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Benzocaine

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Active ingredient
Benzocaine 200 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
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
November 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
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
November 18, 2024
Manufacturer
Bellus Medical, LLC
Registration number
M017
NDC root
71888-101
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

This medication is designed to provide temporary relief from discomfort and pain associated with minor burns, skin irritations, minor cuts, scrapes, and itching. It can be used by both adults and children aged 12 years and older to help soothe these common skin issues.

By applying it to the affected area, you can experience relief from the discomfort caused by these minor injuries and irritations. Remember to follow the recommended application guidelines for the best results.

Uses

You can use this medication for the temporary relief of discomfort and pain caused by minor burns, skin irritations, minor cuts, and scrapes. It is also effective in alleviating itching. This means that if you have a small injury or irritation on your skin, this product can help soothe the area and reduce any associated pain or discomfort.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for use.

Dosage and Administration

You should apply the medication to the affected area of your skin, making sure not to exceed 3 to 4 applications each day. This means you can use it several times throughout the day, but be careful not to overdo it.

For both adults and children aged 12 years and older, this dosage is the same. Just remember to apply it directly to the area that needs treatment, and follow this routine consistently for the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (which means relying on a substance to function normally) mentioned in the information provided. Additionally, there are no instructions indicating that you should avoid taking or using this medication under any circumstances. Always remember to follow your healthcare provider's guidance for the best results.

Side Effects

It’s important to use this product only on the skin and to avoid contact with your eyes. If you notice any irritation, if your condition worsens, or if symptoms last longer than seven days, you should stop using the product and consult a doctor. Additionally, if your symptoms improve and then come back within a few days, it’s advisable to seek medical advice.

Please refrain from using this product in large amounts, especially on raw or blistered skin areas, as this could lead to further complications.

Warnings and Precautions

This product is intended for external use only, so be sure to avoid getting it in your eyes. If you notice any skin irritation, if your condition worsens, or if your symptoms last more than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then come back within a few days, it's important to seek medical advice.

Please do not use this product in large amounts, especially on raw or blistered skin areas, as this can lead to further complications. Always prioritize your health and safety by following these guidelines closely.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, you may experience symptoms such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical attention. You should contact your healthcare provider or go to the nearest emergency room right away. If possible, bring the medication container with you to help medical professionals understand what you've taken. Always remember that it's better to be safe and get help if you have any concerns about your health.

Pregnancy Use

Currently, there is no information available about the use of Benzocaine gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

Currently, there is no specific information available about the use of Benzocaine Gel for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make the best decision for you and your baby. Always prioritize safety and seek professional advice when considering medications while breastfeeding.

Pediatric Use

This medication is intended for external use only, so be sure to avoid getting it in your child's eyes. If you have a child who is 12 years old or older, you can apply it to the affected area up to 3-4 times a day. Always remember to keep this product out of reach of younger children to ensure their safety.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. 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 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 and what steps to take for your safety.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. This helps maintain its quality and performance. Additionally, it's important to keep the product out of reach of children to prevent any accidental misuse or ingestion. By following these simple guidelines, you can help ensure safe handling and storage.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of discomfort and pain associated with minor burns, skin irritations, minor cuts, scrapes, and itching.

How should I use the drug?

For adults and children 12 years of age and older, apply to the affected area not more than 3-4 times daily.

Are there any warnings I should be aware of?

Yes, for external use only. Avoid contact with the eyes, and stop use if skin becomes irritated or if the condition worsens or lasts more than 7 days.

What should I do if symptoms reoccur?

If symptoms clear up and then reoccur within a few days, you should stop use and consult a doctor.

Is there any information on use during pregnancy?

There is no information provided regarding the safety or use of this drug during pregnancy.

Can I use this drug on large areas of skin?

No, do not use in large quantities, particularly over raw surfaces or blistered areas.

How should I store the drug?

Store at room temperature and keep out of reach of children.

Packaging Info

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

Packaging configurations for Benzocaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of discomfort and pain associated with minor burns, skin irritations, minor cuts, scrapes, and itching.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the medication to the affected area. The application should not exceed 3 to 4 times daily. Care should be taken to ensure that the medication is applied evenly and adequately to the affected area for optimal efficacy.

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: skin irritation develops, the condition worsens, or symptoms persist beyond 7 days. Additionally, if symptoms resolve and then reappear within a few days, medical advice should be sought.

It is imperative to instruct patients not to use this product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation.

In clinical practice, it is important to monitor for signs of skin irritation. Patients should discontinue use and consult a healthcare professional if any irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then reoccur within a few days, patients are advised to seek medical advice.

The product should not be used in large quantities, especially on raw surfaces or blistered areas, as this may increase the risk of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Benzocaine.
Details

Pediatric Use

Pediatric patients should use this medication for external application only, with strict avoidance of contact with the eyes. For children aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than 3-4 times daily. It is essential to keep this product out of reach of children to prevent accidental ingestion or misuse.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of Benzocaine gel during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal outcomes. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There is no information available regarding the use of Benzocaine Gel in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this medication in lactating mothers and breastfed infants have not been established. Healthcare professionals should exercise caution when considering the use of Benzocaine Gel in this population.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of safeguarding medications and ensuring that they are stored in a secure location.

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. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Benzocaine, 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 Benzocaine, 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.