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Pain Reliever Cream

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Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 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 2024
Label revision date
March 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 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 2024
Label revision date
March 6, 2024
Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Registration number
M017
NDC root
69396-151
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

Best Choice Muscle Rub Cream is a topical product designed to provide temporary relief from minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. This cream is intended for use on the skin to help soothe discomfort and promote a sense of relief.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're dealing with any of these discomforts, this medication may help ease your symptoms and improve your comfort.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day 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 doctor before use to ensure safety and proper guidance.

After applying the medication, make sure to wash your hands thoroughly with soap and water right away, unless you are treating your hands. This helps prevent the medication from spreading to other areas where it may not be needed.

What to Avoid

It's important to take certain precautions when using this medication. You should avoid contact with your eyes or any mucous membranes, as this can lead to irritation or other issues. Additionally, do not apply a tight bandage over the area where the medication is used, as this may affect its effectiveness or cause unwanted side effects.

By following these guidelines, you can help ensure a safer and more effective experience with your treatment. If you have any questions or concerns, be sure to discuss them with your healthcare provider.

Side Effects

You should be aware that this product is for external use only and should not be applied to wounds, damaged skin, or irritated areas. Additionally, avoid using it with a heating pad. If your condition worsens or does not improve within a week, or if symptoms clear up and then return shortly after, you should stop using the product and consult a doctor. Some users may experience a temporary burning sensation upon application, but this usually goes away within a few days.

If you are pregnant or breastfeeding, it's important to talk to your doctor before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, broken skin, or any irritated areas. Additionally, do not use it in combination with a heating pad, as this could cause unwanted effects.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center right away. It's important to monitor your condition while using this product. If your symptoms worsen or do not improve within 7 days, or if they clear up and then return within a few days, stop using the product and call your doctor. You should also discontinue use and consult your doctor if you experience excessive skin irritation.

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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor 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 professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure safe and effective use for your child.

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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 performance and safety of your product, store it at a controlled room temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, follow them carefully to ensure safe and responsible disposal.

Additional Information

You can use this medication by applying it to the affected area 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 doctor first.

Be sure to avoid getting the medication in your eyes or on mucous membranes, and do not wrap the area tightly with a bandage. If the medication is swallowed, seek medical help or contact a Poison Control Center right away.

FAQ

What is Best Choice Muscle Rub Cream used for?

Best Choice Muscle Rub Cream is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply Best Choice Muscle Rub Cream?

Adults and children 12 years of age or older should apply it to the affected area not more than 3 to 4 times daily. For children under 12 years, consult a doctor.

Are there any warnings for using this cream?

Yes, it is for external use only. Do not use it on wounds or damaged skin, or with a heating pad.

What should I do if I experience excessive skin irritation?

If excessive skin irritation develops, stop using the cream and call your doctor.

Can I use this cream if I am pregnant or breastfeeding?

You should ask a doctor before using Best Choice Muscle Rub Cream if you are pregnant or breastfeeding.

What should I do if the condition worsens or does not improve?

If your condition worsens or does not improve within 7 days, or if symptoms clear up and occur again within a few days, stop use and consult your doctor.

What should I do if I accidentally swallow the cream?

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

How should I store Best Choice Muscle Rub Cream?

Store the cream at controlled room temperature between 20º-25ºC (68º-77ºF).

Packaging Info

Below are the non-prescription pack sizes of Pain Reliever Cream (menthol 10%, methyl salicylate 15%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Reliever Cream.
Details

Drug Information (PDF)

This file contains official product information for Pain Reliever Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Best Choice Muscle Rub Cream 050323 CDER is a topical formulation designed for muscle relief. The product is presented in a cream dosage form, suitable for application to the skin. Specific details regarding its chemical composition, molecular weight, and inactive ingredients are not provided in the extracted facts. The cream is intended for use in alleviating muscle discomfort and is formulated to be absorbed through the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age or older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor prior to use.

Healthcare professionals should advise patients to wash their hands thoroughly with soap and water immediately after application, unless the treatment area involves the hands themselves.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes or mucous membranes should be avoided due to the potential for irritation or adverse reactions. Additionally, tight bandaging is contraindicated as it may lead to compromised circulation or other complications.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged, broken (open), or irritated skin. Additionally, it should not be used in conjunction with a heating pad, as this may lead to adverse effects.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should discontinue use and consult their healthcare provider under the following circumstances: if the condition worsens or fails to improve within 7 days; if symptoms resolve and then recur within a few days; or if excessive skin irritation develops. Monitoring for these signs is essential to ensure patient safety and effective treatment outcomes.

Side Effects

Patients should be aware that the product is intended for external use only and should not be applied to wounds or damaged, broken, or irritated skin. Additionally, it should not be used in conjunction with a heating pad.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if their condition worsens or does not improve within 7 days. They should also seek medical advice if symptoms clear up and then recur within a few days, or if excessive skin irritation develops.

A temporary burning sensation may occur upon application; however, this sensation generally resolves within a few days.

Patients who are pregnant or breastfeeding should consult a healthcare provider before using the product to ensure safety and appropriateness.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever Cream (menthol 10%, methyl salicylate 15%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Reliever Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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

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 healthcare professional prior to using this medication if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. 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 is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be maintained until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be informed that if their condition worsens or does not improve within 7 days, they should consult their healthcare provider. It is important to discuss with patients the possibility of symptoms clearing up only to reoccur within a few days, as this may indicate the need for further evaluation.

Patients should be made aware of the potential for excessive skin irritation and should be instructed to discontinue use and consult their healthcare provider if this occurs. A temporary burning sensation may be experienced upon application; however, patients should be reassured that this sensation typically resolves within a few days.

Healthcare providers should emphasize the importance of avoiding contact with the eyes or mucous membranes to prevent irritation. Additionally, patients should be advised against tightly bandaging the area of application to ensure proper healing and minimize the risk of adverse effects.

For patients who are pregnant or breastfeeding, it is crucial to discuss the safety and appropriateness of using this product during these periods, encouraging them to consult their healthcare provider for personalized advice.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20º-25ºC (68º-77ºF) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging. Special handling needs should be observed to prevent exposure to extreme temperatures or conditions that may compromise the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the area of application. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Pain Reliever Cream, 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 Pain Reliever Cream, 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

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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.