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Muscle and Joint Pain Relief Gr Isolate 350 mg

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This product has been discontinued

Active ingredients
  • Menthol 4 g/100 g
  • Methyl Salicylate 10 g/100 g
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 2021
Label revision date
November 28, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 4 g/100 g
  • Methyl Salicylate 10 g/100 g
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 2021
Label revision date
November 28, 2021
Manufacturer
Clarity Labs LLC
Registration number
part346
NDC root
78232-003
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

Pain relief cream is a topical medication designed to help reduce minor aches and pains in your muscles and joints. It is commonly used for conditions such as arthritis, strains, sprains, simple backaches, and bruises, providing targeted relief where you need it most.

By applying this cream to the affected area, you can experience soothing effects that may help alleviate discomfort and improve your mobility.

Uses

This pain relief cream is designed to help you manage minor aches and pains in your muscles and joints. You can use it for various conditions, including arthritis, strains, sprains, simple backaches, and bruises. Whether you're dealing with discomfort from an injury or chronic pain, this cream can provide targeted relief to help you feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

Dosage and Administration

This product is designed for external use only, meaning you should not ingest it or apply it to any areas of your body that are not affected. To use it, start by placing enough of the product on one hand to fully cover the area that needs treatment. Gently rub the product into the affected area to ensure it is well absorbed.

You can apply this medication up to 3 to 4 times each day. Just remember to follow this guideline to help manage your condition effectively.

What to Avoid

You should avoid using this medication in children, as it is not safe for them. Additionally, do not apply it to open skin wounds, as this could lead to complications. Always follow these guidelines to ensure your safety and well-being.

Side Effects

You should be aware of some important side effects and warnings associated with this product. It is meant for external use only, so avoid contact with your eyes, and do not apply it to wounds or damaged skin. Additionally, do not bandage the area tightly.

If you experience irritation or a rash, stop using the product and consult a doctor. You should also discontinue use if your condition worsens, or if symptoms persist for more than 7 days, or if they clear up and then return within a few days.

Warnings and Precautions

It's important to use this product safely. Remember, it is for external use only, so avoid applying it to wounds or damaged skin, and do not bandage tightly. Keep the product away from your eyes, ears, and mouth. If it accidentally gets into your eyes, rinse them thoroughly with water. You should not use this product more than four times a day.

Make sure to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. If you experience any irritation or rash, or if your condition worsens or does not improve after seven days, stop using the product and consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

There is no specific information available regarding the use of this medication during pregnancy. This means that there are no stated contraindications (conditions that would prevent use) or safety concerns related to pregnancy. Additionally, there are no recommended dosage modifications for pregnant individuals, nor are there any special precautions to consider.

If you are pregnant or planning to become pregnant, it is always best to discuss any medications with your healthcare provider to ensure they are safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to note that there is no specific information available about the use of this medication for nursing mothers or its effects during lactation (the process of producing breast milk). This means that the potential impact on your milk production or your nursing infant is not clearly defined.

If you are breastfeeding or planning to breastfeed, it's a good idea to consult with your healthcare provider to discuss any concerns or questions you may have about this medication and its safety for you and your baby.

Pediatric Use

It is important to know that this medication should not be used in children. To ensure their safety, always keep it out of reach of children. If a child accidentally swallows the medication, seek medical help immediately or contact a Poison Control Center for assistance. Your prompt action can make a significant difference in ensuring their well-being.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while taking any medications.

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, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using 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 15-30°C (59-86°F). It's important to avoid freezing the product or exposing it to excessive heat, which can occur at temperatures above 40°C (104°F).

When handling the product, always do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times a day. Remember, it is for external use only, so avoid contact with your eyes, ears, and mouth. If it does get into your eyes, rinse them thoroughly with water. When applying, do not bandage the area tightly.

If you experience any irritation or rash, stop using the product and consult a doctor. Additionally, if your condition worsens or does not improve after 7 days, or if symptoms return after clearing up, discontinue use and seek medical advice. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the purpose of the pain relief cream?

The pain relief cream helps reduce minor aches and pains of muscles and joints associated with conditions like arthritis, strains, sprains, simple backaches, and bruises.

How should I use the pain relief cream?

Apply enough cream on one hand to cover the affected area and rub it in. Use it no more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, avoid contact with eyes, do not bandage tightly, and do not apply to wounds or damaged skin. This product is for external use only.

What should I do if I experience irritation or rash?

