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Onetouch Revolution

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
July 15, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
July 15, 2018
Manufacturer
HAGER WORLDWIDE, INC.
Registration number
part356
NDC root
62565-801
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

OneTouch Revolution is a topical anesthetic gel designed to provide temporary relief from minor toothaches and pain associated with conditions like canker sores, dentures, and orthodontic devices. It works by numbing the affected area in your mouth, helping to alleviate discomfort in your teeth and accessible mucous membranes.

This gel comes in a refreshing cool mint flavor and is available in a 1.12 oz (32 g) tube, making it easy to apply when you need relief.

Uses

If you're dealing with minor toothaches, pain, or soreness in your mouth, this medication can provide temporary relief. It's particularly helpful for discomfort associated with canker sores, dentures, and orthodontic devices.

You can use this treatment to ease your symptoms and make daily activities more comfortable while you manage your oral health. Remember, it's designed for short-term use to help you feel better.

Dosage and Administration

To use this medication, if you are an adult or a child aged 12 years and older, start by pressing the top of the container to dispense 0.2 mL of the gel. You should then apply this amount to the area that needs treatment using a cotton swab.

If you are caring for a child under 12, make sure they are supervised by an adult during the application. For children under 2 years old, it’s important to consult a doctor before using this medication to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid using this medication if you have a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or any other ‘caine’ anesthetics. Additionally, it’s important not to use this medication for more than 7 days unless your doctor or dentist specifically instructs you to do so.

Be mindful that misuse or prolonged use can lead to dependence (a condition where your body becomes reliant on a substance), so always follow your healthcare provider's guidance regarding its use.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child in your care experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, you should stop using the product and consult a doctor if you notice any swelling, rash, or fever, or if you experience persistent or worsening irritation, pain, or redness.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child in your care experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

It's important to follow the recommended dosage and not exceed it. If you suspect an overdose, contact medical help or the Poison Control Center right away. Additionally, if you notice any swelling, rash, or fever, or if irritation, pain, or redness persists or worsens, stop using the product and consult your doctor.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause harmful effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms or if you have taken more than the recommended dose, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. Therefore, it is not recommended for use during this time due to potential risks to your developing baby (fetus).

Before considering this product, you should consult with your healthcare provider to discuss any concerns and explore safer alternatives. Your health and the health of your baby are the top priority, so make sure to seek professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Additionally, there is no information available about whether this product is passed into breast milk or any potential risks it may pose to your baby. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when using this medication for children. If your child is under 2 years old, you should consult a doctor before use, as it is not recommended for teething in this age group. For children under 12, make sure they are supervised by an adult while using the medication to ensure their safety.

Always prioritize your child's health by following these guidelines and seeking professional advice when necessary.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its use. This means that there are no recommended age-related dosage adjustments, safety concerns, or special precautions for elderly patients.

As always, it's important for you or your caregiver to discuss any concerns with your healthcare provider, especially if you have underlying health conditions or are taking other medications. Your doctor can help ensure that this treatment is safe and appropriate for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. These allergies can lead to serious reactions, so make sure to inform your doctor if you have experienced any issues with these types of medications in the past.

While there are no specific interactions with other drugs or laboratory tests mentioned, discussing all your medications and any upcoming tests with your healthcare provider is essential. This ensures your safety and helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20˚ and 25˚ C (68˚ - 77˚ F). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

You will use this medication through a dental application. For adults and children aged 12 and older, press the top of the container to dispense 0.2 mL of gel, then apply it to the desired area using a cotton swab. If you are supervising a child under 12, make sure to assist them during application. For children under 2 years old, it's important to consult a doctor before use.

FAQ

What is OneTouch Revolution?

OneTouch Revolution is a topical anesthetic gel used for the temporary relief of minor toothache, pain, and sore mouth associated with canker sores, dentures, and orthodontic devices.

How do I use OneTouch Revolution?

For adults and children 12 years and over, press the top of the container to dispense 0.2 mL of gel and apply it to the desired area using a cotton swab. Children under 12 should be supervised by an adult.

Are there any contraindications for using OneTouch Revolution?

Do not use OneTouch Revolution if you have a history of allergies to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

What should I do if I experience side effects?

Stop using the product and seek medical attention if you develop swelling, rash, fever, or if irritation, pain, or redness persists or worsens.

Can OneTouch Revolution be used during pregnancy?

The safety of OneTouch Revolution during pregnancy has not been established, and it is not recommended due to potential risks to the fetus. Consult a healthcare provider if pregnant or planning to become pregnant.

What is methemoglobinemia, and how is it related to OneTouch Revolution?

Methemoglobinemia is a rare but serious condition that reduces the amount of oxygen carried in the blood. Use of OneTouch Revolution may cause this condition, so seek immediate medical attention if you or a child develops symptoms like pale or blue skin, headache, or shortness of breath.

How should OneTouch Revolution be stored?

Store OneTouch Revolution at room temperature between 20˚-25˚ C (68˚ - 77˚ F) and protect it from freezing.

Is there any specific information for children regarding OneTouch Revolution?

Children under 2 years of age should consult a doctor before use, and children under 12 should be supervised by an adult when using the product.

Packaging Info

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

Packaging configurations for Onetouch Revolution.
Details

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)

Description

NDC 62565-801-01 identifies OneTouch Revolution, a topical anesthetic gel formulated for oral pain relief targeting teeth and accessible mucous membranes. The product is presented in a Cool Mint 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.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to press the top of the container to 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

The use of this product carries a risk of methemoglobinemia, a rare but serious condition characterized by a reduction in the blood's oxygen-carrying capacity. 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 of this product. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should also be instructed 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. These symptoms may indicate an adverse reaction that requires further evaluation.

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, 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. These reactions highlight the importance of monitoring for adverse effects during treatment.

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 available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Onetouch Revolution.
Details

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. For children under 12 years of age, adult supervision is recommended 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 considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is not recommended during pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product 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 provided regarding 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly to the recommended dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient closely for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific medication involved, but may include a range of adverse effects that necessitate immediate medical attention.

Management of overdosage should involve supportive care and symptomatic treatment. Healthcare providers are advised to implement appropriate interventions based on the clinical presentation of the patient. This may include the administration of activated charcoal if the patient presents within a suitable timeframe, as well as other measures to stabilize the patient’s condition.

In all cases of overdosage, it is essential to contact a poison control center or seek specialized medical assistance to ensure the best possible outcome for the patient. Prompt recognition and management of overdosage can significantly reduce the risk of severe complications.

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 safety profile 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. This condition 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. 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. In the event of an overdose, patients should be instructed to seek medical help immediately or contact the Poison Control Center.

Patients should be informed not to use the medication if they have a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other ‘caine’ anesthetics. It is important to emphasize that the medication should not be used for more than 7 days unless directed by a doctor or dentist.

Additionally, healthcare providers should counsel patients to discontinue use and consult a doctor if they experience any swelling, rash, or fever, or if irritation, pain, or redness persists or worsens.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Onetouch Revolution, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.