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Nanoxtreme Pain Relieving

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Active ingredients
  • Menthol 40 mg/1 mL
  • Methyl Salicylate 100 mg/1 mL
Other brand names
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 2024
Label revision date
October 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 40 mg/1 mL
  • Methyl Salicylate 100 mg/1 mL
Other brand names
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 2024
Label revision date
October 7, 2024
Manufacturer
MG Science Technologies LLC
Registration number
M017
NDC root
84804-321
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 minor aches and pains in your muscles and joints. It can be particularly helpful for discomfort associated with simple backaches, arthritis, strains, and sprains. If you're experiencing these types of pain, this drug may offer you some relief to help you feel more comfortable in your daily activities.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, and sprains. If you're experiencing discomfort from these issues, this medication may help alleviate your pain and improve your mobility.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected areas of your skin. Make sure to do this no more than 3 to 4 times a day for the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product on reddened, damaged, or sensitive skin, as it may cause further irritation. If your condition worsens, or if your symptoms persist for more than 7 days or return shortly after improvement, it’s important to stop using the product and consult a doctor for further guidance.

Side Effects

You should be aware that this product is for external use only and should not be applied to wounds or damaged skin. It is important to wash your hands thoroughly before and after use, and to keep the bottle tightly capped and away from fire or flame. Avoid contact with your eyes, and do not use it on reddened or sensitive skin. If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

Before using this product, talk to your doctor if you are pregnant, breastfeeding, have sensitive skin, are allergic to any ingredients, or are taking prescription medications. Keep this product out of reach of children, and if swallowed, seek medical help or contact the Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so be sure to wash your hands thoroughly before and after using it. It's important to keep the bottle tightly capped and away from fire or flames, as it is flammable. Avoid getting it in your eyes, and do not apply it to wounds or damaged skin. If you have reddened, damaged, or sensitive skin, you should not use this product.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. Before using, talk to your doctor if you are pregnant, breastfeeding, have sensitive skin, are allergic to any ingredients, or are taking prescription medications. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact the Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact the Poison Control Center right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait to see if symptoms improve; getting prompt assistance is crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Additionally, if you have sensitive skin, allergies to any ingredients, or are currently taking prescription medications, you should also seek medical advice. Taking these precautions can help ensure your safety and the well-being of your baby. Always prioritize open communication with your healthcare provider regarding any concerns you may have during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any new medications or products. This is especially crucial if you have sensitive skin, allergies to certain ingredients, or if you are currently taking prescription medications. Your healthcare provider can help ensure that what you use is safe for both you and your baby. Always prioritize open communication with your doctor to address any concerns you may have.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected areas up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and well-being by adhering to these recommendations.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, it's wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are 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 should be used if you have hepatic impairment (issues with liver function).

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are currently taking any prescription medications. This conversation can help ensure that your treatment is safe and effective, as some medications can interact with each other in ways that may affect how well they work.

While there are no specific interactions with laboratory tests mentioned, keeping your healthcare provider informed about all the medications and tests you are undergoing is always a good practice. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place. This helps maintain its quality. Before and after each use, make sure to wash your hands thoroughly to prevent contamination, and always cap the bottle tightly to protect its contents.

Please remember that the product is flammable, so keep it away from any fire or flame to avoid potential hazards. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you can apply the cream to the affected areas up to 3 to 4 times a day. If your child is under 2 years old, it's important to consult a doctor before use.

While using this product, make sure to avoid contact with your mouth, nose, or genitals, and be cautious not to touch these areas while the cream is on your hands. Additionally, do not apply heat, such as heating pads or hot water, to the treated areas. Store the cream in a cool, dry place to maintain its effectiveness.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to affected areas not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned, but do not use it on reddened, damaged, or sensitive skin.

What should I do if my condition worsens?

If your condition worsens or if symptoms persist for more than 7 days, discontinue use and consult a doctor.

Is this drug safe to use during pregnancy or breastfeeding?

You should ask a doctor before use if you are pregnant or breastfeeding.

