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Nudroxicin Pain Relief Roll-on

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This product has been discontinued

Active ingredients
  • Capsaicin 0.25 mg/1 mL
  • Menthol 60 mg/1 mL
  • Methyl Salicylate 250 mg/1 mL
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
February 6, 2018
Active ingredients
  • Capsaicin 0.25 mg/1 mL
  • Menthol 60 mg/1 mL
  • Methyl Salicylate 250 mg/1 mL
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
February 6, 2018
Manufacturer
NuCare Pharmaceuticals Inc
Registration number
part348
NDC root
70859-028

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Drug Overview

You can use this medication for the temporary relief of minor aches and muscle pains. It is particularly helpful for discomfort associated with conditions like arthritis, simple backache, strains, and muscle soreness or stiffness. This means that if you're experiencing these types of pain, this drug may provide you with some much-needed relief.

Uses

You can use this medication for the temporary relief of minor aches and muscle pains. It is effective for conditions such as arthritis, simple backache, strains, and muscle soreness and stiffness. This means if you're experiencing discomfort from these issues, this medication may help alleviate your pain and improve your mobility.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

Before you start using the product, make sure to shake it well. It’s important to check for any sensitivity by rubbing a small amount on your skin before the first use. Once you’ve done that, you can apply the product directly to the area that needs treatment.

After applying, allow the product to dry completely before coming into contact with clothes or bedding, as it may cause staining. Remember to wash your hands after use to keep everything clean. You can use this product as needed, but be careful not to apply it more than four times in a single day.

What to Avoid

It's important to use this medication safely. You should not apply it to cuts or infected skin, as this can lead to complications. Additionally, avoid using it on children under 12 years old in large amounts, as their bodies may react differently to the medication.

While there are no specific contraindications or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance), always follow the usage guidelines to ensure your safety and well-being. If you have any questions or concerns, please consult your healthcare provider.

Side Effects

If you experience severe, unexplained pain, or if your pain worsens or lasts longer than seven days, it’s important to stop using the medication and consult your physician. Additionally, if you notice any itching or rash, you should also seek medical advice. These reactions may indicate a need for further evaluation.

Warnings and Precautions

You should only use this product on the skin and as directed. Avoid getting it in your eyes, on mucous membranes, or on your genitals. Do not cover the treated area with tight bandages or use it on wounds or damaged skin. It's also important not to use it with a heating pad.

If you are considering using this product for children under 12, please consult a physician first. You should stop using the product and contact your doctor if you experience severe pain that hasn't been diagnosed, if your pain worsens or lasts more than 7 days, or if you develop itching or a rash. Always keep this product out of reach of children.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not indicate whether the product is safe or poses any risks to your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy 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. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about using any product while breastfeeding. They can provide personalized advice based on your individual situation.

Pediatric Use

It's important to be cautious when considering this medication for children. You should not use it in large amounts for children under 12 years old. If your child is younger than 12, it's best to consult with a physician (doctor) before giving them this medication to ensure their safety and proper dosage. Always prioritize your child's health by seeking professional advice when it comes to their medication needs.

Geriatric Use

When considering NuDroxicin Pain Relief Roll-On for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is appropriate and safe based on individual health needs.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best results with your product, store it in a cool place, keeping the temperature below 90°F (32°C). Before each use, give the container a good shake to mix the contents properly. When applying the product, do so directly to the affected area, and make sure it dries completely before coming into contact with clothes or bedding to prevent any staining.

After using the product, remember to wash your hands thoroughly to maintain hygiene and safety. Following these simple steps will help you use the product effectively and safely.

Additional Information

You should apply this product directly to the affected area as needed, but no more than four times a day. Remember, it is for external use only, so avoid contact with your eyes, mucous membranes, or genitals. Do not cover the area with a tight bandage or use it with a heating pad. It's important not to apply it on cuts or infected skin, and it should not be used in large amounts on children under 12 years old.

If you experience severe undiagnosed pain, or if your pain worsens or lasts more than 7 days, or if you develop itching or a rash, stop using the product and consult a physician. Always keep it out of reach of children, and consult a doctor if you are considering using it for a child under 12.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness, and stiffness.

How should I use this product?

Shake the product before each use, apply it directly to the affected area, and allow it to dry before contact with clothes or bedding. Wash your hands after use.

Are there any contraindications for this drug?

There are no specific contraindications mentioned, but do not use it on cuts or infected skin, or on children under 12 years old in large amounts.

What should I do if my pain worsens or persists?

