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Benova Pain and Itch Relief

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Active ingredient
Menthol 1.1 mg/1 mL
Other brand names
Dosage form
Lotion
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
October 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 1.1 mg/1 mL
Other brand names
Dosage form
Lotion
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
October 29, 2025
Manufacturer
BENOVA RX LLC
Registration number
M017
NDC root
87150-001
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

Benova® is a pain and itch relief lotion designed to provide immediate relief for discomfort associated with various skin irritations. This lotion is steroid-free, making it a gentle option for sensitive skin, and it can be used by adults and children aged 2 years and older. You can apply it to the affected area up to three or four times daily to help soothe your skin.

Uses

You can use this medication for treating affected areas on adults and children who are 2 years old and older. It's important to apply it no more than 3 or 4 times a day. However, if your child is under 2 years of age, you should consult a doctor before using it.

This medication has not been reported to cause any teratogenic effects (which means it doesn't harm the developing fetus) or nonteratogenic effects. Always follow your healthcare provider's advice for the best results.

Dosage and Administration

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

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

You should only use this product externally and avoid any contact with your eyes. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. It's important to follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to be aware of some warnings associated with this product. It is for external use only, so you should avoid getting it in your eyes. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult a doctor. Additionally, keep it 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 near your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor.

It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please take these precautions seriously.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication or product to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource to ensure that the medication is safe and appropriate for your individual health needs. Always keep them informed about any other medications or health conditions to help manage your care effectively.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from excessive heat and direct sunlight. This will help maintain its effectiveness. Always check the seal before use; if the seal is broken, do not use the product, as this could compromise its safety and efficacy.

By following these simple guidelines, you can help ensure that your product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 or 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, consult a doctor before use. It's important to keep this medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center right away.

FAQ

What is Benova®?

Benova® is a pain and itch relief lotion designed for immediate relief.

Who can use Benova®?

Adults and children 2 years of age and older can use Benova®. Children under 2 years should not use it and should consult a doctor.

How should I apply Benova®?

Apply Benova® to the affected area not more than 3 or 4 times daily.

Are there any warnings for using Benova®?

Yes, it is for external use only, avoid contact with eyes, and stop use if the condition worsens or symptoms persist for more than 7 days.

What should I do if I swallow Benova®?

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

Is Benova® safe to use during pregnancy?

There is no specific information regarding the use of Benova® during pregnancy, so consult a doctor before use.

Can nursing mothers use Benova®?

Nursing mothers should consult a doctor before using Benova® as it may be excreted in breast milk.

What should I do if the seal on Benova® is broken?

Do not use Benova® if the seal is broken.

What is the volume of Benova®?

Benova® comes in a volume of 3 FL OZ (90 mL).

Packaging Info

Below are the non-prescription pack sizes of Benova Pain and Itch Relief (menthol, 0.11%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Benova Pain and Itch Relief.
Details

Drug Information (PDF)

This file contains official product information for Benova Pain and Itch Relief, 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 drug.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It should be applied no more than 3 to 4 times daily.

For children under 2 years of age, the use of this drug is not recommended; consultation with a healthcare professional is advised prior to use.

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 is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to ensure safety and appropriateness for this age group.

Contraindications

The product is contraindicated for external use only. Contact with the eyes should be avoided. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, discontinue use and consult a healthcare professional.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than 7 days, it is recommended to discontinue use of this product and consult a healthcare professional. Should symptoms resolve and then recur within a few days, the use of this product should also be stopped, and medical advice should be sought.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, it is recommended to stop using the product and seek medical advice.

It is crucial to keep this product out of reach of children. In cases where the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. These precautions are essential to ensure the safety and well-being of patients using the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Benova Pain and Itch Relief (menthol, 0.11%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Benova Pain and Itch Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3 or 4 times daily.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

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

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to emphasize that the product is for external use only. Patients should be cautioned to avoid contact with the eyes, as this may lead to irritation or other adverse effects.

Additionally, healthcare providers should inform patients to stop using the product 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. This guidance is crucial to ensure patient safety and effective management of their condition.

Storage and Handling

This product is supplied in a configuration that ensures optimal integrity and efficacy. It is essential to protect the product from excessive heat and direct sunlight to maintain its quality. Additionally, the product should not be used if the seal is broken, as this may compromise its safety and effectiveness. Proper handling and storage conditions are crucial for preserving the product's intended use.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Benova Pain and Itch Relief, 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 Benova Pain and Itch Relief, 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.