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Muscle and Joint Pain Relief Gr Isolate 750 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
78232-002
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 cream is designed to provide relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as arthritis, strains, sprains, simple backaches, and bruises. By applying this pain relief cream, you may find comfort and support for your everyday activities.

Uses

You can use this pain relief cream to help ease minor aches and pains in your muscles and joints. It's effective for conditions like arthritis, strains, sprains, simple backaches, and bruises.

This cream is designed to provide targeted relief, making it a convenient option for managing discomfort associated with everyday activities or injuries. You can feel confident using it, as there are no teratogenic effects (which means it doesn't cause developmental issues in a fetus) or other harmful effects noted.

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 a sufficient amount 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 a day, but be sure not to exceed this frequency. Following these guidelines will help you get the most benefit from the treatment while keeping your skin safe.

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. It's important to 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, 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 contact with your eyes, ears, and mouth. If it does get into your eyes, rinse them thoroughly with water. Do not apply the product more than four times a day, and never bandage tightly or apply it to wounds or damaged skin.

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

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, as this will help healthcare professionals provide the best care. Remember, it's always better to be safe and get help if you are unsure.

Pregnancy Use

The safety of this product during pregnancy has not been established, and it is contraindicated, meaning it should not be used if you are pregnant. There may be potential risks to your fetus associated with its use, so it is crucial to consult your healthcare provider before considering this product. Currently, there are no specific dosage modifications for pregnant individuals, but your health professional can provide guidance tailored to your situation. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

This medication is not safe for use in children, so it's important to avoid giving it to them. Always keep it out of reach of children to prevent accidental ingestion. If a child swallows this medication, seek medical help immediately or contact a Poison Control Center for assistance. Your prompt action can help 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 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 prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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. 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 feel free to ask questions and share your complete list of medications and any lab tests you may have undergone. This way, you can receive the best possible care tailored to your needs.

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, make sure to 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 topically to the affected area no more than 3 to 4 times a day. It is important to remember that this product is for external use only and should not be used in children. When applying, avoid contact with your eyes, ears, and mouth; if contact occurs, rinse your eyes thoroughly with water. Do not apply a tight bandage over the area.

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 clear up and then return within a few days, discontinue use and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is this product used for?

This product is a pain relief cream designed to help reduce minor aches and pains of muscles and joints associated with conditions like arthritis, strains, sprains, simple backaches, and bruises.

How should I apply this cream?

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

Are there any precautions I should take while using this product?

Yes, keep it out of your eyes, ears, and mouth. Do not bandage tightly or apply it to open skin wounds.

What should I do if I experience irritation or rash?

Stop using the product 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, this product should not be used in children.

Can I use this product during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated. Consult a healthcare provider before use.

What should I do if the cream is swallowed?

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

How should I store this product?

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

Packaging Info

Below are the non-prescription pack sizes of Muscle and Joint Pain Relief Gr Isolate 750 mg (pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle and Joint Pain Relief Gr Isolate 750 mg.
Details

Drug Information (PDF)

This file contains official product information for Muscle and Joint Pain Relief Gr Isolate 750 mg, 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 Lidocaine at a concentration of 4% w/w. It contains a variety of inactive ingredients, including Aloe Vera Gel, Carbomer, Ethyl Alcohol, Glycerin, Hydroxyethylcellulose, Methylparaben, Propylene Glycol, Purified Water, Sodium Hydroxide, and Propylparaben. The formulation appears as a clear, colorless to pale yellow gel.

Uses and Indications

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

There are no 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

Contact with eyes must be strictly avoided. In the event of accidental contact, it is imperative to rinse the eyes thoroughly with water. This product is intended for external use only; therefore, it should not be applied to wounds or damaged skin. Additionally, it is crucial to refrain from bandaging the area tightly and to limit application to no more than four times per day.

Healthcare professionals should advise patients 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 instructed to discontinue use and consult a physician if any irritation or rash develops. If the condition worsens or if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, it is essential to stop using the product and seek medical advice.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is crucial to avoid contact with the eyes, as this may lead to irritation. Additionally, the product should not be applied to wounds or damaged skin, and tight bandaging should be avoided to prevent complications. This product is intended for external use only.

In the event of irritation or rash, patients are advised to stop use immediately and consult a healthcare professional. 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 recommended to discontinue use and seek medical advice. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the medication. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Muscle and Joint Pain Relief Gr Isolate 750 mg (pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle and Joint Pain Relief Gr Isolate 750 mg.
Details

Pediatric Use

Pediatric patients should not use this medication. It is essential to keep the 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.

Pregnancy

The safety of this product during pregnancy has not been established, and it is contraindicated in pregnant patients. There may be potential risks to the fetus associated with the use of this product during pregnancy. Due to these concerns, pregnant women are advised to consult a healthcare provider before using this product. No specific dosage modifications for pregnant individuals are provided.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 details regarding overdosage for this product (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms may vary based on the pharmacological profile of the substance involved.

Management Procedures Management of overdosage should be tailored to the individual patient and may include decontamination procedures, such as activated charcoal, if appropriate and within the timeframe of ingestion. Supportive care, including intravenous fluids and monitoring of organ function, may also be warranted.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and consult relevant toxicology resources as needed.

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 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.

Patients should be informed 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.

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

Healthcare providers should counsel patients to discontinue use and consult a physician if irritation or rash develops. Patients should also 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

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients that this product is intended for external use only and should not be used in children. Patients must avoid contact with the eyes, ears, and mouth; in the event of contact with the eyes, they should rinse thoroughly with water.

Additionally, patients should not apply a tight bandage over the area of application. They 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. It is crucial to keep the product out of reach of children, and in case of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Muscle and Joint Pain Relief Gr Isolate 750 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 750 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.