Biocool

Description

This product is identified by the code 51945-4 and is associated with the effective date of April 19, 2016. The principal display panel includes an image of the carton, which is available in JPEG format. The carton is designed to contain the product, and its visual representation is referenced as "biocool tube type carton.jpg."

Uses and Indications

This drug is indicated for the activation of muscle and joint function. It is intended for use in conjunction with ultrasonic transmission treatments and sports massage to enhance therapeutic outcomes.

For optimal results, the drug should be applied in an appropriate amount to the affected area and rubbed until fully absorbed. It is recommended to apply the drug 2-3 times for increased effectiveness.

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

Dosage and Administration

For the activation of muscle and joint, the product is intended for use in conjunction with ultrasonic transmission treatments and sports massage. Healthcare professionals should apply an appropriate amount of the product onto the affected area and rub it in until fully absorbed.

For optimal results, it is recommended to apply the product 2 to 3 times in succession. This repeated application enhances the effectiveness of the treatment.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event of accidental swallowing, immediate medical assistance should be sought.

Warnings and Precautions

Use of this product should be strictly in accordance with the provided directions. It is intended for external use only and must not come into contact with the eyes. Application to wounds or damaged skin is contraindicated, as is use on irritated skin or in cases where excessive irritation develops.

Storage conditions are critical; the product should be kept at room temperature with the lid securely closed. It is essential to protect the product from excessive heat and open flames. Additionally, the use of heating pads or devices in conjunction with this product is not recommended.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals should advise patients to discontinue use and consult their physician if any adverse reactions occur, although specific instructions for cessation are not detailed in the current guidelines.

Side Effects

Patients should be advised to use the product only as directed and for external use only. It is crucial to avoid contact with the eyes, as this may lead to irritation or other adverse effects. The product should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops during use.

In terms of storage, the product must be kept at room temperature with the lid closed tightly to maintain its efficacy. It should also be protected from excessive heat or open flame. Additionally, the use of heating pads or devices in conjunction with this product is not recommended, as it may lead to adverse reactions.

These precautions are essential to ensure the safety and well-being of patients using the product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Biocool (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be closely monitored to prevent accidental ingestion of this medication. It is crucial to keep the product out of reach of children. In the event of accidental swallowing, immediate medical assistance is necessary.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

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

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or 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, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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, 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

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 ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide management decisions and optimize patient outcomes.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help immediately. This precaution is crucial to ensure the safety and well-being of children.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at room temperature, with the lid closed tightly to prevent contamination. Care should be taken to keep the product away from excessive heat or open flame to maintain its efficacy and safety.

Additional Clinical Information

The medication is administered topically, with the recommended application involving the application of an appropriate amount onto the affected area, followed by rubbing until fully absorbed. For optimal effectiveness, it is advised to apply the medication 2 to 3 times repeatedly.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)