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Bioactil

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 30 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
March 13, 2019
Active ingredient
Menthol 30 mg/1 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 2019
Label revision date
March 13, 2019
Manufacturer
POLIMEROS Y SERVICIOS S. A.
Registration number
part348
NDC root
69492-013

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Drug Overview

Bioactil is a medication, although specific details about its uses or how it works are not provided. It is packaged with labeling that includes important information for users. If you have any questions about how Bioactil may be beneficial for you, it's best to consult with a healthcare professional who can provide more personalized guidance.

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no details regarding teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects. If you have any questions or need further information about this medication, please consult your healthcare provider for guidance.

Dosage and Administration

It seems that there are no specific dosage or administration details provided in the information available. To find out how to take or apply the medication correctly, you should refer to the image labeled "Directions.jpg." This image will guide you on the proper dosage and how often you need to use the medication. Always make sure to follow the instructions provided in that image for the best results. If you have any questions or need further clarification, don’t hesitate to ask your healthcare provider.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that the container label and package include important warnings regarding the medication. However, there are no specific adverse reactions listed in the provided information. It's always a good idea to consult with your healthcare provider if you have any concerns or experience unusual symptoms while taking this medication.

Warnings and Precautions

It's important to be aware of the warnings associated with your medication. You should always check the information on the container label and package for any specific warnings.

While there are no specific general precautions or laboratory tests required for safe use, it's essential to stay informed about your health and any changes you may experience. If you notice anything unusual or have concerns, don't hesitate to reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no specific information available regarding the use of Bioactil Pain Relieving Gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. Always store it in a secure place where kids cannot access it. If you have any concerns about its use or safety, consult with a healthcare professional for guidance. Your child's well-being is the top priority, so taking these precautions is essential.

Geriatric Use

While there is no specific information about the use of Bioactil Pain Relieving Gel in older adults, it's always important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health needs and any other medications you may be taking.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and seek guidance when considering new treatments.

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 include special monitoring or safety considerations tailored for patients with 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 kidney health. They can provide guidance based on your individual situation.

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 want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health concerns during your appointments to receive the best care possible.

Storage and Handling

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you can store it in a standard environment without any special requirements.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about proper use or safety, don’t hesitate to reach out for more information.

Additional Information

No further information is available.

FAQ

What is Bioactil?

Bioactil is a drug, but specific indications or usage details are not provided.

Are there any warnings associated with Bioactil?

Warnings are shown on both the container label and package.

What should I do in case of an emergency?

No specific emergency medical help instructions are provided for Bioactil.

Is there any information about dosage for Bioactil?

Specific dosage or administration information is not provided; please refer to the image labeled 'Directions.jpg' for details.

Can I use Bioactil if I am pregnant?

There is no specific information regarding the use of Bioactil during pregnancy.

Is Bioactil safe for nursing mothers?

The provided text does not include specific warnings or recommendations for nursing mothers.

How should I store Bioactil?

No specific storage or handling instructions are provided for Bioactil.

What should I do if I have questions about Bioactil?

For any questions or concerns, consult the information on the container label or package.

Is Bioactil a controlled substance?

No controlled substance classification or details are listed for Bioactil.

What precautions should I take when using Bioactil?

No specific general precautions are listed for Bioactil.

Should I keep Bioactil away from children?

Yes, Bioactil should be kept out of reach of children.

Packaging Info

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

Packaging configurations for Bioactil.
Details

Drug Information (PDF)

This file contains official product information for Bioactil, 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 use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals are advised to refer to the accompanying image (Directions.jpg) for comprehensive dosage and administration information. This image contains essential details regarding the appropriate dosing ranges, administration routes, methods, and frequency of administration. It is crucial to follow the outlined instructions to ensure safe and effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

The product label and packaging contain essential warnings that must be reviewed prior to use. Healthcare professionals are advised to ensure that patients are informed about the information presented on both the container label and the package to promote safe usage.

There are no specific general precautions associated with the use of this product. As such, healthcare providers should remain vigilant and monitor patients for any adverse effects or unusual reactions during treatment.

No laboratory tests are required or suggested for the safe use of this product. Therefore, routine laboratory monitoring is not necessary, allowing for straightforward administration without the need for additional diagnostic evaluations.

In the event of an emergency, specific instructions for obtaining medical help are not provided. Healthcare professionals should exercise their clinical judgment and follow standard emergency protocols as needed.

Additionally, there are no specific instructions for patients to stop taking the product or to contact their doctor. It is recommended that healthcare providers maintain open communication with patients regarding any concerns or side effects that may arise during the course of treatment.

Side Effects

The available data does not specify any particular adverse reactions associated with the use of the product. It is important to note that any warnings are clearly indicated on both the container label and the package. Patients and healthcare providers should refer to these warnings for important safety information.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Bioactil.
Details

Pediatric Use

This product should be kept out of reach of children. There are no specific pediatric dosing recommendations or study outcomes provided for pediatric patients. Caution is advised when administering this product to ensure safety and prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Bioactil Pain Relieving Gel. As such, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential for increased sensitivity to topical treatments in this population. Monitoring for efficacy and adverse effects is recommended, as elderly patients may respond differently to medications compared to younger individuals.

Pregnancy

There is no specific information regarding the use of Bioactil Pain Relieving Gel during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. Given the absence of established risk categories or known fetal impacts, it is advisable to weigh the potential benefits against any unknown risks when treating women of childbearing potential. Further studies may be necessary to elucidate the safety profile of this product in pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions have not been specified; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept away from extreme temperatures and humidity. Proper handling techniques should be employed to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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