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Re-Leve

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Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
May 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
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 2016
Label revision date
May 29, 2025
Manufacturer
SOMBRA COSMETICS INC.
Registration number
M017
NDC root
61577-3242
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You may find that this medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It is particularly effective for common issues such as simple backaches, strains, bruises, and sprains.

By targeting these discomforts, this medication can help you feel more comfortable and support your daily activities. If you're experiencing any of these minor pains, this drug may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for common issues such as simple backaches, strains, bruises, and sprains. This means if you’ve had a minor injury or are experiencing discomfort from everyday activities, this medication may help ease your pain.

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

Dosage and Administration

If you or your child is 2 years of age or older, you can apply the gel to the affected area up to 3 to 4 times a day. Make sure to rub the gel in until it is fully absorbed into the skin. This helps ensure that the medication works effectively.

For children under 2 years of age, it’s important to consult your doctor before using this gel. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of some warnings associated with this product. Keep it out of reach of children and use it only on the skin, avoiding contact with your eyes, mucous membranes, wounds, or any damaged skin. Additionally, do not use it with heating pads, as this could lead to complications.

If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and consult a doctor.

Warnings and Precautions

It's important to keep this product out of reach of children and remember that it is for external use only. Be careful to avoid contact with your eyes, mucous membranes, wounds, or any damaged skin. Additionally, do not use this product with heating pads, as this could cause unwanted effects.

If you notice that your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days, you should stop using the product and consult your doctor for further advice.

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 of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no specific information available regarding the use of RE-LEVE menthol gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product for nursing mothers has not been established. There is a possibility that it could be excreted in breast milk, which means it could potentially affect your baby. Therefore, you should exercise caution when considering the use of this product while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your infant.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. This medication is meant for external use only, so it should not be ingested. For children aged 2 years and older, you can apply the gel to the affected area up to 3 to 4 times a day, gently rubbing it in until it is fully absorbed.

If your child is under 2 years old, please consult your doctor before using this product to ensure it is safe and appropriate for them. Always prioritize your child's health and safety when using any medication.

Geriatric Use

While there is no specific information about the use of RE-LEVE menthol gel in older adults, it’s important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can help ensure that it is appropriate for your needs and discuss any potential risks or considerations based on your health status. Always prioritize your safety and well-being when trying new medications or treatments.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backaches, strains, bruises, and sprains.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily and rub until the gel is absorbed.

What should I do if I have a child under 2 years old?

If your child is under 2 years of age, you should consult your doctor before use.

Are there any warnings I should be aware of?

Yes, keep it out of reach of children, use it for external use only, and avoid contact with eyes, mucous membranes, wounds, or damaged skin. Do not use with heating pads.

What should I do if my symptoms worsen or persist?

You should stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is this drug safe to use during pregnancy or while nursing?

The safety of this product has not been established in nursing mothers, and caution should be exercised as there is potential for excretion in breast milk. No specific information regarding pregnancy use is provided.

How should I store this drug?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

Packaging Info

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

Packaging configurations for Re-Leve.
Details

Drug Information (PDF)

This file contains official product information for Re-Leve, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a clear, colorless to pale yellow liquid, packaged in a 4 oz bottle. It contains an active ingredient, the specifics of which are not provided. Additionally, the formulation includes inactive ingredients, details of which are also not specified.

Uses and Indications

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

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 gel to the affected area no more than 3 to 4 times daily. The gel should be gently rubbed into the skin until fully absorbed.

For children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

It is imperative to keep this product out of reach of children. This formulation is intended for external use only and should not be ingested.

Healthcare professionals should advise patients to avoid contact with the eyes, mucous membranes, wounds, or damaged skin. Additionally, the use of heating pads in conjunction with this product is contraindicated.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients should be advised to keep the product out of reach of children and to use it for external purposes only. It is important to avoid contact with the eyes, mucous membranes, wounds, or damaged skin. Additionally, the product should not be used in conjunction with heating pads.

In the event that conditions worsen, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients are instructed to discontinue use and consult a healthcare professional.

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 Re-Leve (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Re-Leve.
Details

Pediatric Use

Pediatric patients should be advised to keep the product out of reach of children and to use it for external purposes only. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily, with gentle rubbing until the gel is fully absorbed. For infants and children under 2 years of age, it is essential to consult a healthcare professional prior to use.

Geriatric Use

There is no specific information regarding the use of RE-LEVE menthol gel 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 efficacy and potential adverse effects is recommended in this population, given the lack of targeted clinical findings for geriatric use.

Pregnancy

There is no specific information regarding the use of RE-LEVE menthol gel during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. As with any medication, the potential risks and benefits should be carefully evaluated in the context of the individual patient's condition and circumstances. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider before using this product.

Lactation

The safety of this product has not been established in lactating mothers. There is a potential for excretion in breast milk; therefore, caution should be exercised when using this product in nursing mothers.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Re-Leve, 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 Re-Leve, 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.