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Nvcare

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This product has been discontinued

Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
March 8, 2023
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
Marketed in the U.S.
Since 2023
Label revision date
March 8, 2023
Manufacturer
SOMBRA COSMETICS INC.
Registration number
part348
NDC root
61577-5320

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be particularly helpful for common issues such as simple backaches, strains, bruises, and sprains. If you're experiencing discomfort from these types of injuries, this drug may provide the relief you need.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort related to simple backaches, strains, bruises, and sprains. Whether you've overexerted yourself during physical activity or just need a little help managing everyday aches, this medication is designed to ease your pain and help you feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the gel to the affected area of your skin. Make sure to do this no more than 3 to 4 times a day. After applying, rub the gel in thoroughly until it is fully absorbed into your skin.

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

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it.

However, it's always important to consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to wounds or damaged skin. You should avoid tightly bandaging the area and keep the product away from your eyes. Additionally, make sure to store it out of reach of children.

If you notice that your condition worsens, if 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.

Warnings and Precautions

This product is intended for external use only, so please do not apply it to wounds or damaged skin. While using it, be careful to avoid tightly bandaging the area and keep it away from your eyes. It's also important to store this product out of reach of children to ensure their safety.

If you notice that your condition worsens, if 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, 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

There is currently no information available about the use of NVCARE 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.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. This product is meant for external use only, so avoid applying it to wounds or damaged skin. When using it, make sure not to bandage the area tightly and keep it away from the eyes.

For children aged 2 years and older, you can apply the product to the affected area up to 3 to 4 times a day, rubbing it in thoroughly until it is absorbed. However, if your child is under 2 years old, you should consult a doctor before use.

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 considering this medication, it’s important to consult with a healthcare provider. 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 is safe and effective for your specific condition. 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 should be used if you have hepatic impairment (liver issues).

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 determine the best course of action based on your individual situation.

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 interactions with other drugs or laboratory tests. However, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

Remember, even if no interactions are currently noted, your health can change, and new information may arise. Regular discussions with your provider can help you stay informed and safe.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature in a cool, dry place. It's important to keep the container tightly closed to prevent contamination and protect it from excessive heat, which can affect its quality. Avoid freezing the product, as this can damage it.

Once you open the container, be sure to discard any unused product to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. Make sure to rub it in thoroughly until the gel is fully absorbed. If you are using it for a child under 2 years old, it's important to consult a doctor first for guidance.

FAQ

What does this drug relieve?

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

How should I use 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 and rub in thoroughly until the gel is absorbed. Consult a doctor for children under 2 years of age.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, avoid bandaging tightly, and keep it out of reach of children.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing mothers.

How should I store this drug?

Store at room temperature, keep the container tightly closed, protect from excessive heat, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Nvcare.
Details

Drug Information (PDF)

This file contains official product information for Nvcare, 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 specific description details are provided in the text.

Uses and Indications

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

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 rubbed in thoroughly 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 deemed safe for use in the general population without specific restrictions or conditions that would preclude its administration.

Warnings and Precautions

This product is intended for external use only and should not be applied to wounds or damaged skin. Healthcare professionals should advise patients to avoid tightly bandaging the area where the product is applied, as this may lead to adverse effects. Additionally, it is crucial to prevent contact with the eyes to avoid irritation or injury.

To ensure safety, this product must be kept out of reach of children. Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if the symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure appropriate management and to prevent complications.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. When using this product, it is important to avoid bandaging tightly and to prevent contact with the eyes. Additionally, the product should be kept out of reach of children.

In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Nvcare.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. It is intended for external use only and should not be applied to wounds or damaged skin. When using this product, caregivers must avoid bandaging tightly and ensure that it does not come into contact with the eyes.

For dosing, the product is indicated for use in adults and children aged 2 years and older, with a recommended application of 3 to 4 times daily to the affected area, ensuring thorough rubbing in until the gel is absorbed. For children under 2 years of age, consultation with a doctor 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 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 NVCARE menthol gel during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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

Overall, vigilance and prompt intervention are key components in managing any suspected overdose situation.

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. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients 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 container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from excessive heat, and must not be frozen. After opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. Patients should rub the gel into the affected area thoroughly until it is fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Nvcare, 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 Nvcare, 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.