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Exoten-C

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Active ingredients
  • Capsaicin 0.025 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 2017
Label revision date
October 16, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Capsaicin 0.025 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 2017
Label revision date
October 16, 2023
Manufacturer
Asclemed USA, Inc.
Registration number
M017
NDC root
76420-947
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

Exoten-C is a pain relief lotion designed to provide temporary relief from minor aches and pains in the muscles and joints. It is particularly useful for conditions such as arthritis, simple backache, sprains, bruises, and strains. This lotion can help soothe discomfort and support your mobility, making it a helpful option for managing everyday pain.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with conditions like arthritis, simple backaches, sprains, bruises, and strains.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

If you are an adult or a child who is at least two years old, 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.

What to Avoid

It's important to use this product safely. You should not apply it to wounds or any damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly after application, as this may cause irritation or other issues. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should be aware that this product is for external use only, so avoid getting it in your eyes. It’s important not to apply it to wounds or damaged skin, and you should not bandage the area tightly. If you are pregnant or breastfeeding, please consult your doctor before using this product.

If your symptoms last longer than seven days, stop using the product and talk to your physician. Additionally, keep it out of reach of children, and if it is swallowed, seek medical advice immediately.

Warnings and Precautions

This product is for external use only, so be sure to avoid getting it in your eyes. If you notice that your symptoms last longer than seven days, stop using the product and consult your doctor. It's important to keep this product out of reach of children; if it is swallowed, seek medical advice immediately.

Do not apply the product to any wounds or damaged skin, and avoid wrapping the area tightly with a bandage. If you are pregnant or breastfeeding, please contact your doctor before using this product to ensure it is safe for you.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should consult a physician immediately.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you suspect an overdose, seek medical help right away. Always prioritize safety and don't hesitate to reach out to a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to contact your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Consulting with your healthcare provider can help ensure that you and your baby remain safe and healthy while considering any potential risks associated with the medication. Always prioritize open communication with your physician regarding your health and breastfeeding.

Pediatric Use

When using this medication for children, you can apply it to the affected area three to four times a day if your child is two years old or older. However, if your child is under two years of age, it’s important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or share your concerns.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

No further information is available.

FAQ

What is Exoten-C?

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

What conditions does Exoten-C help with?

It is indicated for minor aches and pains associated with arthritis, simple backache, sprains, bruises, and strains.

How should I use Exoten-C?

Apply Exoten-C to the affected area not more than three to four times daily for adults and children two years of age or older. Consult a physician for children under two.

Are there any contraindications for Exoten-C?

No specific contraindications are mentioned, but do not apply to wounds or damaged skin.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, contact your physician prior to use.

What precautions should I take when using Exoten-C?

For external use only, avoid contact with eyes, and keep out of reach of children. If swallowed, consult a physician.

What should I do if symptoms persist?

If symptoms persist for more than seven days, discontinue use and consult your physician.

How should Exoten-C be stored?

Store Exoten-C at room temperature.

Packaging Info

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

Packaging configurations for Exoten-C.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Exoten-C is a pain relief lotion formulated for topical application. The product has a total weight of 113.4 grams and is distributed by Enovachem™ Pharmaceuticals, located in Torrance, California, with the contact number (310) 320-0100.

Uses and Indications

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

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 essential 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

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only; direct contact with the eyes should be avoided to prevent irritation or injury. In the event that symptoms persist beyond seven days, it is imperative to discontinue use and seek consultation with a physician to evaluate the condition further.

This product must be kept out of reach of children. In cases of accidental ingestion, immediate medical advice should be sought.

Application of this product is contraindicated on wounds or damaged skin. Additionally, it is advised not to apply a tight bandage over the treated area to ensure proper healing and to avoid exacerbating any potential adverse effects.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with their physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. The product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly after application.

In the context of pregnancy or breastfeeding, patients are encouraged to consult their physician prior to use. If symptoms persist for more than seven days, it is recommended that patients discontinue use and seek medical advice.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Exoten-C.
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 advised 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 contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers.

Renal Impairment

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

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 medication out of reach of children to prevent accidental ingestion. Should ingestion occur, it is crucial to consult a physician immediately for guidance on appropriate actions to take.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the specific medication involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers monitor the patient closely and provide interventions as necessary based on the clinical presentation.

In all cases of suspected overdosage, prompt medical attention is advised to ensure the safety and well-being of the patient.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should be instructed to consult a physician immediately.

Patients should be informed not to apply the medication to wounds or damaged skin. Additionally, they should be cautioned against bandaging the area tightly after application.

It is important for healthcare providers to instruct patients to discontinue use if symptoms persist for more than seven days and to seek medical advice in such cases.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Exoten-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 Exoten-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.

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.