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Neuromed

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Active ingredient
Benzocaine 20 mg/100 mg
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 mg/100 mg
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cream
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 2016
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, Inc.
Registration number
M017
NDC root
54723-722
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 pain and itching caused by minor skin irritations. Whether you're dealing with a small cut, scrape, or insect bite, this product can help soothe your discomfort. It's important to use it as directed to ensure you get the best results for your skin.

Uses

If you're dealing with minor skin irritation, this medication can provide you with temporary relief from pain and itching. It's designed to help soothe discomfort caused by various skin issues, allowing you to feel more comfortable in your daily activities. Remember, this relief is temporary, so it's important to address the underlying cause of your skin irritation as well.

Dosage and Administration

You can use this medication to help with your condition by applying it directly to the affected area. For adults and children who are two years old or older, you should apply it no more than three to four times a day. This means you can use it several times throughout the day, but be sure not to exceed the recommended amount.

If you have a child who is under two years of age, it's important to consult a physician (doctor) before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

It's important to use this product safely. Keep it out of reach of children to prevent accidental ingestion. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if your condition worsens, if symptoms persist for more than seven days, or if symptoms improve and then return within a few days. Always prioritize your health and safety when using any medication.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or improve and then return within a few days, it's important to stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. It's important to keep it out of reach of children to prevent accidental ingestion. If the product is swallowed, seek medical help immediately or contact a Poison Control Center.

You should stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Your health and safety are important, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

The safety of Benzocaine during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Because of potential risks to the fetus, it is advised that you avoid using Benzocaine if you are pregnant.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using any products containing Benzocaine. They can help you understand the risks and explore safer alternatives for your needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding.

Pediatric Use

When using this product for children aged two years and older, you can apply it to the affected area no more than three or four times a day. However, if your child is under two years old, it's important to consult a physician (a medical doctor) before use. Always keep the product out of reach of children to prevent accidental ingestion. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place, away from excessive heat or direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, be sure to follow any specific instructions provided to avoid damage. Proper care during storage and handling is essential for your safety and the product's longevity.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug is for temporary relief of pain and itching due to minor skin irritation.

Who can use this drug?

Adults and children two years or older can use it. For children under 2 years of age, consult a physician.

How should I apply this drug?

Apply to the affected area not more than 3 or 4 times daily.

What should I do if the condition worsens?

Stop use and ask your doctor if the condition worsens or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should I take when using this drug?

Keep it out of reach of children, avoid contact with eyes, and if swallowed, get medical help or contact a Poison Control Center right away.

What should I do if I accidentally swallow this drug?

Get medical help or contact a Poison Control Center immediately.

Are there any contraindications for this drug?

There are no specific contraindications listed, but it is contraindicated in pregnancy.

Can I use this drug while breastfeeding?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if I experience adverse reactions?

Stop use and ask your doctor if you experience any adverse reactions or if symptoms persist.

Packaging Info

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

Packaging configurations for Neuromed.
Details

Drug Information (PDF)

This file contains official product information for Neuromed, 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 pain and itching associated with minor skin irritation. It is intended for use in patients experiencing such symptoms due to various non-specific skin irritations.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is essential to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriateness of treatment and to receive specific dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. Additionally, discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

General precautions must be observed to ensure safety. The product should be kept out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to stop using the product and seek further medical guidance.

In cases of accidental ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only and should avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a healthcare professional. Discontinuation of use is recommended under these circumstances to ensure safety and efficacy.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Neuromed.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the product to the affected area no more than 3 to 4 times daily. For children under two years of age, consultation with a physician is advised prior to use. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information available 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

The safety of Benzocaine during pregnancy has not been established. Due to potential risks to the fetus, Benzocaine is contraindicated in pregnancy. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this medication to discuss potential risks and alternative options.

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 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 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. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include manifestations such as rash, itching, and hives.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should also be informed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important for patients to understand the significance of these actions to ensure their safety and well-being.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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