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Rocksauce Cooling Massage

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Active ingredients
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 20 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 2025
Label revision date
January 29, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 20 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 2025
Label revision date
January 29, 2026
Manufacturer
Implus Footcare, LLC
Registration number
M017
NDC root
81683-007
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 drug is designed to provide soothing heat to sore muscles and joints, helping to relieve discomfort and promote relaxation. It can be particularly beneficial if you're experiencing muscle tension or joint pain, offering a comforting sensation that may aid in your recovery.

Uses

If you're dealing with sore muscles and joints, this product can help by providing soothing heat. The warmth can ease discomfort and promote relaxation, making it a great option for relief after physical activity or a long day. Whether you're recovering from an injury or just need to unwind, this soothing heat can support your comfort and well-being.

Dosage and Administration

To use this lotion effectively, start by applying a generous amount to the area where you feel pain. Gently massage the lotion into your skin until it is fully absorbed. For the best results, you should repeat this process three to four times a day.

Make sure to store the lotion in a cool place, ideally between 68º to 77ºF (20º to 25ºC), to maintain its effectiveness. Following these steps will help you manage your discomfort more effectively.

What to Avoid

It's important to be aware of certain precautions when using this medication. First, you should not use it if you are a child aged 5 years or younger, as it is not safe for that age group. Additionally, please avoid taking the medication by mouth, placing it in your nostrils, or applying it to any wounds or damaged skin. These actions can lead to serious complications and are not recommended.

Always prioritize your safety and follow these guidelines closely to ensure the medication is used correctly and effectively. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid taking it by mouth, placing it in your nostrils, or applying it to wounds or damaged skin. If you have sensitive skin, are pregnant, or breastfeeding, consult a health professional before use. If you experience any irritation, stop using the product immediately.

Keep this product out of reach of children. In case of accidental ingestion, seek medical help or contact the Poison Control Center right away, as it is not intended for children aged 5 years or younger.

Warnings and Precautions

This product is for external use only, so please do not take it by mouth, apply it to your nostrils, or use it on wounds or damaged skin. Always follow the directions provided. If you have sensitive skin, are pregnant, or are breastfeeding, it's important to consult a healthcare professional before using this product.

If you experience any irritation while using it, stop using the product immediately and contact your doctor. Keep this product out of reach of children, and if it is accidentally ingested, seek medical help or call the Poison Control Center right away. This product is not suitable for children aged 5 years or younger.

Overdose

If you or someone else accidentally ingests this medication, it’s important to seek medical help immediately or call the Poison Control Center. This is especially crucial if the person is a child aged 5 years or younger, as this medication is not safe for them.

Signs of an overdose can vary, but if you notice unusual symptoms or behaviors, don’t hesitate to get help. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a healthcare professional before using any new products, especially if you have sensitive skin or are pregnant. This ensures that you receive personalized advice and can make informed decisions about your health and your baby's well-being. Always prioritize open communication with your healthcare provider to address any concerns you may have.

Pediatric Use

It's important to know that this medication is not suitable for children who are 5 years old or younger. If you have younger children, make sure to keep the medication out of their reach to prevent any accidental ingestion.

In the event that a child accidentally takes this medication, seek medical help immediately or contact the Poison Control Center for guidance. Your prompt action can ensure their safety.

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 the standard dosing guidelines apply, but it’s always important for you or your caregiver to discuss any potential risks or considerations with your healthcare provider.

If you are an older adult or caring for one, be sure to monitor for any unusual side effects or changes in health, and communicate these with your doctor. Your healthcare team can help ensure that the medication is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help you understand how to manage your treatment effectively.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68º to 77ºF (20º to 25ºC). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a sterile environment to prevent contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations.

Additional Information

You should apply the lotion liberally to the area of pain and massage it into your skin until it is fully absorbed. This can be done 3 to 4 times a day for best results. Before using the lotion, it's important to consult with a health professional if you have sensitive skin, are pregnant, or are breastfeeding. If you experience any irritation, stop using the product immediately. In the event of accidental ingestion, seek medical help or contact the Poison Control Center right away.

FAQ

What is the primary use of this drug?

The drug provides soothing heat to sore muscles and joints.

How should I apply the lotion?

Apply liberally to the area of pain and massage until absorbed into the skin. Repeat 3-4 times daily.

What is the recommended storage temperature for this drug?

