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Neurodexx

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This product has been discontinued

Active ingredients
  • Capsaicin 0.015 g/60 mL
  • Menthol 6 g/60 mL
  • Methyl Salicylate 18 g/60 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
January 16, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Capsaicin 0.015 g/60 mL
  • Menthol 6 g/60 mL
  • Methyl Salicylate 18 g/60 mL
Other brand names
Dosage form
Lotion
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 2021
Label revision date
January 16, 2023
Manufacturer
Rely Wellness
Registration number
part348
NDC root
81649-030
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

Neurodexx™ Pain Relief is a topical pain relief lotion designed to provide fast temporary relief from various types of pain, including arthritis pain, muscular and rheumatic pain, as well as joint pain and stiffness. It is formulated to help alleviate mild pain associated with muscular strain, arthritis, and simple back pain, although it does not cure any diseases.

This product is doctor recommended and formulated, ensuring a level of trust and safety. It has been dermatologically tested to be hypoallergenic, making it suitable for many users. Neurodexx™ is available in two sizes: 120 ml (4 fl oz) and 0.25 gm (0.25 ml).

Uses

If you're experiencing mild pain from conditions like muscular strain, arthritis, or simple back pain, this medication can help provide temporary relief. It's important to note that while it can ease discomfort, it does not cure any underlying diseases.

You can expect fast temporary relief from various types of pain, including arthritis pain, muscular and rheumatic pain, as well as joint pain and stiffness. Always remember to consult with a healthcare professional for advice tailored to your specific situation.

Dosage and Administration

Before using this medication, make sure to follow the instructions provided. Start by shaking the container well before each use. It’s important to test for sensitivity by rubbing a small amount on your skin before the first application. If you experience any irritation, discontinue use.

When applying the medication, gently rub it over the areas that are painful. Allow the area to dry completely before coming into contact with clothes or bedding to prevent any staining. Remember to wash your hands thoroughly after applying the medication. You should not use this product more than four times a day, and if you are pregnant or nursing, it’s best to avoid using it altogether.

What to Avoid

You should avoid using this product if you have cuts or infected skin, as it may worsen the condition. It is also not safe for children under 12 years old, and you should refrain from applying it in large amounts, particularly on raw or blistered skin. If you are allergic to any of the ingredients, including PABA, aspirin products, or sulfa, do not use this product.

Additionally, be mindful that misuse or abuse of this product can lead to dependence (a condition where you may feel unable to function without it). Always follow these guidelines to ensure your safety and well-being.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes, mouth, mucous membranes, or genitals. It's important to avoid tightly bandaging the treated area, using it with a heating pad, or combining it with other topical pain products. Additionally, be cautious as it may stain furniture, clothing, or bedding.

If you experience severe pain that hasn't been diagnosed, or if your pain worsens or lasts more than seven days, you should stop using the product and consult a physician. You should also seek medical advice if your pain goes away and then comes back a few days later, or if you develop itching or a rash.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes, mouth, mucous membranes, or genital areas. Be careful not to let treated skin come into contact with infants or pets, and do not tightly bandage the area or use it with a heating pad or other topical pain products. Additionally, it may stain furniture, clothing, or bedding, so take precautions to protect these items.

You should not use this product on cuts or infected skin, on children under 12 years old, or in large amounts, especially on raw or blistered skin. If you are allergic to any ingredients, including PABA, aspirin products, or sulfa, please avoid using it. If you experience severe pain that is not diagnosed, if your pain worsens or lasts more than 7 days, if it goes away and then comes back, or if you develop itching or a rash, stop using the product and call your doctor.

If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek immediate medical help. It's always better to err on the side of caution when it comes to your health. Remember, if you're ever in doubt, contacting a healthcare professional or poison control can provide you with the guidance you need.

Pregnancy Use

If you are pregnant or nursing, it is important to avoid using this medication. The potential risks to your baby during pregnancy or while breastfeeding are significant, and it is best to prioritize your health and the health of your child. Always consult with your healthcare provider for safe alternatives and guidance tailored to your situation.

