Benzodent

Description

Benzodent is a topical anesthetic formulation designed for oral use. It is indicated for the temporary relief of pain associated with minor dental procedures, oral mucosal irritation, and other localized discomforts in the oral cavity. The active ingredient in Benzodent is benzocaine, a local anesthetic that provides rapid onset of action. The product is available in a gel dosage form, characterized by its clear, colorless appearance. Benzodent is formulated to adhere to mucosal surfaces, allowing for prolonged contact and sustained analgesic effect.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor irritation of the mouth and gums. Such irritation may be caused by dentures, orthodontic appliances, or injuries to the mouth and gums.

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

Dosage and Administration

Adults and children aged 12 years and older should remove the cap and break the metal seal using the cap point. The product should be applied directly to the gums or to the surface of the denture that contacts the affected area of the gums. If dentures are being used, it is recommended to wait a few minutes before reinserting them. Regular denture adhesive may be used in conjunction with this product. The product may be used up to four times daily or as directed by a dentist or doctor.

For children under 12 years of age, it is essential to consult a dentist or doctor prior to use. Supervision is required during the application of this product.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for more than 7 consecutive days unless directed by a dentist or a doctor, due to potential risks associated with prolonged use. The product should not be used for teething, as it may not be appropriate for this indication. 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 significant warnings and precautions that healthcare professionals must communicate to patients to ensure safe usage.

Methemoglobinemia Warning The product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms can manifest even in individuals who have previously used the product without issue. Immediate medical attention is required if the patient or a child exhibits any of the following symptoms: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue. Prompt treatment is essential to mitigate the risks associated with this condition.

Allergy Alert Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid using this product. Prolonged or repeated use may lead to localized allergic reactions.

General Precautions It is imperative to avoid contact with the eyes while using this product. Additionally, patients should not exceed the recommended dosage to prevent adverse effects.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Rapid intervention is crucial for both adults and children, even if no symptoms are initially apparent.

Stop Taking and Call Your Doctor Patients should discontinue use and consult a healthcare provider if any of the following occur: sore mouth symptoms do not improve within 7 days; swelling, rash, or fever develops; or if irritation, pain, or redness persists or worsens. These signs may indicate a need for further evaluation and management.

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, patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid using this product due to the risk of localized allergic reactions, which may occur after prolonged or repeated use.

Patients are advised to discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days, or if any of the following symptoms develop: swelling, rash, fever, or if irritation, pain, or redness persists or worsens.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should be supervised when using this product. For children in this age group, it is recommended to consult a dentist or doctor prior to use. The product is contraindicated for teething in children under 2 years of age. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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

The safety of Benzodent (benzocaine) during pregnancy has not been established. Due to potential risks to the fetus, Benzodent is contraindicated in pregnancy. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and alternative options.

Lactation

There are no specific warnings or recommendations regarding the use of Benzodent in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants from the use of Benzodent during lactation.

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 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified that the use of this product may lead to methemoglobinemia, a serious condition characterized by a reduced capacity of blood to carry oxygen. This adverse event can 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.

Additionally, localized allergic reactions have been reported following prolonged or repeated use of the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed that the product should not be used for more than 7 consecutive days unless specifically directed by a dentist or doctor. It is crucial to communicate that this product is not intended for use in teething and should not be administered to children under 2 years of age.

Healthcare providers should instruct patients to discontinue use and consult a doctor or dentist if symptoms of a sore mouth do not improve within 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if they experience swelling, rash, or fever. They should also be cautioned to stop use and consult a healthcare professional if irritation, pain, or redness persists or worsens.

While using this product, patients must be reminded to avoid contact with their eyes and to adhere strictly to the recommended dosage, ensuring they do not exceed the specified amount.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its efficacy. It should be stored at room temperature, away from direct light exposure. To maintain product integrity, the tube must be kept tightly closed when not in use. Any unused product should be discarded after 7 days of opening to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)