Prime-Gel

Description

The product is identified by the National Drug Code (NDC) 77794-018-017.

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.

Healthcare professionals should instruct patients to apply only the amount necessary to the oral mucosa to effectively prevent or relieve pain.

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

Dosage and Administration

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

Patients should not use this product for more than 7 days unless specifically directed by a dentist or physician. It is essential to follow the healthcare provider's instructions regarding the frequency and duration of use to ensure safety and efficacy.

Contraindications

Use is contraindicated in patients who exhibit symptoms of weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin, as these may indicate methemoglobinemia, a rare disorder that can develop up to 2 hours after use. In such cases, it is essential to stop use and consult a healthcare practitioner immediately.

Warnings and Precautions

Patients with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should not use this product.

This product is not intended for use beyond 7 days unless specifically directed by a dentist or physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, it is imperative to seek prompt consultation with a dentist or healthcare provider. Additionally, if any signs of swelling, rash, or fever develop, immediate medical attention is warranted.

Care should be taken to avoid contact with the eyes while using this product. In the event of accidental contact, the affected area should be flushed thoroughly with water.

Healthcare professionals should be vigilant for symptoms indicative of methemoglobinemia, a rare but serious condition. Symptoms may include weakness, confusion, headache, difficulty breathing, and/or a pale, grey, or blue coloration of the skin. These symptoms may manifest up to 2 hours post-application, and if they occur, the patient should discontinue use and consult a healthcare practitioner without delay.

It is crucial not to exceed the recommended dosage. In cases where more than the advised amount has been ingested, immediate medical assistance should be sought, or contact with a poison control center should be established.

For patients who are pregnant or breastfeeding, it is advisable to consult a healthcare professional prior to use.

This product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may include signs of methemoglobinemia, a rare disorder characterized by symptoms such as weakness, confusion, headache, difficulty breathing, and/or pale, grey, or blue-colored skin. These symptoms may appear up to 2 hours after use, and patients are advised to stop use and consult a healthcare practitioner if they experience any of these signs.

Common adverse reactions may include irritation, pain, or redness at the site of application. If these symptoms persist or worsen, or if swelling, rash, or fever develops, patients should seek prompt medical attention from a dentist or doctor.

Patients with a history of allergies to local anesthetics, such as benzocaine or other "caine" anesthetics, should not use this product. It is also important to avoid using the product for more than 7 days unless directed by a healthcare professional.

In the event of accidental ingestion of more than the recommended dosage, patients should seek medical help or contact a poison control center immediately. Additionally, patients are advised to avoid contact with the eyes; if contact occurs, the eyes should be flushed with water.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is recommended prior to use. This product should be kept out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

Patients with a history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should not use this medication due to the potential for severe allergic reactions.

In the event of symptoms such as weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin, it is imperative to discontinue use immediately and consult a healthcare practitioner. These symptoms may indicate the onset of methemoglobinemia, a rare but serious disorder that can manifest within two hours following administration. Monitoring for these signs is essential to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The use of this product is not recommended for more than 7 days unless directed by a dentist or doctor. If symptoms of a sore mouth do not improve within 7 days, or if there is persistent or worsening irritation, pain, or redness, or if any swelling, rash, or fever develops, it is important for caregivers to seek prompt medical attention from a dentist or doctor.

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 healthcare professional 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 healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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. Exceeding the prescribed amount can lead to serious health risks. Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is necessary. Healthcare professionals should advise patients or caregivers to contact a poison control center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly. It is imperative to follow established protocols for the management of overdosage, which may include supportive care and symptomatic treatment as required.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that patients should discontinue use and consult a healthcare practitioner if symptoms such as weakness, confusion, headache, difficulty breathing, and/or pale, grey, or blue-colored skin occur. These symptoms may indicate the presence of methemoglobinemia, a rare disorder that can manifest within two hours following administration.

Patient Counseling

Healthcare providers should advise patients to discontinue use of the medication and seek immediate consultation if they experience any of the following symptoms: weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin. These symptoms may indicate the onset of methemoglobinemia, a rare disorder that can manifest up to 2 hours after administration. It is essential for patients to be aware of these potential signs and to act promptly to ensure their safety.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The route of administration for the medication includes periodontal, dental, and oral applications. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, patients should be instructed to discontinue use and seek medical attention if they experience symptoms such as weakness, confusion, headache, difficulty breathing, or changes in skin color (pale, grey, or blue), as these may indicate methemoglobinemia, a rare disorder that can manifest within two hours of administration.

Drug Information (PDF)

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

View product document (PDF)