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Pain Be Gone

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Active ingredient
Menthol 9.6 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
January 29, 2025
Active ingredient
Menthol 9.6 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
January 29, 2025
Manufacturer
Back to Earth Inc.
Registration number
M014
NDC root
82721-001

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Drug Overview

This medication is 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. The drug works by delivering penetrating pain relief, helping you feel more comfortable and active.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. This includes discomfort from simple backaches, arthritis, strains, bruises, and sprains. If you're experiencing penetrating pain, this medication can also help provide relief.

It's important to note that there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You can use this medication by applying it directly to the affected area of your skin. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. If you have a child who is under 2 years of age, it’s important to consult a physician or doctor before using this medication.

Make sure to follow these guidelines closely to ensure safe and effective use. Always apply the medication to the specific area that needs treatment, and remember not to exceed the recommended frequency of applications.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns regarding dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a doctor. Additionally, do not apply it to wounds or damaged skin, and avoid tightly bandaging the area. Always keep the product out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. It's important not to apply it to any wounds or damaged skin, and avoid wrapping the area tightly with a bandage.

Keep this product out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Overdose

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but acting quickly is crucial for safety.

If you or someone else may have taken too much, don’t wait for symptoms to appear. Call for help right away to ensure proper care and guidance. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the product does not have specific information about its use during pregnancy. However, the available information does not mention any safety concerns, contraindications (situations where the product should not be used), or the need for dosage adjustments while pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of PAIN BE GONE menthol cream for nursing mothers or during lactation (the period of breastfeeding). This means that it’s unclear how this product may affect you or your baby while you are breastfeeding.

If you are considering using this cream while nursing, it’s a good idea to consult with your healthcare provider to discuss any potential risks or concerns. They can help you make an informed decision that prioritizes your health and the well-being of your infant.

Pediatric Use

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a physician or doctor before use to ensure their safety.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always follow their guidance on dosage and safety to ensure the best outcomes.

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 you understand any necessary precautions or adjustments based on your kidney health.

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 (issues with liver function).

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best use of your product, store it at room temperature and protect it from light. When not in use, make sure to keep the tube tightly closed to maintain its integrity. If you open the product but do not use it within a specified time frame, be sure to discard it to ensure safety and effectiveness. Additionally, always keep the product out of reach of children to prevent any accidental exposure.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, consult a physician or doctor before use. Remember, this product is for external use only, so avoid contact with your eyes. If your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and consult a physician.

Additionally, do not apply the product to wounds or damaged skin, and avoid tightly bandaging the area. Keep the product out of reach of children, and in case of overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug 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 this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a physician.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

This drug is for external use only. Avoid contact with the eyes, do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do in case of overdose?

Keep this drug out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Is this drug safe to use during pregnancy?

There is no specific information regarding the use of this drug during pregnancy.

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use.

What should I do if my symptoms persist?

If conditions worsen or if symptoms persist for more than 7 days, discontinue use and consult a physician.

Packaging Info

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

Packaging configurations for Pain Be Gone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including conditions such as simple backache, arthritis, strains, bruises, and sprains. It is also indicated for penetrating pain relief.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician or healthcare provider prior to use to determine the appropriate course of action.

The medication should be applied directly to the affected area, ensuring that the skin is clean and dry before application. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. Should conditions worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a physician should be consulted.

This product must not be applied to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application, as this may lead to adverse effects.

Healthcare professionals should ensure that this product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. In the event that conditions worsen, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a physician.

Additionally, the product should not be applied to wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied. To ensure safety, the product should be kept out of reach of children. In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Pain Be Gone.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is necessary prior to use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The product does not contain specific information regarding its use during pregnancy. Currently, there are no stated safety concerns, contraindications, or dosage modifications for use during pregnancy. Healthcare professionals should consider the absence of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled accordingly.

Lactation

There is no information available regarding the use of PAIN BE GONE menthol cream in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating patients.

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 event of an overdose, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients and caregivers to keep the medication out of reach of children to prevent accidental ingestion.

If an overdose occurs, it is imperative to seek medical help or contact a Poison Control Center without delay. Prompt intervention can significantly mitigate potential risks 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its efficacy. When not in use, the tube should be kept tightly closed to prevent contamination. If the product is not utilized within a specified time frame after opening, it should be discarded. Additionally, it is crucial to keep the product out of reach of children to ensure safety.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should not come into contact with the eyes. If conditions worsen, or if symptoms persist for more than 7 days or recur shortly after resolution, patients should discontinue use and consult a physician. The product should not be applied to wounds or damaged skin, and it should not be bandaged tightly. Additionally, it is important to keep the product out of reach of children, and in the event of an overdose, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Pain Be Gone, 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 Be Gone, 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.