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Auvon Pain Relief Roll-on

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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
83391-004
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 may find that this medication is designed to temporarily relieve minor pain. It works by targeting the discomfort you may experience, helping to make daily activities more manageable. If you're looking for a solution to ease minor aches, this drug could be a helpful option for you.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. Whether it's a headache, muscle ache, or discomfort from other minor injuries, you can use this medication to ease your symptoms. Remember, it's designed for short-term use to help you feel more comfortable.

Dosage and Administration

To use this medication effectively, you should apply a thin layer to the affected area of your skin every 6 to 8 hours. It's important to remember that you should not use it more than three times within a 24-hour period. This helps ensure that you get the best results while minimizing the risk of side effects. Always follow these guidelines to promote healing and comfort.

What to Avoid

You should avoid using this product if you are under 12 years of age unless you consult a doctor first. It's important not to use it if you are allergic to any of the ingredients listed on the package. Additionally, do not use the product if the packaging is damaged or opened, or if you are pregnant or breastfeeding.

Make sure to avoid using this product alongside other topical pain relievers, and do not apply it to your eyes, mucous membranes, or any areas of skin that are cut, wounded, damaged, swollen, or irritated. Following these guidelines will help ensure your safety while using this 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 without consulting a doctor, if you are 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. If your symptoms last more than 7 days or return after clearing up, seek medical advice. Lastly, if the product is ingested, seek medical help immediately.

Warnings and Precautions

It's important to use this product only as directed and for external use only. If you are under 12 years old, pregnant, breastfeeding, or allergic to any of the ingredients, please consult a doctor before use. Avoid using it on your eyes, mucous membranes, or any damaged or irritated skin. Do not use it alongside other topical pain relievers.

If your symptoms last more than 7 days, improve and then return within a few days, or if you notice any worsening of your skin condition—like redness, irritation, swelling, or blistering—stop using the product and contact your doctor.

In case of accidental ingestion, seek emergency medical help immediately. Always check the packaging to ensure it is intact before use.

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 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 information handy and be aware of the medications you are taking to prevent potential overdoses. Your safety is the top priority, so don’t wait to get help if you think you may have taken too much.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to avoid using this medication. The potential risks to your baby during pregnancy and while nursing are significant, and it is best to prioritize their safety. Always consult with your healthcare provider for guidance on safe treatment options during this time.

Lactation Use

If you are breastfeeding, it is important to know that this medication is not recommended for you. Using it while nursing could pose risks to your baby. Always consult with your healthcare provider for guidance on safe medications during breastfeeding to ensure the well-being of both you and your infant.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication on its own. Always consult with a doctor for guidance on the appropriate treatment options for younger children. Your healthcare provider can help determine the best course of action based on your child's specific needs.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 your treatment.

Always discuss any medications or treatments you are considering with your healthcare provider. They can help you understand potential interactions and ensure that your treatment plan is safe and effective for you.

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). This temperature range helps maintain its effectiveness and safety.

When handling the product, make sure to keep it in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and proper functioning.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours, but do not use it more than three times in a 24-hour period. This ensures you are using the medication safely and effectively. If you have any questions about your treatment, be sure to consult with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor pain.

How should I apply this drug?

You should apply a thin layer to the affected area every 6 to 8 hours, using it no more than three times in a 24-hour period.

Are there any age restrictions for using this drug?

Do not use this drug alone if you are under 12 years of age; please consult a doctor.

What should I do if I experience adverse reactions?

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

Can I use this drug if I am pregnant or breastfeeding?

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

What should I do if I accidentally ingest this drug?

If ingested, get medical help right away.

Where should I store this drug?

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

Are there any specific areas where I should not apply this drug?

Do not use it on eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin.

Can I use this drug with other topical analgesics?

No, do not use this drug at the same time as other topical analgesics.

Packaging Info

Below are the non-prescription pack sizes of Auvon Pain Relief Roll-on (lidocaine). 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

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain. It is suitable for use in patients experiencing discomfort due to various non-specific conditions.

Dosage and Administration

Healthcare professionals are advised to apply a thin layer of the medication to the affected area every 6 to 8 hours. The application should not exceed three times within a 24-hour period. Care should be taken to ensure that the area is clean and dry prior to application to optimize the effectiveness of the treatment.

Contraindications

Use of this product is contraindicated in the following situations:

Patients under 12 years of age should not use this product without consulting a doctor. Use is contraindicated in individuals with known allergies to any of the listed ingredients. The product should not be used if the packaging is damaged or opened, as this may compromise safety and efficacy.

Pregnant or breastfeeding individuals should avoid use due to potential risks to the fetus or infant. Concurrent use with other topical analgesics is contraindicated to prevent additive effects. Additionally, the product must not be applied to the eyes, mucous membranes, or any areas of the skin that are cut, wounded, damaged, broken, swollen, or irritated, as this may lead to adverse reactions.

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 product is intended for external use only.

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

  • In individuals under 12 years of age unless directed by a physician.

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

  • If the packaging is damaged or has been opened prior to use.

  • 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 consult a healthcare provider 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.

Emergency Situations In the event of ingestion, it is crucial to seek emergency medical assistance immediately.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product. It is important to read all directions and warnings carefully and to use the product only as directed, as it is intended for external use only.

In clinical practice, patients are advised not to use this product if they are under 12 years of age without consulting a doctor. Additionally, individuals with known allergies to any of the listed ingredients should refrain from use. The product should not be applied if the packaging is damaged or opened, or if the patient is pregnant or breastfeeding. Concurrent use with other topical analgesics is contraindicated. The product must not be applied to the eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin.

Patients should discontinue use and consult a doctor if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering, warrant immediate medical consultation.

In the event of ingestion, patients should seek medical help right away.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Auvon Pain Relief Roll-on (lidocaine). 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 alone. It is essential for caregivers to consult a healthcare professional for guidance regarding appropriate use in 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. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or infant health.

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 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 event of an overdosage, it is imperative to seek immediate medical assistance. 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 a consideration, it is advised to consult a healthcare professional prior to use. There are no specific non-teratogenic effects or detailed nonclinical toxicology findings 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 product out of reach of children and pets to prevent accidental ingestion. In the event of ingestion, patients should seek medical help immediately.

Patients under 12 years of age should be instructed not to use the product without consulting a doctor. Additionally, it is important to inform patients not to use the product if they are allergic to any of the listed ingredients. They should also be cautioned against using the product if the package is damaged or opened.

Pregnant or breastfeeding patients should be advised not to use the product. Furthermore, patients should be informed that the product should not be used concurrently with other topical analgesics.

Healthcare providers should emphasize that the product must not be applied to the eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin. Patients should be instructed to discontinue use and consult a doctor if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised to seek medical attention 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 ensures optimal handling and storage. It should be stored in a dry place at room temperature, specifically within the range of 20-25°C (68-77°F). Proper adherence to these storage conditions is essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply a thin layer of the medication to the affected area every 6 to 8 hours, ensuring that it is used no more than three times within a 24-hour period. 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.

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.