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Auvon Pain Relief Roll-on

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Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Solution
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 2024
Label revision date
December 8, 2024
Manufacturer
SHENZHEN YUWEN E-COMMERCE CO. , LTD.
Registration number
M017
NDC root
83391-003
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 can use this medication for temporary relief from minor aches and pains associated with sore muscles and joints. It is designed to help alleviate discomfort, allowing you to feel more comfortable in your daily activities. If you're experiencing these types of pain, this drug may be a suitable option for you.

Uses

You can use this medication for the temporary relief of minor aches and pains in sore muscles and joints. Whether you've overexerted yourself at the gym or are dealing with everyday discomfort, this product can help ease your symptoms.

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

Dosage and Administration

To use this medication, you should apply a thin layer directly to the affected area of your skin. You can do this up to 3 to 4 times each day, depending on your needs. After applying the medication, it’s important to wash your hands thoroughly to avoid spreading the product to other areas or to other people. Following these steps will help ensure you get the best results from your treatment.

What to Avoid

It's important to be cautious when using this product. You should not use it if you are under 12 years of age without consulting a doctor, if you are allergic to any of the ingredients, or if the package is damaged or opened. Additionally, avoid using it while pregnant or breastfeeding, and do not apply it at the same time as other topical pain relievers.

Make sure to keep it away from your eyes, mucous membranes, and any cuts, wounds, or areas of skin that are damaged, broken, swollen, or irritated. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It is meant for external use only, and you should not use it if you are under 12 years old, allergic to any of the ingredients, or if the package is damaged. Additionally, avoid using it if you are pregnant or breastfeeding, or if you are using other topical pain relievers at the same time.

If you notice any worsening of your symptoms, such as increased redness, irritation, swelling, or blistering, you should stop using the product and consult a doctor. It's also important to discontinue use if your symptoms last more than 7 days or if they improve and then return shortly after. Always keep the product out of reach of children and pets, and seek medical help immediately if it is ingested.

Warnings and Precautions

It's important to use this product only as directed and for external use only. Please do not use it if you are under 12 years old, pregnant, or breastfeeding, or if you have allergies to any of the ingredients. Avoid using it on damaged or irritated skin, including cuts, wounds, or mucous membranes, and do not apply it alongside other topical pain relievers. If the package is damaged or opened, do not use it.

If your symptoms last more than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you notice any worsening of your condition, such as increased redness, irritation, swelling, or blistering, seek medical advice. Always keep this product out of reach of children, and if ingested, get emergency medical help immediately.

Overdose

If you suspect an overdose has occurred, it’s crucial to seek medical help immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms after taking a medication, don’t hesitate to contact emergency services or go to the nearest hospital.

Remember, acting quickly can make a significant difference in your health outcomes. Always keep emergency contact numbers handy and inform healthcare professionals about any medications you have taken. Your safety is the top priority, so don’t wait if you think an overdose has happened.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to avoid using this medication. The potential risks to your health and the health of your baby are significant, and it is best to consult with your healthcare provider for safer alternatives. Always prioritize your well-being and that of your child when considering any medication during this time.

Lactation Use

If you are breastfeeding, it is important to know that this medication should not be used during this time. There are potential risks associated with its use while nursing, and it is best to avoid it to ensure the safety of both you and your baby. Always consult with your healthcare provider for guidance on medications and breastfeeding to make informed decisions for your health and your child's well-being.

Pediatric Use

It’s important to know that this medication is not recommended for children under 12 years of age. If you have a child in this age group who may need treatment, please consult a doctor for guidance. They can provide you with the best options and ensure your child's safety. Always prioritize professional advice when it comes to your child's health.

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 before starting the medication. 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 should be used 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 be cautious when using this medication alongside other topical pain relievers (analgesics). Using them together can increase the risk of side effects or reduce the effectiveness of the treatments.

Always discuss any medications or treatments you are considering with your healthcare provider. They can help ensure that your treatment plan is safe and effective, taking into account all the medications you may be using.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at room temperature, ideally between 20-25°C (68-77°F). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should apply this medication topically by rubbing a thin film over the affected area. It is recommended to do this no more than 3 to 4 times a day. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.

FAQ

What is the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints.

How should I apply this drug?

You should rub a thin film over the affected area not more than 3 to 4 times daily and wash your hands after use.

Are there any contraindications for using this drug?

Yes, do not use this drug if you are under 12 years of age, allergic to the ingredients, pregnant, breastfeeding, or if the package is damaged.

What should I do if symptoms persist?

Discontinue use and consult a doctor if symptoms persist for more than 7 days or if you notice any signs of skin injury.

How should I store this drug?

Store it in a dry place at room temperature between 20-25°C (68-77°F) and away from direct sunlight.

What should I do if I accidentally ingest this drug?

Keep it out of reach of children and pets, and if ingested, get medical help right away.

