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Healthwise Cold Therapy Menthol Pain Relief

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Active ingredient
Menthol 10.5 mg/1 mL
Other brand names
Dosage form
Spray
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 13, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 10.5 mg/1 mL
Other brand names
Dosage form
Spray
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 13, 2026
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-985
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

You may find this medication helpful for the temporary relief of minor pain. It is commonly associated with conditions such as arthritis, simple backache, strains, sprains, and bruises. This means that if you're dealing with any of these issues, this drug could provide you with some comfort and ease your discomfort.

Uses

If you're dealing with minor pain from conditions like arthritis, simple backaches, strains, sprains, or bruises, this medication can provide temporary relief. It's designed to help ease discomfort so you can go about your daily activities more comfortably.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years or older, you can apply this medication to the affected area up to 3 to 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

It's important to use this medication safely. You should not apply it to any wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly after application, as this may interfere with the medication's effectiveness and could cause discomfort. Always follow these guidelines to ensure your safety and the best possible results.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety precautions. You should avoid contact with your eyes and refrain from applying it to wounds or damaged skin. If your condition worsens, or if symptoms last more than seven days or return after clearing up, stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Remember, this product is for external use only and is flammable, so avoid using it near heat or flames.

Warnings and Precautions

This product is for external use only and is flammable, so please avoid using it while smoking or near any heat sources or flames. Remember not to puncture or incinerate the container, as it is under pressure.

When using this product, be careful to avoid contact with your eyes, and do not apply it to any wounds or damaged skin. It's also important not to wrap the area tightly with a bandage. If your condition worsens, or if symptoms last more than 7 days or improve and then come back within a few days, stop using the product and call your doctor.

If you accidentally swallow this product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. Before using it, you should consult your doctor to discuss any potential risks. Currently, there are no specific studies on how menthol may affect fetal development, so caution is advised.

If you decide to use this product, do so only if it is clearly necessary and after having a thorough discussion with your healthcare provider about the possible risks involved. There are no specific dosage adjustments recommended for pregnant individuals, but your doctor can help guide you on the best course of action.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make 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

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 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 should be used if you have renal impairment (kidney issues).

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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, and well-ventilated area, away from direct sunlight. It's important to keep the temperature below 120°F (49°C) to maintain its integrity.

When handling the product, always ensure that your hands and any surfaces are clean to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of minor pain associated with conditions like arthritis, simple backache, strains, sprains, and bruises.

How should I apply this drug?

For adults and children 2 years or older, apply to the affected area no more than 3 to 4 times daily. Do not use on children under 2 years of age without consulting a doctor.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but you should consult a doctor if you are pregnant or planning to become pregnant.

What precautions should I take when using this drug?

Avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. This product is for external use only and is flammable.

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 reoccur within a few days.

What should I do if this drug is swallowed?

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so use only if clearly needed and after discussing potential risks with a healthcare provider.

How should I store this drug?

Store the drug out of direct sunlight, in a cool, dry, well-ventilated area, and do not store it at temperatures above 120°F (49°C).

Packaging Info

Below are the non-prescription pack sizes of Healthwise Cold Therapy Menthol Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Healthwise Cold Therapy Menthol Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Healthwise Cold Therapy Menthol Pain 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 temporary relief of minor pain associated with various conditions, including arthritis, simple backache, strains, sprains, and bruises.

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

Dosage and Administration

For adults and children aged 2 years or 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 unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it should not be used with tight bandaging, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or flame. Users must avoid puncturing or incinerating the container, as it is under pressure.

When utilizing this product, it is crucial to avoid contact with the eyes. Application should not occur on wounds or damaged skin, and users are advised against tightly bandaging the area of application.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. Additionally, the product should not be punctured or incinerated, as it contains contents under pressure.

When using this product, patients are advised to avoid contact with the eyes and to refrain from applying it to wounds or damaged skin. It is also recommended that the product not be bandaged tightly.

Patients should 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 reoccur within a few days.

Furthermore, 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 at 1-800-222-1222.

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 Healthwise Cold Therapy Menthol Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Healthwise Cold Therapy Menthol Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; caregivers are advised to consult a physician for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no specific studies available regarding the effects of menthol on fetal development, and therefore, the potential risk to the fetus remains unclear. No specific dosage modifications are provided for pregnant individuals. It is recommended that this product be used only if clearly needed and after a thorough discussion of potential risks with a healthcare provider.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 safety profile in nonclinical settings.

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 at 1-800-222-1222 if the product is swallowed. It is important for patients to understand that they should 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 reoccur within a few days.

When using this product, patients should be instructed to avoid contact with the eyes. They should also be cautioned against applying the product to wounds or damaged skin, and they should not bandage the area tightly. These precautions are essential to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product out of direct sunlight, in a cool, dry, and well-ventilated area. The storage temperature must not exceed 120°F (49°C) to ensure the integrity and efficacy of the product. Special handling precautions should be observed to maintain optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Healthwise Cold Therapy Menthol Pain 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 Healthwise Cold Therapy Menthol Pain 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.