Aquacool Shower

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product is intended for external use only. Healthcare professionals should ensure that the application site is clean and dry prior to administration. The recommended dosage and frequency of application should be determined based on the specific condition being treated and the patient's response to therapy.

It is essential to instruct patients to apply the product as directed, avoiding contact with eyes, mucous membranes, and open wounds. In cases of accidental contact, the area should be rinsed thoroughly with water.

Healthcare providers should monitor the patient for any adverse reactions or side effects and adjust the dosage or frequency of application as necessary. Regular follow-up appointments may be beneficial to assess the effectiveness of the treatment and make any required modifications to the administration regimen.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by minors. No other contraindications have been identified in the provided data.

Warnings and Precautions

Use of this product should be approached with caution, particularly in sensitive areas of the skin. Healthcare professionals are advised to conduct a patch test prior to liberal application to ensure patient safety and minimize the risk of adverse reactions. This precaution is essential to identify any potential sensitivity or allergic response that may occur upon application. Regular monitoring of the skin's reaction following the patch test is recommended to ensure continued safety during use.

Side Effects

Patients should be aware of potential side effects associated with the use of this product. It is advised to use the product with caution on sensitive areas of the skin. Prior to liberal application, conducting a patch test is recommended to assess individual tolerance and minimize the risk of adverse reactions.

In clinical practice, careful monitoring is suggested, particularly for those with known sensitivities. Adverse reactions may vary among individuals, and it is essential for patients to report any unexpected or severe reactions to their healthcare provider promptly.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. There are no specific dosage adjustments indicated for this age group. Care should be taken to ensure that the application does not exceed the recommended frequency to avoid potential adverse effects.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of AQUACOOL SHOWER menthol gel during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential regarding the use of this product. It is recommended that the potential risks and benefits be carefully weighed in the context of individual patient circumstances.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing 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 is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Regular monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further treatment decisions.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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. Patients should be encouraged 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 allows for ease of use, with an estimated shelf life of 2 years under normal room conditions. It is essential to shake the container well before each use to ensure proper mixing of the contents.

For application, the can should be held more than 20 cm away from the treatment area to ensure safe and effective delivery. This product is intended for external use only, and appropriate handling precautions should be observed to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)