If your pain worsens or persists for more than 7 days, or if you experience itching or a rash, stop use and ask a physician.

Is this drug safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, and no contraindications or associated risks to the fetus are mentioned.

Can nursing mothers use this product?

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

What are the storage instructions for this drug?

Store the product below 90°F (32°C).

How often can I use this product?

You may use the product as necessary, but it should not be used more than four times per day.

What precautions should I take while using this product?

For external use only, avoid contact with eyes and mucous membranes, do not cover or tightly bandage the area, and do not use with a heating pad.

Packaging Info

Below are the non-prescription pack sizes of Nudroxicin Pain Relief Roll-on (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nudroxicin Pain Relief Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Nudroxicin Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness, and stiffness.

There are no teratogenic or nonteratogenic effects reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. Prior to the initial application, it is recommended to rub a small amount of the product on the skin to check for any sensitivity reactions.

The product should be applied directly to the affected area. It is important to allow the application to dry completely before any contact with clothing or bedding to prevent staining. After application, patients should wash their hands thoroughly to avoid unintentional transfer of the product.

The product may be used as necessary; however, it should not be applied more than four times per day.

Contraindications

The product is contraindicated for use on cuts or infected skin due to the potential for exacerbating the condition. Additionally, it should not be used in children under 12 years of age in large amounts, as safety and efficacy have not been established in this population.

Warnings and Precautions

The product is intended for external use only and must be utilized strictly as directed. It is imperative to avoid contact with the eyes, mucous membranes, and genital areas. The affected area should not be covered or tightly bandaged, and the product must not be applied to wounds or damaged skin. Additionally, the use of a heating pad in conjunction with this product is contraindicated.

The product should not be applied to cuts or infected skin, nor should it be used in large amounts on children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical advice if they experience severe undiagnosed pain, if the pain worsens or persists for more than 7 days, or if any itching or rash develops.

It is essential to keep this product out of the reach of children. For children under 12 years of age, consultation with a physician is recommended prior to use.

Side Effects

Patients should discontinue use and consult a physician in the event of severe undiagnosed pain. Additionally, if pain worsens or persists for more than 7 days, medical advice should be sought. Patients are also advised to seek medical attention if they experience itching or a rash during treatment. These reactions warrant careful consideration and prompt evaluation by a healthcare professional to ensure appropriate management and care.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nudroxicin Pain Relief Roll-on (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nudroxicin Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication in large amounts. It is essential for healthcare professionals to consult a physician before administering this medication to children in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of NuDroxicin Pain Relief Roll-On, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the absence of data that may inform the safety and efficacy of the product in this age group. Monitoring for any adverse effects or unexpected responses is advisable when administering this treatment to elderly individuals.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals are encouraged to consider the absence of data when advising pregnant patients and to weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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 based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, even if they are not explicitly detailed in the available literature. Symptoms of overdose can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a physician before using this product in children under 12 years of age. It is important to emphasize that the product should not be applied to cuts or infected skin, nor should it be used in large amounts on children less than 12 years old.

Patients should be instructed to discontinue use and seek medical advice if they experience severe undiagnosed pain, if their pain worsens or persists for more than 7 days, or if they develop itching or a rash. This guidance is crucial for ensuring patient safety and effective use of the product.

Storage and Handling

The product is supplied in a configuration that allows for direct application to the affected area. It is essential to store the product below 90°F (32°C) to maintain its efficacy. Prior to each use, the product must be shaken thoroughly to ensure proper mixing.

To prevent staining, it is important to allow the product to dry completely before any contact with clothing or bedding. Additionally, users should wash their hands after application to maintain hygiene and avoid unintended transfer of the product.

Additional Clinical Information

The product is administered topically, applied directly to the affected area as needed, with a maximum frequency of four times per day. It is intended for external use only, and clinicians should advise patients to follow the directions carefully. Patients should avoid contact with eyes, mucous membranes, or genital areas, and should not cover or tightly bandage the application site. The product should not be used in conjunction with a heating pad, on cuts or infected skin, or in large amounts on children under 12 years of age. Patients are instructed to discontinue use and consult a physician if they experience severe undiagnosed pain, if pain worsens or persists for more than seven days, or if itching or rash occurs. Additionally, the product should be kept out of reach of children, and consultation with a physician is recommended for children under 12.

Drug Information (PDF)

This file contains official product information for Nudroxicin Pain Relief Roll-on, 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 Nudroxicin Pain Relief Roll-on, 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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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.