Quala Topical Anesthetic Gel

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the other side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

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

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

Dosage and Administration

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 not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

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

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

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

Patients must not exceed the recommended dosage. In cases where more than the advised amount is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be 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 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, or 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. It is also crucial not to exceed the recommended dosage. If more than the recommended amount is accidentally ingested, medical assistance should be sought immediately or contact with a Poison Control Center should be made.

For pregnant or breastfeeding patients, it is recommended 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.

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. In the event that a pediatric patient 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

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is currently no available data on 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 regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance 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 outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

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

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

Nonclinical Toxicology

No specific teratogenic effects have been identified in nonclinical studies. However, it is advised that individuals who are pregnant or breastfeeding consult a physician prior to use.

There are no additional details regarding nonclinical toxicology or animal pharmacology and toxicology available from the studies conducted.

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 the 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 children.

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 medication is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. No further 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)