Store at 68º to 77ºF (20º to 25ºC).

Are there any age restrictions for using this drug?

This drug is not for children 5 years or younger.

What should I do in case of accidental ingestion?

Get medical help or call Poison Control Center right away.

Can I use this drug if I have sensitive skin?

Ask a health professional before use if you have sensitive skin.

Is this drug safe to use during pregnancy or breastfeeding?

Consult a health professional before use if you are pregnant or breastfeeding.

What should I do if I experience irritation while using this drug?

Discontinue use if irritation occurs.

Is this drug for internal use?

No, it is for external use only. Do not take by mouth or place in nostrils.

Packaging Info

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

Packaging configurations for Rocksauce Cooling Massage.
Details

Drug Information (PDF)

This file contains official product information for Rocksauce Cooling Massage, 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 relief of discomfort associated with sore muscles and joints through the application of soothing heat. It is designed to provide temporary relief and enhance comfort in affected areas.

Dosage and Administration

The lotion should be applied liberally to the area of pain and massaged into the skin until fully absorbed. This application may be repeated 3 to 4 times daily, depending on the severity of symptoms and individual patient response.

For optimal storage, the lotion should be kept at a temperature range of 68º to 77ºF (20º to 25ºC) to maintain its efficacy.

Contraindications

Use is contraindicated in children aged 5 years or younger. Due to the risk of adverse effects, the product should not be taken orally, placed in the nostrils, or applied to wounds or damaged skin.

Warnings and Precautions

For external use only. This product is not intended for oral ingestion, nasal application, or application to wounds or damaged skin. It is imperative that the product is used strictly as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to consult with them prior to use if they have sensitive skin or if they are pregnant or breastfeeding. This precaution is essential to mitigate any potential adverse reactions.

In the event of irritation, it is recommended that the product be discontinued immediately. Continuous monitoring for any signs of irritation is advised to ensure patient safety.

This product should be stored out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact the Poison Control Center without delay. The product is not suitable for use in children aged 5 years or younger, and this restriction should be clearly communicated to caregivers.

Side Effects

Patients should be aware that this product is for external use only and must not be taken by mouth, placed in nostrils, or applied to wounds or damaged skin. It is essential to use the product as directed to minimize the risk of adverse reactions.

Individuals with sensitive skin, as well as those who are pregnant or breastfeeding, should consult a health professional prior to use. In the event of irritation, it is advised to discontinue use immediately.

This product should be kept out of reach of children. In cases of accidental ingestion, patients or caregivers should seek medical assistance or contact the Poison Control Center without delay. The product is not intended for use in children aged 5 years or younger.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Rocksauce Cooling Massage (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rocksauce Cooling Massage.
Details

Pediatric Use

Pediatric patients under 5 years of age should not use this medication. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this product, especially if they have sensitive skin or are pregnant or breastfeeding. 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

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to 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 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 event of accidental ingestion, it is imperative to seek immediate medical assistance or contact the Poison Control Center. This action is crucial to ensure the safety and well-being of the individual involved.

It is important to note that this medication is not intended for use in children aged 5 years or younger. Healthcare professionals should exercise caution and provide appropriate guidance in such cases to prevent potential adverse effects associated with overdosage.

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

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center in the event of accidental ingestion. It is important to emphasize that the product is not intended for use in children aged 5 years or younger.

Patients should be instructed not to take the product by mouth, place it in their nostrils, or apply it to wounds or damaged skin. They must use the product strictly as directed to ensure safety and efficacy.

Additionally, healthcare providers should encourage patients to consult with a health professional prior to use if they have sensitive skin or if they are pregnant or breastfeeding. Patients should be informed to discontinue use immediately if any irritation occurs, and to report such reactions to their healthcare provider.

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 at a temperature range of 68º to 77ºF (20º to 25ºC) to maintain its efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

Patients should apply the lotion liberally to the area of pain and massage until fully absorbed into the skin, with a recommended frequency of 3-4 times daily. Clinicians should advise patients to consult a health professional prior to use if they have sensitive skin or are pregnant or breastfeeding. Patients are also instructed to discontinue use if irritation occurs and to seek medical assistance or contact the Poison Control Center immediately in the event of accidental ingestion.

Drug Information (PDF)

This file contains official product information for Rocksauce Cooling Massage, 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 Rocksauce Cooling Massage, 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.