Biocool Focus on

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 deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The product should not be used if any abnormalities are present, including red spots, swelling, or itching. Application in areas with existing abnormalities such as scratches, eczema, or dermatitis is contraindicated. Additionally, the product must not be applied near the eyes; in the event of contact with the eyes, immediate rinsing with water is required.

It is imperative to keep the product out of reach of children to prevent accidental ingestion or misuse. After each use, the cap should be securely closed, and the product should be stored at room temperature to maintain its efficacy and safety.

Side Effects

Patients should be advised against using the product if they experience any abnormalities, including red spots, swelling, or itching. The product is contraindicated for application on areas with existing abnormalities such as scratches, eczema, or dermatitis. Additionally, it is important to avoid contact with the eyes; in the event of accidental contact, patients should wash the area immediately with water.

Furthermore, the product should be kept out of reach of children to prevent any potential misuse or adverse effects.

Drug Interactions

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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 available prescribing information does not provide specific details regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available data. Additionally, no dosage modifications or special precautions for use during pregnancy are mentioned. 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

The safety of this product has not been established in nursing mothers. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to lactating mothers.

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 and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. 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, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting requirements.

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 or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap. After each use, it is essential to securely close the cap to maintain the integrity of the product. The product should be stored at room temperature, ensuring that it is kept in a suitable environment to preserve its efficacy. No special handling requirements are noted beyond the necessity of closing the cap tightly after use.

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 Focus on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)