Sensicaine Tm Extra

Description

SAFCO SensiCaine™ Extra is a topical anesthetic gel formulated for professional use only. It contains 20% benzocaine as the active ingredient, providing effective local anesthesia. The gel is presented in a 1 oz. (34 g) container and features a Pina Colada flavor, enhancing the user experience during application.

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

For adults and children aged 2 years and older, the recommended dosage is to apply only the amount necessary to the oral mucosa to effectively prevent or relieve pain. It is important to ensure that the application is limited to the affected area to achieve optimal results.

The use of this medication is contraindicated in children under 2 years of age; therefore, it should not be administered to this age group. Healthcare professionals should exercise caution and adhere to these guidelines to ensure patient safety and efficacy of treatment.

Contraindications

Use is contraindicated in the following situations:

• The product should not be used for teething, as it is not indicated for this purpose.

• Use is contraindicated in children under 2 years of age due to safety concerns associated with this age group.

Warnings and Precautions

Use of this product carries significant risks that healthcare professionals must be aware of to ensure patient safety.

Methemoglobinemia Warning The product may induce 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. Immediate cessation of use and prompt medical attention are required if any of the following symptoms develop in the patient or a child under their care: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Allergy Alert This product is contraindicated in patients with a known history of hypersensitivity to local anesthetics, including benzocaine or other "caine" anesthetics. Healthcare professionals should carefully review patient histories to avoid potential allergic reactions.

Sore Throat Warning In cases of severe sore throat that persists beyond 2 days, or if accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a physician promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, referral to a dentist or physician is recommended.

Overdose Management In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt intervention is crucial to mitigate potential complications associated with overdose.

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 known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should avoid using this product due to the risk of allergic reactions.

Patients experiencing a sore throat should be vigilant, particularly if the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. In such cases, it is advisable to consult a healthcare professional promptly. Furthermore, if symptoms related to a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should seek evaluation from a dentist or doctor without delay.

Drug Interactions

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

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Prompt treatment is essential if methemoglobinemia occurs. Monitoring for signs and symptoms of this condition is advised, particularly in patients who may be at higher risk.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years and older, the recommended application is limited to the amount necessary to the oral mucosa to prevent or relieve pain. Care should be taken to ensure that the dosage is appropriate for the individual needs of the pediatric patient.

Geriatric Use

There is no specific information 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the individual circumstances of the patient, including any underlying health conditions and the potential impact on fetal outcomes.

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 drug 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 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.

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 the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

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 question.

Postmarketing Experience

Postmarketing experience has identified cases of methemoglobinemia associated with the use of benzocaine products, including this product. These cases were reported voluntarily or through surveillance programs, contributing to the understanding of the safety profile of benzocaine.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse. In the event of an overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately for guidance.

Additionally, it is important to inform patients to avoid contact with their eyes while using this product. Should contact occur, they should be directed to flush their eyes with water thoroughly to mitigate any potential irritation or harm.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures ranging from 59 to 86ºF (15 to 30ºC). Care should be taken to protect the product from freezing to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. Additionally, patients should be cautioned to avoid contact with the eyes; in the event of contact, they should flush the eyes with water.

Drug Information (PDF)

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

View product document (PDF)