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Flexilon

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Camphor (synthetic) 4 g/100 g
  • Menthol 7.5 g/100 g
  • Methyl Salicylate 10 g/100 g
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 2020
Label revision date
December 31, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 4 g/100 g
  • Menthol 7.5 g/100 g
  • Methyl Salicylate 10 g/100 g
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 2020
Label revision date
December 31, 2022
Manufacturer
Semprae Laboratories Inc
Registration number
part348
NDC root
72826-101
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 your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this drug may offer you some relief.

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, strains, bruises, and sprains.

This means that if you're dealing with discomfort from any of these issues, this medication may help alleviate your pain and improve your mobility. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years or older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's essential to consult a doctor before use. This will help ensure that the treatment is appropriate and safe for younger patients. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to use this product safely. You should avoid applying it to any wounds or areas of skin that are damaged, broken, or irritated, as this could lead to further complications. Additionally, do not use it in conjunction with a heating pad, as this may increase the risk of adverse effects. Always follow these guidelines to ensure your safety and the effectiveness of the product.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if you notice redness over the affected area, or if your symptoms persist for more than 7 days. Additionally, if your symptoms clear up and then return within a few days, or if you experience excessive skin irritation, it's important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek medical help or contact a Poison Center right away.

Be cautious to keep the product away from your eyes and mucous membranes, and do not wrap the area tightly with bandages. If you notice that your condition worsens, experience redness in the affected area, or if your symptoms last longer than 7 days or return shortly after improvement, stop using the product and call your doctor. Additionally, if you experience excessive skin irritation, it's important to reach out to your healthcare provider.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional advice if you think something might be wrong.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or precautions regarding the use of FLEXILON during pregnancy mentioned in the available information. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals or if there are any risks to the developing fetus.

Additionally, there are no dosage modifications or special precautions outlined for those who are pregnant. However, it's always best to consult with your healthcare provider before starting any new medication during pregnancy to ensure it is 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. However, the specific effects on nursing infants are not known. Always prioritize your health and your baby's well-being by discussing any medications or products with your healthcare provider.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply the medication to the affected area up to 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 or how your treatment should be managed.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective, especially if you have any liver concerns. They can help determine the best approach for your health needs.

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 remember that even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before purchasing, make sure the outer seal is intact; do not buy it if the seal is broken, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

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 aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

Who can use this drug?

Adults and children 12 years of age and older can apply it to the affected area not more than 3 to 4 times daily. Children under 12 years should consult a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned, but do not use it on wounds or damaged skin, and avoid using it with a heating pad.

What should I do if my condition worsens?

If your condition worsens, you experience redness over the affected area, or symptoms persist for more than 7 days, stop using the drug and consult a doctor.

Is this drug safe to use during pregnancy?

The insert does not mention any specific risks or contraindications regarding the use of this drug during pregnancy.

Can nursing mothers use this drug?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk and the effects on a nursing infant are not known.

What are the storage instructions for this drug?

Store the drug at 20-25°C (68-77°F) and do not purchase it if the outer seal is broken.

What should I do in case of accidental ingestion?

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

What precautions should I take while using this drug?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and use only as directed.

Packaging Info

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

Packaging configurations for Flexilon.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated for use on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to increased risk of adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes to prevent irritation or injury. Additionally, when applying the product, do not bandage the area tightly, as this may lead to adverse effects.

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

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, there is noticeable redness over the affected area, symptoms persist for more than seven days, symptoms resolve and then recur within a few days, or if excessive skin irritation develops. Monitoring for these signs is crucial to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if there is redness over the affected area, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, excessive skin irritation may occur, and in such cases, it is advised to seek medical advice.

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 Flexilon (methyl salicylate, menthol, camphor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Flexilon.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of FLEXILON during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of data when prescribing FLEXILON to women of childbearing potential and weigh the benefits against any potential risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 available information.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Although no specific symptoms are documented, vigilance is essential, as the clinical presentation may vary based on individual patient factors and the context of the overdose.

In the event of suspected overdosage, it is recommended that healthcare professionals initiate supportive care. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety. Consultation with a poison control center or a medical toxicologist may also be beneficial to guide further management and intervention strategies.

Given the lack of detailed information, it is crucial for healthcare providers to remain alert and prepared to address any complications that may arise from an overdose scenario.

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.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or on damaged, broken, or irritated skin to prevent further complications.

Patients should be informed that the product should not be used in conjunction with a heating pad, as this may lead to adverse effects. They should be counseled to discontinue use and consult a doctor if their condition worsens or if they notice redness over the affected area.

Additionally, patients should be made aware that if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, they should stop using the product and seek medical advice. They should also be cautioned to stop use and consult a healthcare professional if they experience excessive skin irritation.

While using the product, patients must be reminded to avoid contact with their eyes or mucous membranes. Furthermore, they should be advised against tightly bandaging the area where the product is applied to ensure proper safety and effectiveness.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the outer seal prior to purchase; the product should not be acquired if the outer seal is broken, as this may compromise the quality and safety of the product. Proper handling and storage conditions are crucial to ensure optimal performance and patient safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Flexilon, 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 Flexilon, 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.