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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)
Marketed in the U.S.
Since 2017
Label revision date
November 12, 2025
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
Marketed in the U.S.
Since 2017
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, Inc.
Registration number
M017
NDC root
54723-722

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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 works by targeting the affected area to alleviate symptoms, allowing you to feel more comfortable in your daily activities.

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. If you are an adult or a child who is two years or older, you should apply it no more than 3 to 4 times a day.

If your child is under 2 years old, 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 be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return within a few days. Discontinuing use in these situations is crucial for your health and safety.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your well-being by following the recommended instructions.

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 intended for external use only, so please avoid applying it to your eyes. If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to discontinue use in these situations to ensure your safety and well-being.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

When considering the use of Benzocaine cream during pregnancy, it's important to note that the available information does not provide specific guidance on its use. There are no stated safety concerns, contraindications (situations where the drug should not be used), or special precautions for pregnant individuals. Additionally, the insert does not recommend any dosage modifications for those who are pregnant.

As always, if you are pregnant or planning to become pregnant, it's best to consult with your healthcare provider before using any medication, including Benzocaine cream, to ensure it is safe for you and your baby.

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. Currently, 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 medications while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

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

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, it’s important to consult with a healthcare provider before starting the medication. 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 issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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

When handling the product, always do so with care to avoid any damage. Following these simple guidelines will help you use the product safely and effectively.

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?

It is for adults and children two years or older. 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 my condition worsens?

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

Are there any warnings I should be aware of?

Yes, this product is for external use only and you should avoid contact with eyes.

What should I do if the product is swallowed?

Get medical help or contact a Poison Control Center right away if the product is swallowed.

Is this drug safe to use during pregnancy?

There are no specific statements regarding the use of this drug during pregnancy.

Can nursing mothers use this drug?

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

How should I store this product?

Protect this product from excessive heat or direct sun.

Is there any information on drug interactions?

No drug interactions information is provided.

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 specified 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 guidance tailored to the child's needs.

Contraindications

There are no specified contraindications for this product. However, it is advised to 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.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to stop the use of the product and seek medical advice.

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 for patients to monitor their condition closely. If symptoms worsen or persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. This precaution is essential to ensure the safety and well-being of the patient.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 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 three to four times daily. For children under two years of age, it is advised to consult a physician prior to use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Benzocaine cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or precautions related to pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of Benzocaine cream during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

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 use of the compound in these contexts.

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 swelling.

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 necessity of stopping the product and seeking medical advice under these circumstances.

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.

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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.