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Tokisan

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This product has been discontinued

Active ingredient
Benzocaine 50 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1958
Label revision date
October 19, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 50 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
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 1958
Label revision date
October 19, 2015
Manufacturer
GOYESCAS OF FLA
Registration number
part346
NDC root
11856-5001
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

Benzocaine is a topical anesthetic that contains 5% benzocaine as its active ingredient. It is primarily used for the temporary relief of minor irritation and pain in the mouth and throat, including discomfort from canker sores and minor injuries to the gums. By numbing the affected area, benzocaine helps alleviate soreness and provides protection for irritated tissues.

This medication is designed to ease occasional discomfort, making it a helpful option for those experiencing minor mouth and throat issues. However, it's important to follow usage guidelines and consult a healthcare professional if symptoms persist or worsen.

Uses

You can use this medication for temporary relief from occasional minor irritation, pain, and soreness in your mouth and throat. It is effective for alleviating pain caused by canker sores and can help soothe discomfort from minor irritations or injuries to the mouth and gums. Additionally, it provides protection for irritated areas in your sore mouth and throat, helping you feel more comfortable.

Dosage and Administration

When using this medication, you should apply it to the affected area for at least one minute before spitting it out. This process can be done up to four times a day, or as your doctor advises. If you are using this product for a child under 12 years old, it's important that they are supervised during application to ensure safety and proper use.

If your child is 2 years old, please consult a doctor before using the product to get specific guidance tailored to their needs. Always follow the instructions provided by your healthcare professional to ensure the best results.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dosage. If you experience a severe sore throat that lasts more than two days, or if it is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting, stop using the medication and consult a doctor. Additionally, if your sore mouth symptoms do not improve within seven days, or if you notice any irritation, pain, or redness that worsens, seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication to ensure it is safe for you and your baby.

Side Effects

It's important to be aware of potential side effects when using this medication. You should seek medical help immediately if you experience an overdose or if a child accidentally ingests it. Common side effects may include a sore throat, which can be concerning if it is severe, lasts more than two days, or is accompanied by other symptoms like fever, headache, rash, swelling, nausea, or vomiting. If your sore mouth symptoms do not improve within a week, or if you notice any irritation, pain, or redness that persists or worsens, you should stop using the medication and consult a doctor.

If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this medication to ensure it's safe for you and your baby. Always follow the recommended dosage and keep the medication out of reach of children.

Warnings and Precautions

Keep this medication out of the reach of children to ensure their safety. If you suspect an overdose, it’s important to seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and do not exceed it.

You should stop using this medication and consult your doctor if you experience a severe sore throat, if your sore throat lasts more than two days, or if it is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms in your sore mouth do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, reach out to your healthcare provider. If you are pregnant or breastfeeding, please consult a health professional before using this medication.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure safety and effectiveness. For children aged 2 years and older, you can apply the product to the affected area for at least one minute before having them spit it out. This can be done up to four times a day or as directed by your doctor. However, if your child is under 12 years old, they should be supervised during use to ensure they are using it correctly.

If your child is only 2 years old, it's best to consult with your doctor before using the product. This will help you make sure it's appropriate for their specific needs. Always prioritize your child's safety and follow the recommended guidelines.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential side effects or interactions with other medications that may be more relevant for older individuals. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 for patients with renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

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

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You should take this medication orally, applying it to the affected area for at least one minute before spitting it out. Adults and children aged 2 years and older can use it up to four times a day, or as directed by your doctor. If the user is a child under 12 years old, they should be supervised during use. For children who are 2 years old, it's important to consult a doctor before use.

FAQ

What is Benzocaine used for?

Benzocaine is used for the temporary relief of occasional minor irritation, pain, sore mouth, and throat, as well as pain due to canker sores and minor injuries of the mouth and gums.

What is the recommended dosage for Benzocaine?

Adults and children 2 years of age and older should apply Benzocaine to the affected area for at least one minute and then spit it out, using it up to 4 times daily or as directed by a doctor.

Are there any warnings associated with Benzocaine?

Yes, keep Benzocaine out of reach of children, do not exceed the recommended dosage, and seek medical help in case of overdose. Stop use and consult a doctor if symptoms persist or worsen.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Benzocaine.

How should Benzocaine be stored?

Store Benzocaine at room temperature between 68-77°F (20-25°C) and do not freeze it.

What are the inactive ingredients in Benzocaine?

Inactive ingredients include Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate, and sorbitol.

Packaging Info

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

Packaging configurations for Tokisan.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Benzocaine 5% is an anesthetic agent utilized for its local analgesic properties. The formulation includes several inactive ingredients: benzalkonium chloride, eucalyptus oil, FD&C Red #40, propylene glycol, purified water, sodium bicarbonate, sodium borate, and sorbitol. These components contribute to the stability and efficacy of the product while ensuring appropriate delivery and application.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation, pain, and discomfort associated with sore mouth and throat. It is specifically indicated for pain due to canker sores, as well as pain resulting from minor irritation or injury of the mouth and gums. Additionally, this drug provides minor discomfort relief and protection for irritated areas in cases of sore mouth and sore throat.

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 product should be applied to the affected area for a minimum of one minute, after which it should be expectorated. The application may be performed up to four times daily or as directed by a healthcare professional.

Children under 12 years of age must be supervised during the use of this product to ensure safe and effective application. For children aged 2 years, it is advised to consult a healthcare provider prior to use.

Contraindications

Use is contraindicated in the following situations:

  • Do not exceed the recommended dosage, as this may lead to adverse effects.

  • Discontinue use and consult a healthcare professional if sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens, seek medical advice.

  • Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients not to exceed the recommended dosage, as doing so may lead to adverse effects.

Patients are instructed to discontinue use and consult a physician if any of the following conditions occur:

  • Severe sore throat

  • Sore throat that persists for more than two days

  • Sore throat accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting

  • Symptoms of sore mouth that do not improve within seven days

  • Persistent or worsening irritation, pain, or redness

Additionally, it is essential for individuals who are pregnant or breastfeeding to seek guidance from a healthcare professional prior to using this product to ensure safety for both mother and child.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of the reach of children. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately. Users should not exceed the recommended dosage.

Patients are also instructed to discontinue use and consult a healthcare professional if they experience any of the following: severe sore throat, sore throat that persists for more than two days, sore throat accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Tokisan.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by applying it to the affected area for at least one minute before spitting it out. The product can be used up to four times daily or as directed by a healthcare professional.

For children under 12 years of age, supervision during use is recommended to ensure safety and proper application. Additionally, for pediatric patients specifically aged 2 years, consultation with a doctor is advised prior to use.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 mothers.

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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

No relevant information regarding teratogenic or non-teratogenic effects has been provided. Additionally, there is no available data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that patients must not exceed the recommended dosage to avoid potential adverse effects.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any of the following: a severe sore throat, a sore throat that persists for more than two days, or if the sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. Additionally, patients should be informed to stop use if sore mouth symptoms do not improve within seven days, or if irritation, pain, or redness persists or worsens.

For patients who are pregnant or breastfeeding, it is crucial to recommend that they consult a health professional prior to use to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, within the range of 68-77°F (20-25°C). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the product's quality.

Additional Clinical Information

The product is administered orally, with the recommended application for adults and children aged 2 years and older being to apply to the affected area for at least one minute before spitting it out. It may be used up to four times daily or as directed by a physician. For children under 12 years of age, supervision during use is advised, and consultation with a doctor is recommended for children aged 2 years.

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 Tokisan, 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 Tokisan, 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

Last AI update:

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.