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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
43128-033
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.

If you have any questions about how this medication works or its specific uses, be sure to discuss them with your dentist for more personalized information.

Uses

This medication is intended for use in your mouth, specifically for temporary relief from pain that may occur after minor dental procedures. Your dentist will provide guidance on how to use it properly. Remember, it's important to follow their instructions to ensure safe and effective relief.

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 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 guidance provided by your doctor or pharmacist to ensure safe and effective use.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. 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 and seek medical help immediately.

It's important to avoid this product if you have a history of allergies to local anesthetics, such as procaine or benzocaine. Do not use it for more than 7 days unless directed by a doctor, and do not use it for teething or in children under 2 years old. If symptoms do not improve or worsen, contact your physician. 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 doctor 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 them 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. If you notice any of these symptoms, don’t hesitate to get help right away. Always remember to follow the dosage instructions carefully to avoid any risks.

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 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 any medication. This ensures that you receive personalized advice that considers your health and the well-being of your baby. Always prioritize open communication with your healthcare provider to make informed decisions about your care during this time.

Pediatric Use

It’s important to be cautious when using this medication in children. You should not use it for children under 2 years of age. If you notice any unusual symptoms in your child, such as pale, gray, or blue skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the medication immediately and seek medical help.

Always keep this medication out of reach of children to prevent accidental ingestion. Your child's safety is a priority, so be vigilant about monitoring their health while using any medication.

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 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 plan.

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 safely in the past. Always discuss your medical history and any concerns 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 you use the product safely and effectively.

Additional Information

You should be aware that this medication is administered through dental procedures. If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication to ensure it is safe for you.

FAQ

What is the primary use of this drug?

This drug is for oral mucosal use only and provides temporary relief of pain due to minor dental procedures.

How should I apply this drug?

Apply only the amount needed to the oral mucosa to prevent or relieve pain, as directed by your dentist.

Is this drug safe for children?

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

What should I do if I experience symptoms of methemoglobinemia?

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

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

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

How long can I use this drug?

Do not use this drug for more than 7 days unless directed by a physician.

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

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center right away.

Are there any allergy concerns with this drug?

Do not use this drug if you have a history of allergies to local anesthetics such as procaine, butacaine, or benzocaine.

What precautions should I take when using this drug?

Avoid contact with eyes; if contact occurs, flush with water.

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 characterized by its specific chemical name and distinct physical properties. It includes a formulation that comprises various inactive ingredients. The product is available in a defined dosage form and strength, ensuring precise administration. Packaging details are specified, including information presented on the principal display panel. The effective date of this insert is noted as February 26, 2020.

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

Healthcare professionals are advised to apply the necessary amount of the medication directly to the oral mucosa to effectively prevent or relieve pain.

It is important to note that this medication is not recommended for use in children under 2 years of age.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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.

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 seek prompt medical evaluation.

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 adhere to the recommended dosage guidelines. In cases where more than the recommended amount is ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

For individuals who are pregnant or breastfeeding, consultation with a physician is advised prior to use.

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 not use this product. Additionally, it is advised that the product 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 should seek medical advice promptly.

The product is contraindicated for use in teething and in children under 2 years of age. While using this product, patients should avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is also crucial not to exceed the recommended dosage. If more than the recommended amount is accidentally ingested, medical assistance or contact with a Poison Control Center should be sought without delay.

For pregnant or breastfeeding patients, consultation with a physician prior to use is recommended.

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 indicative of methemoglobinemia, such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue, immediate medical attention should be sought.

Additionally, it is important to keep this medication out of reach of children to prevent accidental ingestion or misuse.

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, 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 associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when making recommendations regarding the use of this medication in these populations.

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 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. Exceeding the prescribed amount can lead to serious health complications.

Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is necessary. Healthcare professionals should advise contacting a Poison Control Center or seeking emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a physician prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or 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 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 reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 59° to 86°F (15° to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

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. 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.

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.