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Earthmed Fs Pain Relieving Balm

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Active ingredient
Menthol 7.9 g/71.9 g
Other brand names
Dosage form
Salve
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
August 5, 2025
Active ingredient
Menthol 7.9 g/71.9 g
Other brand names
Dosage form
Salve
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
August 5, 2025
Manufacturer
Earthmed LLC
Registration number
M017
NDC root
82876-996

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Drug Overview

FS pain relieving balm is a topical product designed to provide temporary relief from various aches and pains. You can use it for discomfort associated with conditions like arthritis, backache, joint pain, muscle strains, and sprains. This balm works by being applied directly to the skin over the affected area, helping to soothe and alleviate pain.

Uses

If you're dealing with temporary aches and pains, this medication can help provide relief. It's effective for discomfort related to arthritis, backaches, joint pain, muscle strains, and sprains.

You can rely on it to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply the medication to the affected area one to four times a day, depending on your needs. Make sure to follow the instructions carefully for the best results.

If you have a child who is younger than 12 years, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use and dosage for younger patients. Always prioritize safety and follow professional advice when it comes to medication for children.

What to Avoid

It's important to use this product safely. You should not apply it to wounds or irritated skin, and be sure to avoid contact with your eyes. Following these guidelines will help ensure that you use the product effectively and without complications. If you have any questions or concerns about its use, please consult with a healthcare professional.

Side Effects

You should be aware that this product is for external use only and is designed to provide penetrating pain relief. If your condition worsens, if symptoms persist for more than 7 days, or if the issue seems to clear up but then returns within a few days, it’s important to stop using the product and consult a doctor. Additionally, if you experience any rash or irritation, you should also seek medical advice.

Warnings and Precautions

This product is for external use only and is designed to provide penetrating pain relief. It's important to avoid applying it to any wounds or irritated skin, and you should keep it away from your eyes to prevent irritation.

If your condition worsens, if symptoms last more than 7 days, or if the condition clears but then returns within a few days, you should stop using the product and call your doctor. Additionally, if you experience any rash or irritation, discontinue use and consult your healthcare provider.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a poison control center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is essential to consult a health professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Taking this precaution ensures that you make informed decisions for your health and the health of your baby.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your healthcare provider before using any medication. This consultation ensures that you understand any potential risks and benefits for both you and your baby. Your health professional can provide guidance tailored to your specific situation, helping you make informed decisions about your care while nursing.

Pediatric Use

If your child is 12 years old or younger, 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 one to four times a day, depending on the specific instructions. Always remember to keep this medication out of reach of children to 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, it’s important to consult with a healthcare provider for personalized advice. 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. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68-77 degrees Fahrenheit. It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, always do so with clean hands or gloves to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is FS pain relieving balm used for?

FS pain relieving balm is used for temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains.

How should I use FS pain relieving balm?

Adults and children 12 years and over should apply it to the affected area one to four times daily. For children 12 years and younger, consult a doctor.

Are there any warnings for using FS pain relieving balm?

Yes, it is for external use only and should not be applied to wounds or irritated skin. Avoid contact with eyes.

What should I do if my condition worsens while using the balm?

Stop use and consult a doctor if your condition worsens, symptoms last more than 7 days, or if a rash or irritation occurs.

Is FS pain relieving balm safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using FS pain relieving balm.

What should I do if I accidentally apply FS pain relieving balm to my eyes?

If contact with eyes occurs, rinse thoroughly with water and seek medical attention if irritation persists.

How should I store FS pain relieving balm?

Store the balm at 68-77 degrees Fahrenheit and avoid direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Earthmed Fs Pain Relieving Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Earthmed Fs Pain Relieving Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

FS pain relieving balm is presented in an image/jpeg media format. The product is identified by the reference image titled "Earthmed FS pain relieving balm.jpg."

Uses and Indications

This drug is indicated for the temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to apply the medication to the affected area one to four times daily, depending on the severity of the condition.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing instructions.

Contraindications

The product should not be applied to wounds or irritated skin, as this may exacerbate the condition or lead to adverse effects. Additionally, contact with the eyes must be avoided to prevent irritation or injury.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for external application and provides penetrating pain relief.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, the condition resolves but recurs within a few days, or if a rash or irritation develops.

It is crucial to emphasize general precautions to patients. The product should not be applied to open wounds or irritated skin, and care should be taken to avoid contact with the eyes to prevent adverse effects.

In the absence of specific emergency medical instructions, healthcare providers should remain vigilant and encourage patients to seek immediate medical attention if they experience any severe or unexpected reactions.

Side Effects

Patients using this product should be aware that it is intended for external use only and is designed to provide penetrating pain relief.

In clinical practice, participants are advised to stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if the condition appears to resolve but recurs within a few days. Additionally, the occurrence of a rash or irritation necessitates discontinuation of use and medical consultation.

It is important to monitor for these adverse reactions, as they may indicate a need for further evaluation or a change in treatment strategy.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Earthmed Fs Pain Relieving Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Earthmed Fs Pain Relieving Balm.
Details

Pediatric Use

Pediatric patients 12 years and younger should consult a healthcare professional before use. For patients aged 12 years and older, the recommended application is to the affected area one to four times daily. It is important to keep this product out of reach of children to ensure safety.

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 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. It is essential for women of childbearing potential to discuss their individual circumstances and any potential risks with their healthcare provider before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the nursing infant.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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 an overdosage, it is imperative to seek immediate medical assistance or contact a poison control center. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient experiencing an overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse.

Patients should be informed to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or if the condition appears to improve but then recurs within a few days, they should seek medical advice promptly. Additionally, patients should be made aware that if they experience any rash or irritation, they should discontinue use and consult their healthcare provider.

It is important to instruct patients not to apply the medication to wounds or irritated skin, as this may exacerbate the condition. Furthermore, patients should be cautioned to avoid contact with their eyes to prevent irritation or injury.

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 68 to 77 degrees Fahrenheit. Care should be taken to avoid direct sunlight during storage to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Earthmed Fs Pain Relieving Balm, 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 Earthmed Fs Pain Relieving Balm, 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.