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Vonaflex Effective Pain Relief Topical Analgesic

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 28, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2025
Label revision date
January 28, 2026
Manufacturer
OPTIMAL LABORATORIES, LLC
Registration number
M017
NDC root
87359-987
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to provide temporary relief of pain. It works by targeting the underlying causes of discomfort, helping you feel more comfortable in your daily activities. If you're experiencing pain, this medication may be a suitable option to consider for short-term relief. Always consult with a healthcare professional to ensure it's the right choice for your needs.

Uses

You can use this medication for the temporary relief of pain. Whether you're dealing with a headache, muscle ache, or other types of discomfort, this drug can help ease your symptoms for a short period. Always remember that while it can provide relief, it's important to address the underlying cause of your pain with a healthcare professional if it persists.

Dosage and Administration

If you or your child is 2 years old or older, you can apply a thin layer of the lotion to the affected area. Make sure to massage it in until the lotion is no longer visible. You can do this up to three times a day for the best results.

If your child is under 2 years of age, it's important to consult a doctor before using the lotion. They can provide guidance on the appropriate treatment for younger children.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in large amounts, especially on raw or blistered skin, and be careful to keep it away from your eyes. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. While using this product, be careful not to let it come into contact with your eyes.

If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and consult your doctor. Keep this product out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product.

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 seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is 2 years old or older, you can apply a thin layer of the lotion to the affected area and gently massage it in until it disappears. You can do this up to three times a day. However, if your child is under 2 years old, it's important to consult a doctor before using the lotion to ensure it's safe for them. Always prioritize your child's health and follow these guidelines for their age group.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it protected from moisture, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply a thin layer of the lotion to the affected area and gently massage it in until it is no longer visible. This can be done up to three times a day. If you are caring for a child under 2 years old, it's important to consult a doctor before use.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain.

How should I apply the lotion?

For adults and children 2 years of age and older, apply a thin layer to the affected area and massage until the lotion is no longer visible, up to three times a day.

What should I do if I have a child under 2 years of age?

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

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with the eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens?

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

What should I do if the lotion is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

If you are pregnant or breastfeeding, ask a health professional before use.

What is the recommended storage condition for this drug?

Store at 20-25°C (68-77°F) and protect from moisture.

Packaging Info

Below are the non-prescription pack sizes of Vonaflex Effective Pain Relief Topical Analgesic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vonaflex Effective Pain Relief Topical Analgesic.
Details

Drug Information (PDF)

This file contains official product information for Vonaflex Effective Pain Relief Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain. It is intended for use in patients experiencing acute pain conditions. Healthcare professionals should assess the appropriateness of this treatment based on individual patient needs and the specific pain management requirements.

Dosage and Administration

For adults and children aged 2 years and older, a thin layer of the lotion should be applied to the affected area. The application should be massaged gently until the lotion is no longer visible. This process may be repeated up to three times a day, as needed.

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

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, particularly on raw surfaces or blistered areas, to prevent adverse effects.

When using this product, it is imperative to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, the user should discontinue use and consult a healthcare professional.

This product must be kept out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects.

During use, patients should take care to avoid contact with the eyes. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use to ensure safety.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Vonaflex Effective Pain Relief Topical Analgesic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vonaflex Effective Pain Relief Topical Analgesic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin layer of the lotion to the affected area, massaging until the lotion is no longer visible, up to three 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) and must be protected from moisture to maintain its integrity. Proper handling is essential to ensure the product remains effective and safe for use.

Additional Clinical Information

For patients aged 2 years and older, the recommended administration involves applying a thin layer of the lotion to the affected area and massaging until the lotion is no longer visible, with a maximum frequency of three times per day. For children under 2 years of age, it is advised to consult a doctor prior to use.

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

Drug Information (PDF)

This file contains official product information for Vonaflex Effective Pain Relief Topical 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 Vonaflex Effective Pain Relief Topical 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

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.