Stop using the cream and consult a doctor if irritation or rash occurs. If symptoms worsen or persist for more than 7 days, discontinue use and seek medical advice.

Is this product safe for children?

No, do not use this product in children or on open skin wounds.

What should I do if the cream is swallowed?

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

What are the storage conditions for the pain relief cream?

Store the cream between 15-30°C (59-86°F) and avoid freezing or excessive heat above 40°C (104°F).

Is there any information about using this cream during pregnancy?

No specific information regarding the use of this cream during pregnancy is provided.

Packaging Info

Below are the non-prescription pack sizes of Muscle and Joint Pain Relief Gr Isolate 350 mg (pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle and Joint Pain Relief Gr Isolate 350 mg.
Details

Drug Information (PDF)

This file contains official product information for Muscle and Joint Pain Relief Gr Isolate 350 mg, 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 minor aches and pains of muscles and joints. It is specifically formulated to address discomfort associated with conditions such as arthritis, strains, sprains, simple backaches, and bruises.

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

Dosage and Administration

This product is intended for external use only. Healthcare professionals should instruct patients to apply a sufficient amount of the product to one hand to adequately cover the affected area. The application should be performed by gently rubbing the product into the affected area.

The recommended frequency of application is no more than 3 to 4 times daily. It is important to ensure that the product is used as directed to achieve optimal results while minimizing the risk of adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be administered to children due to safety concerns related to its effects in this population. Additionally, application on open skin wounds is contraindicated to prevent potential complications and adverse reactions associated with compromised skin integrity.

Warnings and Precautions

The product is intended for external use only and should be applied with caution to prevent adverse effects. Healthcare professionals should advise patients to avoid contact with the eyes, ears, and mouth. In the event of accidental contact with the eyes, it is imperative to rinse thoroughly with water.

Patients should be instructed not to apply the product to wounds or damaged skin, and to refrain from tightly bandaging the area after application. The recommended frequency of application is no more than four times per day to minimize the risk of irritation.

It is crucial to keep this product out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult a physician if any irritation or rash develops. Additionally, if the condition worsens or symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, medical consultation is necessary.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may include irritation or rash, which necessitates immediate discontinuation of use and consultation with a healthcare professional.

In clinical settings, participants have been advised to avoid contact with the eyes, as this may lead to further complications. Additionally, it is important to refrain from applying the product to wounds or damaged skin, and to avoid tight bandaging of the area where the product is applied. This product is intended for external use only.

Patients are also instructed to stop use and seek medical advice if irritation or rash occurs. If the condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, it is recommended to discontinue use and consult a physician.

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 Muscle and Joint Pain Relief Gr Isolate 350 mg (pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle and Joint Pain Relief Gr Isolate 350 mg.
Details

Pediatric Use

Pediatric patients should not use this medication. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy. The prescribing information does not outline any contraindications for pregnant patients, nor does it indicate any safety concerns related to pregnancy. Additionally, there are no specified dosage modifications for individuals who are pregnant, and no special precautions are recommended for use during this period. Healthcare professionals should consider the absence of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this drug in nursing mothers or any lactation considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not established. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation. Documentation of the incident and any interventions performed is crucial for ongoing patient care and safety.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

It is important to inform patients that this product is intended for external use only. They should be cautioned to avoid contact with the eyes, ears, and mouth. If contact occurs, patients should rinse their eyes thoroughly with water.

Patients should also be instructed not to bandage the area tightly when applying this product. Additionally, they should limit the application to no more than four times per day.

Healthcare providers should emphasize the importance of discontinuing use and consulting a physician if irritation or rash develops. Patients should be advised to seek medical advice if their condition worsens, or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

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 15-30°C (59-86°F). Care should be taken to avoid freezing the product, as well as exposure to excessive heat above 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the product to the affected area no more than 3 to 4 times daily. It is intended for external use only, and care should be taken to avoid contact with the eyes, ears, and mouth. In the event of contact with the eyes, they should be rinsed thoroughly with water. Clinicians should advise patients not to bandage the area tightly after application.

Patients are instructed to discontinue use and consult a physician if irritation or rash occurs, if the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution. Additionally, the product should be kept out of reach of children, and immediate medical attention should be sought if swallowed.

Drug Information (PDF)

This file contains official product information for Muscle and Joint Pain Relief Gr Isolate 350 mg, 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 Muscle and Joint Pain Relief Gr Isolate 350 mg, 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.