Aquacool Red 120

Description

The drug is a white to off-white, round, biconvex tablet imprinted with "XYZ" on one side and blank on the other side. The active ingredient is insert active ingredient name here. Inactive ingredients include insert inactive ingredients here. The drug is supplied in bottles containing 30 tablets.

Uses and Indications

This drug is indicated for topical application to the desired area(s) of the skin. It is recommended to apply an appropriate amount and massage the area until the formulation is thoroughly absorbed.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

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 will depend on the specific condition being treated.

Patients should apply the product to the affected area as directed, typically using a thin layer. It is important to avoid contact with eyes, mucous membranes, and open wounds. The frequency of application may vary; therefore, healthcare professionals should provide specific instructions based on individual patient needs and the severity of the condition.

Instruct patients to wash their hands thoroughly after applying the product, unless the hands are the treated area. If a dose is missed, patients should apply the product as soon as they remember, unless it is almost time for the next scheduled application. In such cases, they should skip the missed dose and resume the regular dosing schedule.

Healthcare professionals should monitor patients for any adverse reactions and adjust the treatment regimen as necessary.

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

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 contact with the product. Regular monitoring of the application site is recommended to observe for any signs of irritation or adverse effects following 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 essential, particularly for those with known sensitivities. Adverse reactions may vary among individuals, and it is important for patients to report any unexpected or severe reactions to their healthcare provider promptly.

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 Aquacool Red 120 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For both adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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

The available data regarding the use of AQUACOOL RED 120 menthol gel during pregnancy is limited. The prescribing information does not provide specific information on the safety or risks associated with the use of this product in pregnant patients. There are no contraindications noted for use during pregnancy, nor are there any statements indicating potential risks to the fetus. Additionally, no dosage modifications or special precautions for pregnant patients are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

Nursing mothers should use caution when applying this product, as there is a potential for excretion in breast milk. The effects on nursing infants are not well studied; therefore, nursing mothers are advised to consult a healthcare provider before use.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied with an estimated shelf life of 2 years under normal room conditions. It should be stored at room temperature to maintain its efficacy and safety. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. Clinicians should advise patients to keep the product out of reach of children and to use it with caution on sensitive areas. It is also recommended that patients perform a patch test prior to liberal application on the skin to assess for any adverse reactions.

Drug Information (PDF)

This file contains official product information for Aquacool Red 120, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)