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Asystem Radical Relief Gel Roll-on

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Active ingredients
  • Menthol 0.10 kg/1 kg
  • Methyl Salicylate 0.15 kg/1 kg
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
February 27, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 0.10 kg/1 kg
  • Methyl Salicylate 0.15 kg/1 kg
Other brand names
Dosage form
Gel
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 2023
Label revision date
February 27, 2026
Manufacturer
Cosco International, Inc.
Registration number
M017
NDC root
52261-4902
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 muscles and joints. It can help with discomfort associated with various conditions, including backaches, muscle aches, strains, sprains, bruises, cramps, arthritis, and inflammation.

By targeting these specific types of pain, this drug aims to improve your comfort and mobility, allowing you to engage in daily activities with less discomfort. If you're experiencing any of these minor aches, this medication may be a suitable option for you.

Uses

You can use this medication for temporary relief from minor aches and pains in your muscles and joints. It is effective for conditions such as backaches, muscle aches, strains, sprains, bruises, cramps, arthritis, and inflammation. If you're experiencing any of these discomforts, this medication may help ease your symptoms.

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. Always consult with a healthcare professional if you have any questions or concerns about using it.

Dosage and Administration

When using this medication, make sure to follow the directions provided. You should apply it generously to the affected area and gently massage it in as needed. However, be careful not to use it more than 3 to 4 times a day to avoid any potential issues.

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them. Always prioritize safety and follow the guidelines for the best results.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, and avoid using it with a heating pad. If you are considering using this product for a child under 12 years old who has arthritis-like conditions, please refrain from doing so.

Additionally, be cautious to keep the product away from your eyes. If it does come into contact with your eyes, make sure to flush them thoroughly with water. Following these guidelines will help ensure your safety while using this product.

Side Effects

It's important to use this product only on intact skin and not on wounds or damaged areas. Avoid using it with a heating pad, and do not apply it to children under 12 years old who have arthritis-like conditions. If you notice any redness over the area where you plan to use the product, consult your doctor before proceeding.

While using the product, be careful to keep it away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away.

Do not use this product on wounds or damaged skin, with a heating pad, or on children under 12 years old who have arthritis-like conditions. If you notice any redness over the area you plan to treat, consult your doctor before using it. Be careful to avoid contact with your eyes; if it happens, rinse your eyes thoroughly with water.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help right away. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help immediately. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to consult your doctor before using this medication, as its safety during pregnancy has not been established. While specific risks to the fetus are not detailed, caution is advised. You should only use this medication if it is clearly necessary and after discussing it with your healthcare provider. There are no specific dosage adjustments recommended for pregnant individuals, but always prioritize open communication with your doctor regarding your health and any medications you may need.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on nursing infants have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of your baby.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

For children under 12 years old, you should consult a doctor before using this medication. Additionally, do not use it on children under 12 who have arthritis-like conditions, as this could be harmful. Always prioritize safety and seek professional advice when it comes to your child's health.

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. If you or a loved one is an older adult, it’s wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory).

Always ensure that your doctor is aware of your age and any other health conditions you may have, as this can help them make the best decisions regarding your treatment. Regular check-ins can help monitor how well the medication is working and whether any adjustments are needed for safety and effectiveness.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health concerns during your appointments to receive the best care possible.

Storage and Handling

It appears that there is no specific storage or handling information available for the product or device you are inquiring about. This means you may not need to worry about particular temperature ranges or special handling instructions. However, it's always a good practice to keep any medical product in a clean, dry place and to follow any general safety guidelines provided by your healthcare professional or the product packaging.

If you have any concerns or questions about how to use or store the product safely, please consult your healthcare provider for personalized advice.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for temporary relief of minor aches and pains of muscles and joints associated with conditions like backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation.

How should I use the drug?

You should apply it generously and massage it into the affected area as needed, but do not use more than 3 to 4 times per day.

Are there any contraindications for using this drug?

Yes, do not use it on wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.

What should I do if I accidentally swallow the drug?

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

Is it safe to use during pregnancy?

Safety during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

Can nursing mothers use this drug?

Nursing mothers should consult a healthcare professional before using this product, as there is potential for excretion in breast milk.

What should I do if I have redness over the affected area?

You should ask a doctor before use if you have redness over the affected area.

What precautions should I take while using this drug?

Avoid contact with eyes; if contact occurs, flush thoroughly with water. Keep out of reach of children.

Packaging Info

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

Packaging configurations for Asystem Radical Relief Gel Roll-on.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be used only as directed. It is recommended to apply a generous amount to the affected area and massage gently as needed. The application frequency should not exceed 3 to 4 times per day. For pediatric patients under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

The product is contraindicated for use in the following situations:

  • Application on wounds or damaged skin is prohibited due to the potential for irritation or adverse effects.

  • Concurrent use with a heating pad is not recommended, as it may increase the risk of skin irritation or burns.

  • The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

  • Direct contact with the eyes must be avoided; in the event of contact, the eyes should be flushed thoroughly with water to prevent irritation.

Warnings and Precautions

For external use only. This product should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

The product is contraindicated for use on wounds or damaged skin and should not be applied in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a doctor prior to use if there is any redness present over the affected area. Care should be taken to avoid contact with the eyes; should contact occur, it is essential to flush the eyes thoroughly with water to mitigate potential irritation.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use on wounds or damaged skin and should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age who have arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if they experience redness over the affected area.

While using the product, it is crucial to avoid contact with the eyes. In the event of contact, patients should flush the eyes thoroughly with water.

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 Asystem Radical Relief Gel Roll-on (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Asystem Radical Relief Gel Roll-on.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use. Additionally, this product should not be administered to pediatric patients under 12 years of age who present with arthritis-like conditions.

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

Safety during pregnancy has not been established for this medication. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. While specific potential risks to the fetus are not detailed, caution is advised when considering treatment during pregnancy. There are no specific dosage modifications recommended for pregnant individuals. It is essential to use this medication only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and hives. Additionally, gastrointestinal disturbances have been noted, along with instances of skin irritation.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the medication on wounds or damaged skin, nor in conjunction with a heating pad. Additionally, it is important to caution against use in children under 12 years of age who have arthritis-like conditions.

Healthcare providers should encourage patients to consult a doctor before using the medication if there is any redness over the affected area. Furthermore, patients must be made aware to avoid contact with the eyes; if contact occurs, they should flush the eyes thoroughly with water.

Storage and Handling

The product is supplied in various package configurations, though specific NDC numbers or packaging details were not provided. There are no specific storage or handling conditions outlined in the available information. Therefore, it is recommended that healthcare professionals refer to the product's official labeling for any additional details regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Asystem Radical Relief Gel 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 Asystem Radical Relief Gel 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.

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.