Biocool

Description

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

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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified 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

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.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is intended for external use only and should be applied strictly as directed. Contact with the eyes must be avoided to prevent irritation or injury. The product should not be applied to wounds, damaged skin, or areas of irritation, particularly if excessive irritation develops.

In terms of storage, the product should be kept at room temperature with the lid closed tightly to maintain its efficacy. It is important to keep the product away from excessive heat or open flame, as these conditions may compromise its integrity. Additionally, the use of heating pads or devices in conjunction with this product is not recommended, as it may lead to adverse effects.

Patients are encouraged to monitor for any signs of irritation or adverse reactions during use and to discontinue application if such symptoms occur.

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

Pregnancy

The safety of BIOCOOL Sports Gel during pregnancy has not been established. There are no specific contraindications for its use in pregnant patients, and the potential risks to the fetus are not explicitly stated in the prescribing information. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of BIOCOOL Sports Gel in pregnant patients.

Lactation

There are no specific warnings or precautions regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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, 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. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, 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 monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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 in succession.

There is no additional information 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)