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Re-Leve Footlube Pain Relief

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This product has been discontinued

Active ingredient
Menthol 0.03 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
November 28, 2022
Active ingredient
Menthol 0.03 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
November 28, 2022
Manufacturer
SOMBRA COSMETICS INC.
Registration number
part348
NDC root
61577-5042

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If you are a consumer or patient please visit this version.

Drug Overview

This product is designed to help detoxify your joints and provide relief for sore feet, athlete's foot, foot odor, perspiration, and coldness. If you spend long hours on your feet, it can soothe and alleviate pain, making it a supportive option for those who experience discomfort from standing or walking for extended periods.

Uses

You can use this product for various foot-related issues. It helps detoxify your joints, providing relief from discomfort and pain. If you have sore feet, this product can soothe them, making it easier to get through your day.

Additionally, it effectively treats athlete's foot, a common fungal infection, and helps reduce foot odor. If you often experience perspiration and coldness in your feet, this product can alleviate those symptoms as well. After long hours of standing, you’ll find that it soothes and relieves pain, allowing you to feel more comfortable.

Dosage and Administration

To get the best results from your medication, make sure to apply it before you put on your socks and shoes. This will help ensure that the medication works effectively. Remember, applying it at the right time is key to your treatment.

What to Avoid

It's important to keep this medication out of the reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to be aware of some key warnings when using this product. Keep it out of the reach of children and remember that it is for external use only. Avoid contact with your eyes, mucous membranes, wounds, or any damaged skin. Store the product at room temperature and do not use it with heating pads. If your symptoms do not improve within one week, please consult your doctor.

While using this product, if you experience any unusual reactions or side effects, it's essential to seek medical advice promptly. Always prioritize your safety and well-being.

Warnings and Precautions

It's important to keep this product out of the 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, as this can cause irritation. Store the product at room temperature and do not use it with heating pads, as this could affect its safety and effectiveness.

If you notice that your symptoms do not improve within one week, please consult your doctor. While using this product, if you experience any unusual reactions or side effects, stop using it immediately and reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case 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, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product should be avoided during pregnancy, nor does it provide any dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication or product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the information provided about Re-LEVE Footlube Pain Relief. This means that, based on the available data, it is generally considered safe for you to use this product while breastfeeding.

However, it's always a good idea to consult with your healthcare provider before starting any new medication or treatment to ensure it aligns with your individual health needs and circumstances.

Pediatric Use

It's important to keep this product out of the reach of children to ensure their safety. Remember, this medication is for external use only, so you should avoid letting it come into contact with your child's eyes, mucous membranes (the moist tissue lining certain body parts), wounds, or any damaged skin. Always supervise its use to prevent any accidental exposure.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of the reach of children to prevent any accidental misuse. Additionally, avoid using the product with heating pads, as this could compromise its integrity or function. By following these simple guidelines, you can help maintain the product's quality and ensure safe handling.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is the primary use of this drug?

This drug detoxifies joints and relieves sore feet, athlete's foot, foot odor, perspiration, and coldness. It also soothes and relieves pain after long hours of standing.

How should I apply this drug?

You should apply it before putting on socks and shoes.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

Is this drug safe to use during pregnancy?

There are no specific warnings or contraindications regarding use during pregnancy mentioned.

What precautions should I take when using this drug?

Keep it out of the reach of children, avoid contact with eyes and mucous membranes, and do not use it with heating pads.

What should I do if my symptoms do not improve?

If symptoms do not respond within one week, you should see a doctor.

What are the storage instructions for this drug?

Store the drug at room temperature.

Is this drug for external use only?

Yes, this drug is for external use only.

Packaging Info

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

Packaging configurations for Re-Leve Footlube Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the detoxification of joints and the relief of sore feet. It is effective in treating athlete's foot and reducing foot odor. Additionally, this drug alleviates perspiration and coldness, and it soothes and relieves pain associated with prolonged standing.

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

Dosage and Administration

Healthcare professionals should instruct patients to apply the medication prior to putting on socks and shoes. This ensures optimal absorption and effectiveness of the treatment. It is important to emphasize the necessity of this application step in the overall administration process.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of the reach of children. This precaution is essential to prevent accidental ingestion or misuse by minors. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children. The formulation is intended for external use only and should not be applied to the eyes, mucous membranes, wounds, or damaged skin to prevent adverse reactions.

Storage conditions are critical; the product must be stored at room temperature and should not be used in conjunction with heating pads, as this may alter its efficacy or safety profile.

Healthcare professionals should advise patients to seek medical attention if symptoms do not improve within one week of use. It is important to note that ReLEVE Products does not make any medical claims regarding the efficacy of this product.

Side Effects

Patients should be advised to keep the product out of the 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. The product should be stored at room temperature and should not be used in conjunction with heating pads.

In the event that symptoms do not improve within one week, patients are encouraged to consult a healthcare professional. It is essential to note that ReLEVE Products does not make any medical claims regarding the efficacy of the product.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Re-Leve Footlube Pain Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep the product out of reach to prevent accidental ingestion or misuse. The product is intended for external use only; therefore, it is crucial to avoid contact with the eyes, mucous membranes, wounds, or damaged skin in children.

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 be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Re-LEVE Footlube Pain Relief. Lactating mothers may use this product without concern for adverse effects on breastfed infants, as no data on excretion in breast milk or effects on nursing infants have been provided.

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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Additionally, healthcare professionals should consider contacting a poison control center for further guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

To ensure safety, the product must be kept out of the reach of children. Additionally, it is important to avoid using the product in conjunction with heating pads, as this may compromise its intended use or efficacy. Proper handling and storage are crucial for optimal performance.

Additional Clinical Information

The route of administration for the product is topical. There is no additional information available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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