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Xoten-C

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This product has been discontinued

Active ingredients
  • Capsaicin 0.002 g/100 g
  • Menthol 10 g/100 g
  • Methyl Salicylate 20 g/100 g
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 2011
Label revision date
July 26, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Capsaicin 0.002 g/100 g
  • Menthol 10 g/100 g
  • Methyl Salicylate 20 g/100 g
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 2011
Label revision date
July 26, 2011
Manufacturer
Living Well Pharmacy Inc.
Registration number
part348
NDC root
64038-944
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

XOTEN-C is a pain relief lotion designed to help you find temporary relief from minor aches and pains in your muscles and joints. It can be particularly beneficial for conditions such as simple backache, arthritis, sprains, strains, and bruises. The lotion works by alleviating muscle pain and reducing swelling, making it a supportive option for managing discomfort in everyday activities.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, sprains, strains, and bruises. This means if you're experiencing discomfort from any of these issues, this medication may help alleviate your pain and improve your comfort.

It's important to note that there are no reported 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

It's important to use this medication only as directed. After applying the lotion, make sure to wash your hands thoroughly to prevent it from getting into your eyes or other sensitive areas. If you're applying the lotion to your hands, wait at least 30 minutes before washing them to ensure the medication has time to work.

For adults and children aged 12 years and older, you can apply the lotion to the affected area up to 3 to 4 times a day. However, if the person is under 12 years old, it's best to consult a doctor before use. Always follow these guidelines to ensure safe and effective treatment.

What to Avoid

It's important to use this product safely to avoid any complications. You should never apply it on wounds, damaged, broken, or irritated skin. Additionally, avoid using it with a heating pad or immediately before or after bathing or showering.

While using this product, make sure to keep it away from your lips, eyes, nose, and any mucous membranes, as contact can cause irritation. Also, do not bandage the area tightly, as this can lead to further issues. Always follow these guidelines to ensure your safety and well-being.

Side Effects

When using this product, it's important to be aware of certain side effects and precautions. You should only apply it to unbroken skin and avoid using it on wounds or irritated areas. If your condition worsens, if symptoms last more than seven days, or if you experience skin irritation, stop using the product and consult a doctor. Additionally, avoid contact with your lips, eyes, nose, and any mucous membranes, and do not apply tight bandages over the area.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, damaged, broken, or irritated skin. It's also important not to use it with a heating pad or immediately before or after bathing or showering.

If you notice that your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience any skin irritation, it's best to seek medical advice. In case of accidental swallowing, please get medical help or contact the Poison Control Center immediately.

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 your local 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 reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns provided. It's important to consult with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that it is generally considered safe for you to use without concerns about it affecting your breast milk or posing risks to your infant.

However, as with any medication or product, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about its use during breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without first consulting a doctor. For those aged 12 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 the safety and effectiveness of the treatment for your child.

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 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 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 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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all the medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best use of the product, store it at room temperature. After using the lotion, it's important to wash your hands thoroughly to prevent any accidental contact with your eyes or other sensitive areas. If you apply the lotion to your hands, please wait at least 30 minutes before washing them to allow the product to absorb properly. Remember to discard the lotion after opening to maintain safety and effectiveness.

Additional Information

You should apply the lotion topically to the affected area, using it no more than 3-4 times daily if you are an adult or a child aged 12 years and older. If the user is under 12 years old, it's important to consult a doctor before use.

After applying the lotion, make sure to wash your hands thoroughly to prevent it from getting into your eyes or other sensitive areas. If you apply the lotion to your hands, wait at least 30 minutes before washing them to ensure the product has time to work effectively.

FAQ

What is XOTEN-C?

XOTEN-C is a pain relief lotion designed for the temporary relief of minor aches and pains of muscles and joints.

What conditions can XOTEN-C help relieve?

XOTEN-C is beneficial for relieving muscle pain and swelling associated with simple backache, arthritis, sprains, strains, and bruises.

How should I use XOTEN-C?

Apply XOTEN-C to the affected area not more than 3-4 times daily for adults and children 12 years of age and older. Children under 12 should consult a doctor before use.

Are there any precautions I should take when using XOTEN-C?

Yes, avoid using XOTEN-C on wounds, damaged skin, or with a heating pad. Also, do not use it immediately before or after bathing.

What should I do if I experience skin irritation while using XOTEN-C?

If skin irritation occurs or if your condition worsens, stop using the product and consult a doctor.

