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Menthol Davis Analgesic

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This product has been discontinued

Active ingredient
Menthol 50 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
June 13, 2022
Active ingredient
Menthol 50 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
June 13, 2022
Manufacturer
Genia Care Phamaceutical S. A.
Registration number
part348
NDC root
82480-000

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be helpful if you're experiencing discomfort due to everyday activities or minor injuries. While the specific mechanism of action isn't detailed, its primary purpose is to alleviate pain, allowing you to feel more comfortable in your daily life.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It’s designed to help you feel more comfortable when dealing with these everyday discomforts.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects that could occur). This makes it a safe option for managing your minor pain.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid applying it to any wounds or damaged skin, as this can lead to complications. Additionally, be careful not to bandage the area tightly after application, as this may cause discomfort or hinder proper healing.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and do not apply it to any wounds or damaged skin. Additionally, refrain from tightly bandaging the area after application.

If your condition worsens, or if symptoms last longer than 7 days or return after improvement, you should stop using the product and consult a doctor. Always keep this product out of reach of children, and if it is swallowed, 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, wounds, or any damaged skin. It's also important not to wrap the area tightly after application to ensure proper healing.

If you notice that your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, if you accidentally swallow the product, seek medical help immediately or contact a Poison Control Center for assistance.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

There is currently no information available about the use of Menthol Davis Analgesic 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 regarding any medications you may consider during this time.

Lactation Use

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

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it 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 doctor before using the medication. This ensures that it is safe and appropriate for their age. Always prioritize your child's health by following these recommendations closely.

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 if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, discussing your full list of medications and any tests you undergo ensures that your healthcare provider can help you avoid potential issues and provide the best care tailored to your needs. Always feel free to ask questions and share your concerns during your appointments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry, and well-ventilated area. Keep it away from any sources of heat, ignition, or combustion, as these can pose risks. Proper storage is essential to maintain the integrity of the device and to prevent any potential hazards.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use, and dispose of any components according to local regulations to ensure safety and environmental protection.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

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.

How should adults and children over 2 years use this drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily.

What should I do if my child is under 2 years old?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this product?

You should avoid contact with the eyes, do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do if the condition worsens or symptoms persist?

You should stop use and ask a doctor if the condition worsens or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided in the drug insert.

Can nursing mothers use this drug?

The safety of this product during lactation has not been established, so caution should be exercised.

How should I store this drug?

Store it in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

What should I do if this drug is swallowed?

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

Packaging Info

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

Packaging configurations for Menthol Davis Analgesic.
Details

Drug Information (PDF)

This file contains official product information for Menthol Davis Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is identified by the code 51945-4 and is associated with the package labeling effective as of June 2, 2022. The principal display panel includes a visual representation, which is available in JPEG format. The labeling is designed to provide essential information regarding the product's use and characteristics.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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 application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

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

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. It is crucial to refrain from applying the product to wounds or damaged skin to prevent adverse reactions. Additionally, patients should be instructed not to bandage the area tightly after application, as this may lead to complications.

Patients must be informed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly after application.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

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 Menthol Davis Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthol Davis Analgesic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Menthol Davis Analgesic during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

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

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 this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand that they should 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.

When using this product, patients must be cautioned to avoid contact with the eyes. They should also be instructed not to apply the product to wounds or damaged skin, and to refrain from tightly bandaging the area where the product is applied. These precautions are essential to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored in a cool, dry, and well-ventilated area, away from any sources of heat, ignition, and combustion. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthol Davis Analgesic, 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 Menthol Davis Analgesic, 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.