Aquacool Multi Roll

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for topical application to affected areas. The gel should be massaged into the skin until completely absorbed. It may be reapplied as needed, with the frequency and amount of use tailored to the patient's symptoms.

There are no 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 medication is applied exclusively to the affected area of the skin. Prior to application, the area should be cleaned and dried thoroughly.

The recommended dosage and frequency of administration will depend on the specific condition being treated. It is essential to follow the prescribed dosing regimen, which may vary based on individual patient needs and response to therapy.

Healthcare professionals should instruct patients to apply the medication as directed, avoiding contact with eyes, mucous membranes, and open wounds. If irritation or an adverse reaction occurs, patients should be advised to discontinue use and consult their healthcare provider.

For optimal results, adherence to the prescribed treatment plan is crucial, and any adjustments to the dosage or frequency should be made under the guidance of a qualified healthcare professional.

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 maintain proper circulation and prevent additional irritation.

Pediatric Safety The product should be kept out of reach of children to prevent accidental ingestion or misuse. It is advisable to educate caregivers on the importance of safe storage practices.

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 necessary to evaluate potential risks and benefits in these populations.

Side Effects

Patients should be advised to avoid contact with the eyes when using the product. In the event of irritation, it is recommended to discontinue use immediately. Additionally, patients should refrain from bandaging the area tightly and ensure that the product is kept out of reach of children.

For pregnant or breastfeeding individuals, it is important to consult a healthcare professional before use. No specific side effects have been reported in clinical trials or postmarketing experiences; however, the aforementioned precautions should be strictly followed to ensure safety and minimize the risk of adverse reactions.

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 Roll (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of the medication. Healthcare professionals are advised 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 ROLL menthol gel in geriatric patients, including 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 for any potential adverse effects or interactions. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety and well-being of both the mother and the nursing infant.

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 implement supportive care measures, 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 the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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 non-teratogenic effects have been reported in the available data. Additionally, there is no information provided regarding animal pharmacology and toxicology studies.

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 to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

This product is supplied in a configuration that ensures safety and efficacy for external use only. It is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

The product should be stored in a cool, dry place, away from direct sunlight and heat sources. It is important to avoid contact with the eyes during application. In the event of irritation, use should be discontinued immediately. Additionally, care should be taken to avoid bandaging the area tightly after application to ensure proper ventilation and comfort.

Additional Clinical Information

The gel is intended for topical administration, applied directly to affected areas. Patients should massage the gel into the skin until fully absorbed and may repeat the application as needed, adjusting the frequency based on symptom control.

Clinicians should counsel patients on the following precautions: the gel is for external use only, and contact with the eyes should be avoided. Patients should discontinue use if irritation occurs and should not bandage the area tightly. It is important to keep the product out of reach of children and to consult a healthcare provider before use if pregnant or breastfeeding.

Drug Information (PDF)

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

View product document (PDF)