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Zensezone Arthmed Temporary Pain Relief Cream

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Active ingredients
  • Capsaicin 0.25 mg/1 mL
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 150 mg/1 mL
Other brand names
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 2021
Label revision date
November 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Capsaicin 0.25 mg/1 mL
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 150 mg/1 mL
Other brand names
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 2021
Label revision date
November 11, 2023
Manufacturer
ZENSEZONE LLC
Registration number
M017
NDC root
82319-240
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 from minor aches and pains in muscles and joints. It can be particularly helpful for discomfort associated with conditions like arthritis, as well as injuries such as strains, bruises, and sprains.

If you're experiencing these types of pain, this drug may offer you some comfort and support in managing your symptoms. Always consult with a healthcare professional for personalized advice and treatment options.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. This includes discomfort associated with conditions like arthritis, as well as injuries such as strains, bruises, and sprains.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a suitable option for managing your pain without concerns about these specific risks.

Dosage and Administration

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

If your child is under two years old, it’s important to consult a physician (doctor) before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

You should avoid using this product on damaged or broken skin, as it can lead to further irritation or complications. If you notice any rash or irritation that lasts, or if your condition worsens or does not improve after 7 days, please stop using the product and consult a doctor.

While using this product, be careful to keep it out of your eyes; if contact occurs, rinse thoroughly with water. Additionally, do not apply a tight bandage over the area where the product is used, as this can cause issues. Always prioritize your safety and well-being when using any medication.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to damaged or broken skin. Avoid contact with your eyes; if this happens, rinse thoroughly with water. You should also refrain from tightly bandaging the area where the product is applied.

If you notice a rash or irritation that lasts, or if your condition worsens or does not improve after 7 days, stop using the product and consult a doctor. Keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center. If you are pregnant or breastfeeding, please consult a healthcare professional before use.

Warnings and Precautions

This product is for external use only and should not be ingested. Avoid applying it to damaged or broken skin, and be careful to keep it out of your eyes; if contact occurs, rinse your eyes with water immediately. When using the product, do not wrap the area tightly with a bandage.

If you notice a rash or irritation that lasts, or if your condition worsens or does not improve after 7 days, stop using the product and consult your doctor. It's important to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

When using this medication for children, it's important to follow specific guidelines. For children aged two years and older, you can apply it to the affected area up to three to four times a day. However, if your child is under two years old, you should consult a physician (doctor) before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 health situation. They can help determine the best course of action based on your kidney function and overall health.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, it's important to store it properly. Keep the product in its container and protect it from excessive heat and direct sunlight, as these conditions can damage it.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You can apply this medication to the affected area three to four times a day if you are an adult or a child aged two years and older. If your child is under two years old, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.

How should I apply the drug?

Adults and children two years of age and older should apply it to the affected area not more than three to four times daily. For children under two years of age, consult a physician.

Are there any contraindications for using this drug?

You should not use this drug on damaged or broken skin.

What should I do if I experience a rash or irritation?

Stop use and ask a doctor if a rash or irritation develops and lasts, or if your condition worsens or symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if the drug is swallowed?

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

What precautions should I take when using this product?

Keep the product out of your eyes and rinse with water if contact occurs. Do not bandage tightly.

Is this drug intended for ingestion?

No, this drug is for external use only and is not intended for ingestion.

Packaging Info

Below are the non-prescription pack sizes of Zensezone Arthmed Temporary Pain Relief Cream (capsaicin, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Zensezone Arthmed Temporary Pain Relief Cream.
Details

Drug Information (PDF)

This file contains official product information for Zensezone Arthmed Temporary Pain Relief Cream, 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 and is supplied in a bottle.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints, including those associated with arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use of this product is contraindicated in patients with damaged or broken skin. Due to the potential for exacerbation of the condition, application should be avoided in these circumstances. Additionally, if a rash or irritation develops and persists, or if the condition worsens or symptoms recur within a few days after initial improvement, discontinuation and consultation with a healthcare professional are advised.

Warnings and Precautions

The product is intended solely for external use and is not suitable for ingestion. It is imperative that the product is not applied to damaged or broken skin to prevent adverse reactions.

When utilizing this product, care must be taken to avoid contact with the eyes. In the event of contact, the eyes should be rinsed thoroughly with water to remove any residue. Additionally, it is advised not to apply a tight bandage over the area of application, as this may lead to complications.

Users should discontinue use and consult a healthcare professional if a rash or irritation develops and persists, if the condition worsens, or if symptoms continue for more than seven days or reappear shortly after resolution.

To ensure safety, the 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 recommended.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be ingested. It is contraindicated for application on damaged or broken skin.

During use, patients should take care to avoid contact with the eyes; in the event of contact, the eyes should be rinsed with water immediately. Additionally, it is advised not to bandage the area tightly after application.

Patients are instructed to discontinue use and consult a healthcare professional if a rash or irritation develops and persists, if the condition worsens, or if symptoms last longer than 7 days or recur shortly after resolution.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

For pregnant or breastfeeding individuals, it is essential to seek advice from a healthcare professional prior to use.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Zensezone Arthmed Temporary Pain Relief Cream (capsaicin, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Zensezone Arthmed Temporary Pain Relief Cream.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is recommended to consult a physician 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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to damaged or broken skin to avoid potential complications.

Healthcare providers should instruct patients to discontinue use and consult a doctor if a rash or irritation develops and persists. Additionally, patients should be made aware that they should stop using the product and seek medical advice if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using the product, patients must be cautioned to keep it out of their eyes and to rinse with water immediately if contact occurs. Lastly, it is essential to inform patients not to bandage the area tightly after application to ensure proper healing and avoid further irritation.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

For patients aged two years and older, the medication should be applied to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Zensezone Arthmed Temporary Pain Relief Cream, 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 Zensezone Arthmed Temporary Pain Relief Cream, 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.