores, and sore gums.

What is the active ingredient in DenTek™?

The active ingredient in DenTek™ is benzocaine, which is an oral anesthetic at a concentration of 20%.

Who can use DenTek™?

DenTek™ can be used by adults and children 2 years and older. Children between 2 and 12 years should be supervised during use.

Are there any age restrictions for using DenTek™?

Do not use DenTek™ in children under 2 years of age.

What should I do if I experience side effects?

Stop using DenTek™ and seek medical attention if you experience symptoms like pale, gray, or blue skin, headache, rapid heart rate, or shortness of breath.

Can I use DenTek™ if I am pregnant?

The safety of DenTek™ during pregnancy has not been evaluated, and it is not recommended due to potential risks.

Is it safe to use DenTek™ while breastfeeding?

Nursing mothers should consult a healthcare professional before using DenTek™, as there is potential for the drug to be excreted in breast milk.

What should I avoid while using DenTek™?

Do not use DenTek™ for teething or in children under 2 years of age.

How should I store DenTek™?

Store DenTek™ at a temperature between 20-25⁰C (68-77⁰F).

Packaging Info

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

Packaging configurations for Dentek Instant Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DenTek™ is an oral anesthetic formulation containing 20% benzocaine, designed for instant pain relief. The product is supplied in a 0.118 fl oz (3.5 mL) bottle, which is packaged as one case containing 50 applicators and one handle.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches, canker sores, cold sores, and sore gums.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the affected area. The application may be performed up to four times daily or as directed by a dentist or physician.

Children between the ages of 2 and 12 years should be supervised during the use of this product to ensure safe and effective application.

The product is not recommended for use in children under 2 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used for teething due to the potential for adverse effects associated with its use in this context. Additionally, it is contraindicated in children under 2 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

Use of this product carries a risk of methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in individuals who have previously used the product without incident. 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 and lack of energy.

Patients with a known allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product.

Healthcare providers should instruct patients to stop using the product and consult a dentist or physician if any of the following occur: development of swelling, rash, or fever; persistence or worsening of irritation, pain, or redness; or if symptoms do not improve within 7 days.

In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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.

Additionally, individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should refrain from using this product due to the risk of allergic reactions.

Patients are advised to discontinue use and consult a dentist or doctor if they experience swelling, rash, or fever, if irritation, pain, or redness persists or worsens, or if symptoms do not improve within 7 days.

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.

Additionally, there is a significant risk of methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition characterized by reduced oxygen transport in the blood, necessitating prompt medical intervention. Monitoring for signs and symptoms of methemoglobinemia is advised, and appropriate treatment should be initiated if this condition is suspected.

Packaging & NDC

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

Packaging configurations for Dentek Instant Pain Relief.
Details

Pediatric Use

Pediatric patients should not use this product for teething. The product is contraindicated in children under 2 years of age. For pediatric patients aged 2 years and older, a small amount of the product may be applied to the affected area up to 4 times daily or as directed by a dentist or doctor. It is recommended that children between 2 and 12 years be supervised during the use of this product to ensure safe application.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy, and its use is not recommended due to potential risks to the fetus. There may be risks associated with the use of benzocaine during pregnancy, which necessitates caution. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product. No specific dosage modifications for pregnant individuals are provided.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can significantly reduce the oxygen-carrying capacity of the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

Healthcare professionals are advised to instruct patients 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to inform patients that this product is not intended for use in teething and should not be administered to children under 2 years of age.

Patients should be instructed to avoid contact with the eyes while using this product. They must not exceed the recommended dosage and should refrain from using the product for more than 7 days unless specifically directed by a healthcare professional, such as a doctor or dentist.

Patients should be made aware that they need to stop using the product and consult a dentist or doctor if they experience any swelling, rash, or fever. Additionally, they should discontinue use and seek medical advice if irritation, pain, or redness persists or worsens. If symptoms do not improve within 7 days, patients should also be advised to stop use and consult a healthcare provider.

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 a controlled temperature range of 20-25⁰C (68-77⁰F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dentek Instant Pain Relief, 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 Dentek Instant Pain Relief, 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.