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Rugged Fit Pain Relief Roll on

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Active ingredients
  • Menthol 2 g/100 mL
  • Methyl Salicylate 10 g/100 mL
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 2025
Label revision date
August 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2 g/100 mL
  • Methyl Salicylate 10 g/100 mL
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 2025
Label revision date
August 1, 2025
Manufacturer
SYSTEM4BOOK LLC
Registration number
M017
NDC root
85826-041
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 temporarily relieve minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, sprains, and bruises. If you're experiencing discomfort from these issues, this drug may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. This includes discomfort from simple backaches, arthritis, strains, sprains, and bruises.

It's important to note that there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects mentioned, making it a safer option for those concerned about these issues.

Dosage and Administration

If you are 12 years old or older, you can apply the medication to the affected area up to three to four times a day. Make sure to follow this schedule to help manage your symptoms effectively.

If you are caring for a child under 12, it’s important to consult a physician (a medical doctor) before using this medication. They can provide guidance on the appropriate treatment for younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help or contact a poison control center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always use medications as directed and consult your healthcare provider if you have any questions or concerns.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only use it externally and avoid applying it to children under 12 years old, on wounds, or on damaged skin, as this could lead to skin blisters. Additionally, do not use it with a heating pad, and be careful to avoid contact with your eyes or mucous membranes.

If you experience excessive irritation, if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. Always ensure you do not bandage the area tightly while using this product.

Warnings and Precautions

This product is for external use only, so please avoid using it on children under 12 years of age, on wounds or damaged skin, or with a heating pad, as this could cause skin blisters. When applying, do not bandage tightly and be careful to keep it away from your eyes and mucous membranes.

If you experience excessive irritation, if your symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek medical help or contact a poison control center immediately.

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 feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. They can provide the necessary guidance and support. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product has not been evaluated during pregnancy. While there are no specific contraindications listed, caution is advised since the effects of menthol and methyl salicylate (ingredients in the product) on pregnancy have not been established.

There is no detailed information available about potential risks to the fetus, and no dosage modifications are provided for pregnant individuals. Therefore, it is crucial to consult your physician before using this product to ensure it is safe for 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to be cautious when considering this medication for children. You should not use it on children under 12 years of age. If your child is under 12, it's best to consult a physician (a medical doctor) for guidance.

For those 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Always follow the recommended guidelines to ensure safety and effectiveness.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply this medication to the affected area up to 3 to 4 times daily if you are an adult or a child aged 12 years or older. If the patient is under 12 years old, it's important to consult a physician first. Remember, this product is for external use only, so do not apply it to children under 12, on wounds or damaged skin, or with a heating pad, as this could cause skin blisters.

While using the medication, avoid wrapping the area tightly and keep it away from your eyes and mucous membranes. If you experience excessive irritation, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. In case of accidental ingestion, seek medical help or contact a poison control center immediately.

FAQ

What does this drug relieve?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

How should I use this drug?

Adults and children 12 years of age or older should apply it to the affected area up to 3 to 4 times daily. Children under 12 years of age should consult a physician.

Are there any contraindications for this drug?

No specific contraindications are listed, but caution is advised, especially for children under 12 years of age.

What should I do if I swallow this drug?

If swallowed, you should get medical help or contact a poison control center right away.

Can I use this drug on wounds or damaged skin?

No, you should not use this drug on wounds or damaged skin, and avoid using it with a heating pad as it may blister the skin.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, so you should consult a physician if you are pregnant or planning to become pregnant.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers.

What should I do if I experience excessive irritation?

You should stop using the product and ask a doctor if excessive irritation develops, symptoms last more than 7 days, or if the condition worsens.

How should I store this drug?

Store the drug at room temperature, protect it from light, and keep the container tightly closed. Discard it after opening.

Packaging Info

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

Packaging configurations for Rugged Fit Pain Relief Roll on.
Details

Drug Information (PDF)

This file contains official product information for Rugged Fit 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 a topical analgesic formulated with an active ingredient of Menthol at a concentration of 3.0% w/w. It contains several inactive ingredients, including Water, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Triethanolamine, and Fragrance. The formulation appears as a clear, colorless to pale yellow liquid.

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 simple backache, arthritis, strains, sprains, and bruises.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area up to three to four times daily. The specific frequency of application may be adjusted based on the severity of the condition and the patient's response to treatment.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate dosage and administration guidelines tailored to the child's needs.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a poison control center if the product is swallowed.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for use in children under 12 years of age and should not be applied in conjunction with a heating pad, as this may lead to skin blistering. Additionally, the product must not be used on wounds or damaged skin.

While using this product, it is essential to avoid tight bandaging and to prevent contact with the eyes or mucous membranes. Should excessive irritation occur, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the user should discontinue use and consult a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the user should contact a poison control center without delay.

Side Effects

Patients should be aware that this product is intended for external use only and is not suitable for children under 12 years of age. It should not be applied in conjunction with a heating pad, as this may lead to skin blistering. Additionally, the product should not be used on wounds or damaged skin.

While using this product, patients are advised to avoid tight bandaging and to prevent contact with the eyes or mucous membranes. In the event of excessive irritation, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. Furthermore, if the condition worsens, it is imperative to seek medical advice.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Rugged Fit Pain Relief Roll on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For children in this age group, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the recommended dosage is to apply the medication to the affected area up to 3 to 4 times daily.

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

The product has not been evaluated for safety in pregnancy. Caution is advised, as the safety of menthol and methyl salicylate during pregnancy has not been established. There is no specific information available regarding risks to the fetus. No dosage modifications are mentioned for pregnant individuals. It is recommended that pregnant patients or those planning to become pregnant consult a physician before use.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a poison control center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with swallowing the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area up to 3 to 4 times daily. For children under 12 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients that the product is for external use only and should not be applied to children under 12 years, on wounds or damaged skin, or in conjunction with a heating pad, as this may cause skin blistering. Patients should avoid tight bandaging, contact with eyes or mucous membranes, and should discontinue use and seek medical advice if excessive irritation occurs, symptoms persist beyond 7 days, or if the condition worsens or recurs shortly after improvement. In the event of ingestion, immediate medical assistance or contact with a poison control center is necessary.

Drug Information (PDF)

This file contains official product information for Rugged Fit 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 Rugged Fit 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.

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.