Onetouch Revolution

Description

OneTouch Revolution (NDC 62565-802-01) is a topical anesthetic gel indicated for the anesthesia of accessible mucous membranes. The product is presented in a Strawberry Ice flavor and has a net weight of 1.12 oz (32 g).

Uses and Indications

This drug is indicated for the temporary relief of minor toothache, pain, and sore mouth associated with canker sores, dentures, and orthodontic devices. Additionally, OneTouch Revolution is indicated for the anesthesia of accessible mucous membranes.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to press the top of the container and dispense 0.2 mL of the gel. This amount should then be applied to the desired area using a cotton swab.

Children under the age of 12 should be supervised by an adult during the application process. For children under 2 years of age, it is advised to consult a doctor prior to use.

Contraindications

Use is contraindicated in patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other 'caine' anesthetics, due to the risk of severe allergic reactions. Additionally, the product should not be used for more than 7 days unless directed by a healthcare professional, as prolonged use may lead to adverse effects.

Warnings and Precautions

Use of this product carries a risk of methemoglobinemia, a rare but serious condition characterized by reduced oxygen transport in the blood. This condition can manifest 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

• Fatigue or lack of energy

It is imperative that patients do not exceed the recommended dosage to mitigate the risk of this adverse effect.

In the event of an overdose, patients should be instructed to seek emergency medical assistance or contact the Poison Control Center immediately.

Patients should also be advised to stop using the product and consult a healthcare provider if they experience any of the following: swelling, rash, or fever; or if irritation, pain, or redness persists or worsens. Monitoring for these symptoms is essential to ensure patient safety and effective management of any adverse reactions.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a rare but significant condition that can impair 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 necessary 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.

In addition to the serious risks associated with methemoglobinemia, patients are advised to discontinue use and consult a healthcare professional if they experience swelling, rash, or fever. Persistent or worsening irritation, pain, or redness should also prompt a medical evaluation.

Drug Interactions

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other 'caine' anesthetics, should avoid the use of this medication due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the provided data. Therefore, no additional monitoring or dosage adjustments are recommended based on drug interactions at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this product for teething. It is advised that caregivers consult a doctor before administering the product to infants in this age group. Additionally, children under 12 years of age must be supervised by an adult during use to ensure safety.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns specifically outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information 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

Exceeding the recommended dosage of the medication can lead to serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage and to educate them on the importance of adhering to prescribed dosages.

In the event of suspected overdosage, it is crucial to assess the patient for potential symptoms, which may vary depending on the specific medication involved. Common symptoms associated with overdosage may include, but are not limited to, gastrointestinal disturbances, neurological effects, and cardiovascular complications.

Management of overdosage should be initiated promptly. Healthcare providers should consider supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and, if necessary, implementing specific antidotes or interventions based on the medication's pharmacological profile.

It is essential for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate course of action in cases of overdosage. Additionally, reporting any incidents of overdosage to the appropriate regulatory authorities may be required to ensure patient safety and contribute to ongoing pharmacovigilance efforts.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia, a rare but serious condition associated with the use of this product. Methemoglobinemia can occur even in individuals who have previously used the product without incident, as it reduces the amount of oxygen carried in the blood and requires prompt treatment.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Reported symptoms that may indicate methemoglobinemia 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 this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact the Poison Control Center without delay. Patients should be made aware of the signs of overdose and the importance of prompt action to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20˚ to 25˚ C (68˚ to 77˚ F). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 12 years and older, the recommended dosage is 0.2 mL, which should be dispensed by pressing the top of the container and applied to the desired area using a cotton swab. It is advised that children under 12 be supervised by an adult during administration, and for children under 2 years of age, consultation with a doctor is recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)