Is this drug safe to use during pregnancy or breastfeeding?

No, do not use this drug if you are pregnant or breastfeeding.

Packaging Info

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

Packaging configurations for Auvon Pain Relief Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Auvon Pain Relief Roll-on, 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 available data.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to apply a thin film of the medication over the affected area. This application should not exceed 3 to 4 times daily. It is essential to wash hands thoroughly after each use to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients under 12 years of age should consult a doctor prior to use.

  • Individuals with known allergies to any of the listed ingredients should not use this product.

  • The product should not be used if the package is damaged or opened, as this may compromise safety and efficacy.

  • Use is contraindicated in pregnant or breastfeeding individuals due to potential risks to the fetus or infant.

  • Concurrent use with other topical analgesics is not recommended, as this may increase the risk of adverse effects.

  • Application on the eyes, mucous membranes, cuts, wounds, or on damaged, broken, swollen, or irritated skin is prohibited to prevent further irritation or injury.

Warnings and Precautions

Healthcare professionals are advised to adhere strictly to the following warnings and precautions when recommending or administering this product.

Usage Instructions It is imperative to read all directions and warnings thoroughly and to use the product only as directed. This formulation is intended for external use only.

Contraindications The product should not be used under the following circumstances:

  • In individuals under 12 years of age without prior consultation with a healthcare provider.

  • In patients with known allergies to any of the listed ingredients.

  • If the packaging is found to be damaged or opened upon receipt.

  • During pregnancy or while breastfeeding.

  • Concurrently with other topical analgesics.

  • On the eyes, mucous membranes, or on areas of the skin that are cut, wounded, damaged, broken, swollen, or irritated.

Discontinuation of Use Patients should discontinue use and seek medical advice if:

  • Symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

  • Any signs of deterioration or skin injury occur, including but not limited to redness, irritation, swelling, or blistering.

Child Safety This product must be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur, necessitating immediate discontinuation of use and consultation with a healthcare professional. Patients are advised to discontinue use and seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, any signs of deterioration or skin injury, including redness, irritation, swelling, or blistering, warrant prompt medical consultation.

Common adverse reactions may include local skin reactions. Patients should avoid using the product on eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin. The product is contraindicated for individuals under 12 years of age, those who are allergic to any of the listed ingredients, and for pregnant or breastfeeding individuals. It should not be used concurrently with other topical analgesics.

Patients are also advised to keep the product out of reach of children and pets. In the event of ingestion, immediate medical assistance should be sought.

Drug Interactions

Concurrent use of this medication with other topical analgesics is not recommended. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advisable to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimize treatment efficacy. Monitoring for any signs of increased local irritation or systemic effects is recommended if such combinations are inadvertently used.

Packaging & NDC

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

Packaging configurations for Auvon Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is essential for healthcare professionals to consult with a doctor regarding appropriate alternatives or treatments for this age group.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in lactating women is also unclear. Therefore, healthcare professionals are advised to counsel women of childbearing potential regarding the importance of effective contraception during treatment and to discuss alternative therapeutic options for pregnant or breastfeeding patients.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative that medical assistance is sought immediately. Prompt intervention is crucial to mitigate potential adverse effects associated with excessive intake.

Healthcare professionals should be vigilant for symptoms that may arise from an overdosage. While specific symptoms are not detailed in the provided information, it is essential to monitor the patient closely for any signs of distress or unusual reactions.

Management of an overdosage should follow established protocols. This includes assessing the patient's condition, providing supportive care, and implementing any necessary interventions as guided by clinical judgment and available resources. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

If pregnancy or breastfeeding is occurring, the use of this product is contraindicated due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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 and pets to prevent accidental ingestion. In the event of ingestion, patients should seek medical help immediately.

Patients should be informed that the medication is not recommended for individuals under 12 years of age without prior consultation with a healthcare professional. Additionally, it is crucial to ensure that patients do not use the medication if they have known allergies to any of the listed ingredients.

Healthcare providers should instruct patients to avoid using the medication if the package is damaged or opened, as this may compromise safety. Pregnant or breastfeeding patients should be cautioned against using the medication and should consult their healthcare provider for alternatives.

Patients should be made aware that the medication should not be used concurrently with other topical analgesics to prevent potential adverse effects. Furthermore, it should not be applied to the eyes, mucous membranes, cuts, wounds, or any areas of damaged, broken, swollen, or irritated skin.

Providers should emphasize the importance of discontinuing use and consulting a doctor if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised to stop using the medication and seek medical advice if they experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored in a dry place at room temperature, maintaining a temperature range of 20-25°C (68-77°F). It is essential to keep the product away from direct sunlight to ensure its integrity and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin film over the affected area not exceeding 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Auvon Pain Relief Roll-on, 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 Auvon Pain Relief Roll-on, 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.

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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.