Aquacool Multi 120

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients such as insert inactive ingredients here.

Uses and Indications

This drug is indicated for topical application to affected areas. It is recommended that the gel be massaged into the skin until completely absorbed. The frequency and amount of application should be adjusted based on the severity of symptoms, allowing for repeated use as necessary.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

The product is intended for external use only. Healthcare professionals should ensure that patients are advised accordingly to prevent any inappropriate application. Proper application techniques should be demonstrated to patients to maximize efficacy and minimize the risk of adverse effects.

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

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Eye Contact Direct contact with the eyes must be avoided. In the event of accidental exposure, it is imperative to rinse the eyes thoroughly with water and seek medical attention if irritation persists.

Irritation Should any signs of irritation occur, the use of the product should be discontinued immediately. Monitoring for adverse reactions is essential to ensure patient safety.

Application Technique When applying the product, it is crucial to avoid tight bandaging. This practice can lead to complications and should be strictly adhered to in order to prevent any adverse effects.

Pediatric Safety The product should be kept out of reach of children to prevent accidental ingestion or misuse. Proper storage is essential to ensure safety.

Pregnancy and Breastfeeding Healthcare providers should advise patients to consult with their physician prior to using this product if they are pregnant or breastfeeding. This precaution is vital to assess any potential risks to the mother or child.

These precautions are critical for the safe and effective use of the product, and healthcare professionals should ensure that patients are adequately informed.

Side Effects

Patients should be advised to avoid contact with eyes when using this product. In the event of irritation, it is recommended to discontinue use immediately. Additionally, patients should refrain from bandaging the area tightly to prevent potential complications.

This product should be kept out of reach of children to ensure safety. Pregnant or breastfeeding individuals are advised to consult their healthcare provider prior to use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aquacool Multi 120 (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. Healthcare professionals are encouraged to consult with a physician before administering this medication to pregnant or breastfeeding individuals.

Geriatric Use

There is no specific information regarding the use of AQUACOOL MULTI 120 menthol gel in geriatric patients, including age considerations, dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs and responses.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider before using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

The use of this product during pregnancy or breastfeeding should be discussed with a healthcare professional, as potential teratogenic effects have not been fully characterized. No information regarding non-teratogenic effects is available in the provided insert. Additionally, there is no data presented concerning nonclinical toxicology or animal pharmacology and 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 suitable for external use only. It is essential to store the product at room temperature, ensuring that it is kept out of reach of children to prevent accidental ingestion or misuse.

Care should be taken to avoid contact with the eyes during application. In the event of irritation, use should be discontinued immediately. Additionally, when applying the product, it is advised to avoid bandaging tightly to ensure proper ventilation and comfort.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)