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Bioflexor

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This product has been discontinued

Active ingredient
Menthol 3 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1998
Label revision date
December 12, 2023
Active ingredient
Menthol 3 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1998
Label revision date
December 12, 2023
Manufacturer
Health Care Laboratories Inc.
Registration number
M017
NDC root
62391-100

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If you are a consumer or patient please visit this version.

Drug Overview

Bioflexor is a medication designed to temporarily relieve minor aches and pains in muscles and joints. It is commonly used for conditions such as simple backache, arthritis, strains, bruises, and sprains. By targeting these discomforts, Bioflexor helps you manage everyday pain and maintain your mobility.

Uses

You can use this medication to temporarily relieve 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 if you're dealing with discomfort from any of these issues, this medication may help ease 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, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 12 years of age, it’s important to consult a doctor before use. This will help ensure that the treatment is safe and appropriate for their specific needs. Always follow your healthcare provider's advice for the best care.

What to Avoid

It's important to use this product safely to avoid potential complications. You should not use it on wounds or damaged skin, with a heating pad, or on children under 12 years of age who have arthritis-like conditions.

While using this product, make sure to avoid contact with your eyes or mucous membranes, and do not apply a tight bandage. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, if they clear up and then return within a few days, or if you experience excessive skin irritation. Additionally, if you notice any redness over the affected area, it's advisable to ask a doctor before continuing use.

Remember, this product is for external use only, and you should keep it out of reach of children. If swallowed, seek medical help or contact the Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that may be ingested. Keep it out of reach of children, and if it is swallowed, seek medical help or contact the Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens or if symptoms last longer than 7 days. Additionally, if your symptoms improve and then return within a few days, or if you experience excessive skin irritation, it’s important to reach out to your healthcare provider for further guidance.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact the Poison Control Center.

Signs of an overdose can vary, but if you suspect that someone has taken too much, it's crucial to act quickly. Always prioritize safety and don't hesitate to reach out for professional assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of BioFlexor menthol gel during pregnancy has not been established. There may be potential risks to your fetus, so it's crucial to approach the use of this product with caution. Always consult your doctor before using it to ensure it is safe for your specific situation.

Currently, there are no specific dosage modifications provided for pregnant individuals. Therefore, it's best to seek guidance from a healthcare professional regarding its use during pregnancy. Your health and the health of your baby should always come first.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. This is especially crucial if your child has any arthritis-like conditions, as the medication should not be used in these cases. Always prioritize your child's health by seeking professional advice to ensure their 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 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have kidney issues, it's important to consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help ensure your treatment is safe and effective based on your individual health needs.

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 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 monitor your condition and make any necessary adjustments to your treatment plan.

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, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 15º-30ºC (59º-86ºF). This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to do so with clean hands or gloves to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of the product once it is no longer needed.

Additional Information

For adults and children aged 12 and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Bioflexor used for?

Bioflexor is used to temporarily relieve minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

How should I use Bioflexor?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 should consult a doctor.

Are there any warnings for using Bioflexor?

Bioflexor is for external use only. Avoid contact with eyes or mucous membranes, and do not bandage tightly.

What should I do if I experience excessive skin irritation?

Stop using Bioflexor and ask a doctor if excessive skin irritation occurs or if your condition worsens or persists for more than 7 days.

Can I use Bioflexor if I am pregnant?

The safety of Bioflexor during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What should I do if Bioflexor is swallowed?

If swallowed, get medical help or contact the Poison Control Center right away.

Where should I store Bioflexor?

Store Bioflexor at a temperature between 15º-30ºC (59º-86ºF).

Packaging Info

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

Packaging configurations for Bioflexor.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Bioflexor is a pharmaceutical compound characterized by its specific chemical properties and formulation. It is presented in a dosage form suitable for therapeutic applications. The molecular weight and chemical formula are integral to its pharmacological profile, although specific values are not provided in the extracted data. The appearance of Bioflexor is consistent with standard pharmaceutical preparations, ensuring its suitability for clinical use. Inactive ingredients are included in the formulation to support stability and efficacy, although details regarding these components are not specified.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse reactions. The use of a heating pad in conjunction with this product is also contraindicated, as it may lead to excessive heat and increase the risk of burns or skin damage.

Additionally, this product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

While using this product, it is essential to avoid contact with the eyes or mucous membranes to prevent irritation. Furthermore, tight bandaging is not recommended, as it may restrict circulation and lead to complications.

Warnings and Precautions

For external use only. It is imperative to keep this product 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following conditions arise: if the condition worsens or if symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; or if excessive skin irritation occurs. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

Patients using this product should be aware that it is for external use only. It is imperative to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or the Poison Control Center should be contacted.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

Before using this product, patients should seek medical advice if there is any redness present over the affected area.

Drug Interactions

There are no reported 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 Bioflexor (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bioflexor.
Details

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a healthcare professional prior to use. It is important to note that this medication is contraindicated in children under 12 years of age who present with arthritis-like conditions.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of BioFlexor menthol gel during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Given the lack of established safety data, the use of this product should be approached with caution. No specific dosage modifications for pregnant individuals are provided; therefore, it is advisable to seek guidance from a healthcare professional regarding appropriate use during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

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

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact the Poison Control Center without delay for further guidance.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 understanding of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact the Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to emphasize that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients should be cautioned to avoid contact with the eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Finally, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

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 a temperature range of 15º to 30ºC (59º to 86ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

For patients aged 12 years and older, the medication should be applied 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 regarding the appropriate use and administration of the product. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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