Lactation Use

If you are breastfeeding, it's important to be cautious with certain medications. You should avoid using this medication more than four times a day while nursing. Additionally, if you are pregnant or planning to breastfeed, consult your healthcare provider before using it. This will help ensure the safety of both you and your baby. Always prioritize open communication with your doctor about any medications you are considering while breastfeeding.

Pediatric Use

It's important to know that this medication should not be given to children under 12 years old. If you have a child in this age group, please consult your healthcare provider for alternative options. Always prioritize your child's safety and well-being when considering any medication.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to be cautious when using certain medications. For instance, you should avoid using this medication with heating pads or other topical pain products, as combining them can lead to unwanted effects. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to inform your healthcare provider about all the medications you are using. This way, they can provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place where the temperature remains below 90°F (32°C). Keeping it within this temperature range helps maintain its effectiveness and integrity.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that your hands and any surfaces that come into contact with the product are clean. If you have any questions about disposal or further handling, consult the guidelines provided with your product for detailed instructions.

Additional Information

You should use this medication only as directed, applying it topically (on the skin) no more than four times a day. If you are pregnant or nursing, consult your healthcare provider before use.

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately. If the medication gets into your eyes, rinse them with cold water and call your doctor for further advice.

FAQ

What is Neurodexx™ Pain Relief?

Neurodexx™ Pain Relief is a topical pain relief lotion that provides fast temporary relief from arthritis pain, muscular and rheumatic pain, and joint pain and stiffness.

How should I use Neurodexx™ Pain Relief?

You should gently rub the lotion over painful areas, shake before each use, and dry the area before contact with clothes or bedding to avoid staining.

Are there any contraindications for using this product?

Yes, do not use Neurodexx™ on cuts or infected skin, on children under 12 years old, in large amounts over raw or blistered skin, or if you are allergic to any ingredients, PABA, aspirin products, or sulfa.

What should I do if I experience severe pain or a rash?

You should stop using the product and call your doctor if you have severe undiagnosed pain, if pain worsens or persists for more than 7 days, or if itching or rash occurs.

Can I use Neurodexx™ Pain Relief if I am pregnant or nursing?

No, you should not use Neurodexx™ if you are pregnant or nursing.

What are the storage instructions for Neurodexx™ Pain Relief?

Store Neurodexx™ below 90°F (32°C).

What should I do if I accidentally swallow Neurodexx™?

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

Is there any specific information regarding its use in elderly patients?

The insert does not provide specific information regarding geriatric use, dosage adjustments, or safety concerns for elderly patients.

Packaging Info

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

Packaging configurations for Neurodexx.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Neurodexx™ Pain Relief is a topical pain relief lotion formulated to provide fast temporary relief from arthritis pain, muscular and rheumatic pain, as well as joint pain and stiffness. This product is available in a 120 ml (4 fl oz) container and is designed for maximum strength with a hot deep penetrating action. Neurodexx™ is doctor recommended and formulated, ensuring a high standard of efficacy and safety. The lotion has been dermatologically tested and is hypoallergenic, making it suitable for a wide range of users. The product is identified by NDC 81649-030-04 for the 120 ml size and NDC 81649-030-25 for the 0.25 gm (0.25 ml) dosage form.

Uses and Indications

This drug is indicated for the temporary relief of mild pain associated with muscular strain, arthritis, and simple back pain. It provides fast temporary relief from arthritis pain, muscular and rheumatic pain, as well as joint pain and stiffness. It is important to note that this drug does not cure any disease.

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

Dosage and Administration

Healthcare professionals should instruct patients to use the product only as directed. Prior to the first application, it is recommended to rub a small amount on the skin to check for sensitivity. The product should be shaken well before each use to ensure proper consistency.

