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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 2022
Label revision date
February 3, 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 2022
Label revision date
February 3, 2022
Manufacturer
Mycone Dental Supply Co. , Inc DBA Keystone Industries and Deepak Products Inc.
Registration number
part356
NDC root
68400-509
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 designed for oral mucosal use only and is typically prescribed by a dentist. It provides temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable during treatment. If you have any questions about its use, be sure to consult your dentist for guidance.

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 for a short period. 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.

If you have a child under 2 years of age, please do not use this medication for them, as it is not recommended for that age group. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

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. Avoid using it for more than 7 days unless your doctor advises otherwise. If your sore mouth symptoms don’t 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. 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 choices 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 doctor before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

It is important to note that this medication should not be used in children under 2 years of age. If your child is using this medication, be vigilant for signs of methemoglobinemia, a condition that can affect the blood's ability to carry oxygen. If you notice any symptoms such as pale, gray, or blue skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, lightheadedness, or unusual fatigue, stop the medication immediately and seek medical attention.

Always consult with your child's healthcare provider for guidance on the appropriate use of this medication and any specific concerns you may have regarding its safety and effectiveness for your child.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be aware of potential interactions when using certain medications. 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 medication 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 any medications or tests with your healthcare provider to ensure your safety and well-being. They can help you understand the risks and make informed decisions about your treatment.

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 to ensure it is safe for you and your baby.

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 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, get 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. Apply only the amount needed to the oral mucosa.

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 presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. This product is supplied in bottles containing 100 tablets.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

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

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, for teething, and for durations exceeding 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should promptly consult their physician.

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 advised amount is accidentally ingested, medical assistance or contact with a Poison Control Center should be sought without delay. Pregnant or breastfeeding patients are advised to consult a physician prior to 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 indicative of methemoglobinemia, such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue and lack of energy, the use of this medication should be discontinued immediately, and urgent medical attention should be sought.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for healthcare providers to evaluate the individual circumstances of women of childbearing potential when prescribing this medication.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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.

Should an individual accidentally ingest more than the prescribed amount intended for pain management, immediate medical assistance is required. 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 on 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. This adverse effect can occur even in individuals who have previously used the product without incident.

No specific information is available 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 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 monitor for 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 the medication out of 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. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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. Proper storage conditions are essential 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.