Can I use XOTEN-C if I am pregnant or nursing?

The provided information does not mention any specific warnings regarding the use of XOTEN-C during pregnancy or nursing. Consult your doctor for personalized advice.

What should I do if XOTEN-C is swallowed?

If swallowed, seek medical help or contact the Poison Control Center immediately.

How should I store XOTEN-C?

Store XOTEN-C at room temperature and wash your hands thoroughly after use to avoid spreading the lotion to sensitive areas.

Packaging Info

Below are the non-prescription pack sizes of Xoten-C (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Xoten-C.
Details

Drug Information (PDF)

This file contains official product information for Xoten-C, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

XOTEN-C is a pain relief lotion formulated to alleviate muscle pain and reduce swelling. It is manufactured in a net weight of 4 ounces (113.4 grams) by MedChem Manufacturing, located in Torrance, California 90501.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, sprains, strains, and bruises.

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

Dosage and Administration

The medication should be used only as directed. Healthcare professionals are advised to instruct patients to wash their hands thoroughly after application to prevent the lotion from coming into contact with the eyes or other sensitive areas of the body.

For patients applying the lotion to their hands, it is recommended to wait at least 30 minutes before washing their hands to ensure adequate absorption.

For adults and children aged 12 years and older, the lotion should be applied to the affected area no more than 3 to 4 times daily. The use of this medication is not recommended for children under 12 years of age; in such cases, consultation with a healthcare provider is necessary.

Contraindications

The product is contraindicated for use on wounds, damaged, broken, or irritated skin due to the potential for exacerbating these conditions. Application with a heating pad is also contraindicated, as it may increase the risk of adverse effects. Additionally, the product should not be applied immediately before or after bathing or showering, as this may interfere with its efficacy and safety.

During use, it is essential to avoid contact with the lips, eyes, nose, and any mucous membranes to prevent irritation or injury. Furthermore, tight bandaging of the area where the product is applied is contraindicated, as it may lead to complications.

Warnings and Precautions

For external use only. This product should not be applied to wounds, damaged, broken, or irritated skin. It is contraindicated for use in conjunction with a heating pad and should not be applied immediately before or after bathing or showering.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if skin irritation develops, patients should stop using the product and consult a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important safety considerations. This product is intended for external use only and should not be applied to wounds, damaged, broken, or irritated skin. It is also contraindicated for use with a heating pad and should not be applied immediately before or after bathing or showering.

Participants are advised to discontinue use and consult a healthcare professional 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, if skin irritation occurs, it is recommended to stop use and seek medical advice.

While using this product, it is crucial to avoid contact with the lips, eyes, nose, and any mucous membranes at all times. Bandaging should not be done tightly over the area of application.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Xoten-C (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Xoten-C.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents aged 12 years and older, the recommended application is to the affected area not more than 3-4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is recommended that healthcare providers remain vigilant and informed about any emerging data related to the use of this medication in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no known concerns related to the potential for excretion in breast milk or associated risks for breastfed infants.

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. Healthcare professionals are advised to seek medical help or contact the Poison Control Center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact the Poison Control Center immediately.

Patients should be informed that this product is not intended for use on wounds, damaged, broken, or irritated skin. Additionally, it should not be used in conjunction with a heating pad, nor should it be applied immediately before or after bathing or showering.

Healthcare providers should instruct patients 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. Patients should also be advised to stop using the product and seek medical advice if they experience any skin irritation.

While using this product, patients must avoid contact with the lips, eyes, nose, and any mucous membranes at all times. Furthermore, they should be cautioned against bandaging the area tightly when applying the product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and safety.

Healthcare professionals should ensure that hands are washed thoroughly after use to prevent the inadvertent transfer of the lotion to the eyes or other sensitive areas of the body. In cases where the lotion is applied to the hands, it is advised to wait at least 30 minutes before washing hands to allow for optimal absorption.

Additionally, the product should be discarded after opening to ensure safety and prevent contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3-4 times daily for adults and children aged 12 years and older. For children under 12 years, use is not advised without consulting a healthcare professional.

Clinicians should counsel patients to wash their hands thoroughly after application to prevent the lotion from contacting the eyes or other sensitive areas. If the lotion is applied to the hands, patients are advised to wait 30 minutes before washing their hands to ensure optimal efficacy. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Xoten-C, 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 Xoten-C, 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.

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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.