For application, patients should gently rub the product over the painful areas. It is important to allow the area to dry completely before coming into contact with clothing or bedding to prevent staining. After application, patients should wash their hands thoroughly to avoid unintentional transfer of the product.

Patients should not exceed four applications per day. Additionally, the product is contraindicated for use in individuals who are pregnant or nursing.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application on cuts or infected skin due to the risk of exacerbating the condition.

  • Use in children under 12 years of age, as safety and efficacy have not been established in this population.

  • Application in large amounts, particularly over raw or blistered skin, which may increase the risk of adverse effects.

  • Use in individuals with known allergies to any ingredients in the formulation, including PABA, aspirin products, or sulfa, to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes, mouth, mucous membranes, or genital areas. Care should be taken to prevent treated skin from coming into contact with infants or pets. It is advised not to tightly bandage the treated area, nor should it be used in conjunction with heating pads or other topical pain products. Users should be aware that the product may cause staining on furniture, clothing, or bedding.

General precautions must be observed when using this product. It should not be applied to cuts or infected skin, nor should it be used on children under 12 years of age. Caution is advised when applying large amounts, particularly over raw or blistered skin. Individuals with known allergies to any ingredients, including PABA, aspirin products, or sulfa, should avoid use.

Patients are advised to discontinue use and consult a healthcare professional under the following circumstances: if experiencing severe undiagnosed pain, if pain worsens or persists beyond 7 days, if pain resolves and then recurs within a few days, or if any itching or rash develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to the eyes, mouth, mucous membranes, or genital areas. It is crucial to avoid contact between treated skin and infants or pets. Additionally, patients should refrain from tightly bandaging the treated area, using a heating pad, or combining this product with other topical pain relief products, as these actions may exacerbate adverse effects. Users should also note that the product may stain furniture, clothing, or bedding.

Patients are advised to discontinue use and consult a physician under specific circumstances. These include experiencing severe undiagnosed pain, if pain worsens or persists for more than 7 days, if pain resolves and then recurs within a few days, or if any itching or rash develops. Monitoring for these reactions is essential to ensure safe and effective use of the product.

Drug Interactions

The use of this medication is contraindicated with heating pads, as the combination may lead to increased risk of adverse effects. Additionally, concurrent use with other topical pain products is not recommended due to potential additive effects, which could enhance the risk of local irritation or systemic absorption.

No specific interactions with laboratory tests have been identified; therefore, routine monitoring of laboratory parameters is not necessary when using this medication.

Packaging & NDC

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

Packaging configurations for Neurodexx.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated.

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

Pregnant patients and those who are nursing should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and there is insufficient data to determine its safety profile in this population. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or nursing infants.

Lactation

Lactating mothers are advised not to use this medication more than four times daily. The safety of this medication during lactation has not been established, and it is contraindicated for use in nursing mothers. There is no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider alternative treatments for lactating mothers.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center for guidance on further management strategies.

As always, it is essential to refer to the most current clinical guidelines and institutional protocols when addressing potential overdosage scenarios.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to cuts or infected skin, particularly in children under 12 years of age, or used in large amounts, especially over raw or blistered skin. Patients should also be cautioned against using the product if they have known allergies to any of its ingredients, including PABA, aspirin products, or sulfa.

Providers should emphasize the importance of proper storage, recommending that patients keep the product below 90°F (32°C). Additionally, healthcare providers should discuss the appropriate use of the product for severe undiagnosed pain, advising patients to seek medical attention if their pain worsens or persists for more than 7 days. Patients should also be instructed to consult their healthcare provider if pain resolves and then recurs within a few days, or if they experience any itching or rash following use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a controlled environment, maintaining a temperature below 90°F (32°C) to ensure its stability and efficacy. Proper storage conditions are critical to preserving the integrity of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically and should be used only as directed, with a maximum frequency of four times daily. It is contraindicated for use in pregnant or nursing patients. Clinicians should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. In the event of contact with the eyes, patients should rinse with cold water and consult a physician. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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