What precautions should I take when using this drug?

For external use only, avoid contact with eyes, and do not apply to wounds or damaged skin. Wash hands thoroughly before and after use.

What should I do if this drug is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center immediately.

Can I use this drug if I have sensitive skin?

You should ask a doctor before use if you have sensitive skin or are allergic to any ingredients.

How should I store this drug?

Store it in a cool, dry place and keep it tightly capped.

Packaging Info

Below are the non-prescription pack sizes of Nanoxtreme Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nanoxtreme Pain Relieving.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected areas not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The product is contraindicated for use on reddened, damaged, or sensitive skin due to the potential for exacerbating irritation or injury. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution, discontinuation of the product is advised, and consultation with a healthcare professional is recommended.

Warnings and Precautions

For external use only. It is imperative that hands are washed thoroughly before and after each application, and the bottle should be capped tightly after use. The product is flammable; therefore, it must be kept away from fire or flame. Care should be taken to avoid contact with the eyes, and the product should not be applied to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application.

The product should not be used on reddened, damaged, or sensitive skin. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

Prior to use, it is recommended to consult a healthcare provider if the individual is pregnant, breastfeeding, has sensitive skin, is allergic to any ingredients, or is currently taking any prescription medications.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only, and individuals are advised to wash their hands thoroughly before and after each application. The product is flammable; therefore, it should be kept away from fire or flame. Contact with the eyes should be avoided, and it should not be applied to wounds or damaged skin. Additionally, tight bandaging of the area where the product is applied is not recommended.

Patients should not use this product on reddened, damaged, or sensitive skin. If the 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 advised to discontinue use and consult a healthcare professional.

Before using this product, patients are encouraged to consult a doctor if they are pregnant, breastfeeding, have sensitive skin, are allergic to any of the ingredients, or are taking any prescription medications.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Drug Interactions

Patients are advised to consult a healthcare professional prior to using this medication if they are currently taking any prescription medications. This precaution is essential to ensure safety and efficacy, as potential interactions may not be explicitly detailed.

There are no specific drug or laboratory test interactions identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time. However, ongoing assessment of the patient's overall medication regimen is recommended to mitigate any unforeseen interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Nanoxtreme Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nanoxtreme Pain Relieving.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to affected areas up to 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this product. It is important for women who are pregnant, breastfeeding, have sensitive skin, are allergic to any ingredients, or are taking any prescription medications to seek medical advice prior to use. The potential risks and benefits should be carefully considered in these populations to ensure the safety of both the patient and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product if they are breastfeeding, have sensitive skin, are allergic to any ingredients, or are taking any prescription medications. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

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 relation to the use of this medication. Consequently, there are no 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 event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the Poison Control Center should be reached for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to monitor the patient closely for any symptoms that may arise and to initiate appropriate management procedures based on the clinical presentation.

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 provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact the Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to reddened, damaged, or sensitive skin to avoid potential adverse reactions.

Healthcare providers should counsel 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.

Additionally, patients should be encouraged to ask their healthcare provider before using the product if they are pregnant, breastfeeding, have sensitive skin, are allergic to any ingredients, or are currently taking any prescription medications. This ensures that the use of the product is safe and appropriate for their individual health circumstances.

Storage and Handling

The product is supplied in a secure container that must be capped tightly after each use. It is essential to wash hands thoroughly before and after handling the product to ensure safety and hygiene.

For optimal storage, the product should be kept in a cool, dry place, away from any sources of ignition, as it is flammable. Care should be taken to keep the product away from fire or flame to prevent any hazardous situations.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to affected areas no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to avoid contact with the mouth, nose, or genitals while using the cream, and to take care not to touch these areas with hands that have the cream applied. Additionally, patients should refrain from applying heat, such as heating pads or hot water, to the treated areas and are advised to store the product in a cool, dry place.

Drug Information (PDF)

This file contains official product information for Nanoxtreme Pain Relieving, 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 Nanoxtreme Pain Relieving, 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.