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Neuromed Topical Anesthetic

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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
Registration number
M017
NDC root
54723-300
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 pain and itching caused by minor skin irritations. It can help soothe discomfort, allowing you to feel more comfortable in your daily activities. If you're experiencing such symptoms, this product may be a suitable option for you.

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 for treating affected areas on your skin if you are an adult or a child aged two years or older. Simply apply it to the area that needs treatment, but make sure not to do this more than three or four times a day. If your child is under two years old, it's important to consult a physician (doctor) before using the medication.

When applying the medication, use a circular motion for about 50 to 60 seconds. This helps ensure that the medication is evenly distributed and absorbed into the skin for the best results.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

When using this product, it's important to remember that it is for external use only and should not come into contact with your eyes. Avoid applying it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if your symptoms last more than seven days or improve and then return shortly after, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. It's important to keep this product out of reach of children. If someone accidentally swallows it, seek 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 they improve and then come back 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 is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is generally not recommended for use in pregnant women due to potential risks to the developing fetus. If you are considering using this medication, consult your healthcare provider for personalized advice, as there may be risks associated with its use during pregnancy.

Additionally, if you are prescribed this medication while pregnant, your doctor may need to adjust the dosage. Always seek guidance from a healthcare professional before using this product to ensure the safety of both 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area up to three or four times a day. However, if your child is under two years old, it's important to consult a physician (doctor) before using the product. This ensures that you get the best advice for your child's specific needs. Always follow these guidelines to help keep your little one safe and healthy.

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, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

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 ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

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. Children under 2 years of age should consult a physician.

How should I apply this drug?

Apply to the affected area not more than 3 or 4 times daily, using a circular motion for 50 to 60 seconds.

Are there any warnings I should be aware of?

Yes, this product is for external use only, avoid contact with eyes, and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and use is not recommended due to potential risks. Consult a healthcare provider for advice.

Can nursing mothers use this drug?

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

What should I do if the product is swallowed?

If the product is swallowed, get medical help or contact a Poison Control Center right away.

How should I store this product?

Protect this product from excessive heat and direct sun.

Packaging Info

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

Packaging configurations for Neuromed Topical Anesthetic.
Details

Drug Information (PDF)

This file contains official product information for Neuromed Topical Anesthetic, 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 localized discomfort due to various minor skin conditions.

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. For children under two years of age, it is advised to consult a physician prior to use.

When applying the medication, it should be administered in a circular motion for a duration of 50 to 60 seconds to ensure proper absorption and effectiveness.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially over raw surfaces or blistered areas, to prevent adverse effects.

General precautions must be observed to ensure safety. The product should be kept 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.

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. It is essential to monitor the patient's response to treatment and adjust the management plan accordingly.

Side Effects

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

In clinical practice, it is advised not to use the product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

If a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that they stop using the product and consult a healthcare professional.

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 Topical Anesthetic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Neuromed Topical Anesthetic.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under the age of 2 years, it is advised to consult a physician 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to be consulted for personalized advice.

Dosage adjustments may be necessary for pregnant patients, and it is crucial to consult a physician before use. Pregnant women should avoid using this product unless directed by a healthcare professional to ensure the safety of both the mother and the developing fetus.

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

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted in these patients to ensure their safety while on treatment.

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 arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

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 specific overdosage information is not available, 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 use of the compound in these contexts.

Postmarketing Experience

During postmarketing experience, the following adverse reactions have been reported voluntarily or through surveillance programs.

Allergic reactions, including cases of anaphylaxis, have been documented. Skin reactions such as rash, pruritus, and erythema have also been observed. Central nervous system effects, including seizures and dizziness, have been reported. Additionally, cardiovascular effects, including hypotension and bradycardia, have been noted.

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 be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important for patients to be aware of these guidelines to ensure safe and effective use of the product.

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 Topical Anesthetic, 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 Topical Anesthetic, 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.