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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 2015
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 2015
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 (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. It can be helpful if you're dealing with discomfort from conditions like insect bites, minor cuts, or rashes. By soothing the affected area, it aims to make you feel more comfortable while your skin heals.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. It’s designed to help soothe discomfort and make your skin feel better.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than three or four times a day. If you are treating a child who is under two years old, it's important to consult a physician (doctor) before use to ensure safety and proper care.

To apply 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 recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

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 symptoms last longer than 7 days or improve and then return within a few days, 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 more than 7 days, or if they improve and then come back within a few days. Always prioritize your health and safety when using any medication.

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 signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

The safety of lidocaine hydrochloride cream during pregnancy has not been established, which means that its use could pose potential risks to your developing baby. Because of these concerns, it is advised that you do not use this product while pregnant. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before considering this cream.

Additionally, if you are prescribed this product, your doctor may need to adjust the dosage specifically for you, so be sure to discuss any concerns or questions with them. Your health and the health of your baby are the top priority, so always seek professional advice before using any medication during pregnancy.

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 no more than three to four times a day. However, if your child is under two years old, it's important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child 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, 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 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 liver is functioning well while you are on medication. Your safety and well-being are the top 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 share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

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, 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 primary use of this drug?

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

Who can use this product?

It is intended for adults and children two years or older. Children under 2 years of age should consult a physician.

How should I apply this product?

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

Are there any contraindications for using this product?

Yes, the use of this product is contraindicated in pregnancy due to potential risks to the fetus.

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.

What precautions should I take when using this product?

For external use only, avoid contact with eyes, and do not use in large quantities, particularly over raw surfaces or blistered areas.

What should I do if the product is swallowed?

Get medical help or contact a Poison Control Center right away.

Is it safe to use this product during pregnancy?

The safety of this product during pregnancy has not been established, and pregnant women should consult a healthcare provider before use.

Can nursing mothers use this product?

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 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritation.

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

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 irritation or 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 advised.

Healthcare professionals should instruct 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 patients experience a worsening of their condition, or if symptoms persist for more than 7 days, they should discontinue use and consult a healthcare professional. Additionally, if symptoms clear up and then recur within a few days, it is recommended to stop use and seek medical advice.

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

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. 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

The safety of lidocaine hydrochloride cream during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits. Additionally, dosage adjustments may be necessary for pregnant individuals; therefore, it is essential to consult a physician for guidance on appropriate use and dosing.

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 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 any necessary follow-up.

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

No postmarketing experience details are available in the insert text.

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 for identification. 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

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.