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Quala Topical Anesthetic Gel

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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 2019
Label revision date
January 26, 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 2019
Label revision date
January 26, 2022
Manufacturer
National Distribution & Contracting, Inc
Registration number
part356
NDC root
43128-031
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) applications, specifically as directed by your dentist. It provides temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable. If you're undergoing a dental treatment, this medication can be an effective option to ease discomfort during the process.

Uses

This medication is intended for use in your mouth, specifically for temporary relief from pain that may occur after minor dental procedures. It's important to follow your dentist's instructions on how to use it properly. By using this product as directed, you can help manage discomfort during your recovery.

Dosage and Administration

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

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

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 to watch for 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 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. It’s important not to use 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 assistance 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 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

It's important to always follow the recommended dosage for your medication. If you accidentally take more than the prescribed amount, especially if it's more than what you need for pain relief, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

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

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor 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 physician regarding any medications you may consider during this time.

Pediatric Use

It’s important to know that this medication should not be used in children under 2 years of age. If you notice any concerning symptoms in your child, such as pale, gray, or blue skin (a condition known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or unusual fatigue, you should stop using the medication immediately and seek medical attention.

Always prioritize your child's safety and consult with a healthcare professional if you have any questions or concerns about their health or medication use.

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 for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 those cases.

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 before, so it's crucial to discuss any potential risks 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 a temperature 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, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

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 to ensure it is safe for you and your baby.

FAQ

What is this drug used for?

This drug is used for the temporary relief of pain due to minor dental procedures.

How should I use this drug?

You should apply only the amount needed to the oral mucosa as directed by your dentist.

Who should not use this drug?

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

What should I do if I experience serious side effects?

Stop use and seek immediate medical attention if you or a child develops symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a physician before use.

What precautions should I take when using this drug?

Avoid contact with eyes, and if contact occurs, flush with water. Do not exceed the recommended dosage.

What is methemoglobinemia?

Methemoglobinemia is a serious condition that reduces the amount of oxygen carried in the blood, which can occur with this product.

How should I store this drug?

Store the drug at 59°-86°F (15°-30°C) and protect it from freezing.

Packaging Info

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

Packaging configurations for Quala Topical Anesthetic Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with the letter "A" on one side and the number "1" on the opposite side. Each tablet contains 1 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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.

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 this guideline is strictly followed to ensure patient safety.

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 and 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 due to the risk of severe allergic reactions.

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 are 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 crucial to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed with water immediately.

Patients must adhere to the recommended dosage guidelines. 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 essential 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 advised to discontinue use and seek immediate medical attention if they or a child in their care experience 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.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. Additionally, it is contraindicated for use in children under 2 years of age and should not be used for teething. 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 swelling, rash, or fever develops, patients are advised to consult their physician promptly.

While using this product, patients should avoid contact with the eyes; in the event of contact, the eyes should be flushed with water. 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 immediately. Pregnant or breastfeeding patients should consult a physician before use.

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 Quala Topical Anesthetic Gel (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Quala Topical Anesthetic Gel.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. In the event that a child develops 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, it is imperative to discontinue use and seek immediate medical attention.

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 efficacy, 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. It is important to evaluate the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare professionals are advised to consider the individual circumstances of each patient when making recommendations related to the use of this medication during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Healthcare professionals should be vigilant in monitoring patients for signs of overdosage, particularly if the dosage exceeds the recommended limits.

Should a patient accidentally ingest more than the prescribed amount intended for pain management, immediate medical assistance is necessary. It is advised to contact a Poison Control Center or seek emergency medical help without delay. Prompt intervention is essential to mitigate potential complications associated with overdosage.

Healthcare providers should ensure that patients are educated about the importance of adhering to prescribed dosages and the steps to take in the event of an accidental overdose.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a physician prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

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 requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

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 ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The route of administration for the medication is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Quala Topical Anesthetic Gel, 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 Quala Topical Anesthetic Gel, 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.