Aquacool Blue Roll

Description

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

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 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. In the event of accidental contact, the area should be rinsed thoroughly with water.

Patients should be advised to wash their hands after applying the medication, unless the hands are the treated area. Regular monitoring of the treatment area is recommended to assess for any adverse reactions or lack of therapeutic response.

In case of persistent symptoms or any signs of irritation, patients should be instructed to consult their healthcare provider for further evaluation and potential adjustment of the treatment plan.

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 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 advised to use the product with caution on sensitive areas of the skin. Prior to liberal application, it is recommended that a patch test be conducted to assess for any potential adverse reactions. This precautionary measure is essential to minimize the risk of localized irritation or other skin-related issues.

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 Blue Roll (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

There is no specific information regarding the use of AQUACOOL BLUE ROLL menthol gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when considering the use of this product in pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 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 exposure, is vital for ongoing management and potential reporting requirements.

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 for patients to understand the potential risks associated with improper access to the medication by young children. 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, ensuring that it is kept out of reach of children. This product is intended for external use only, and appropriate precautions should be taken to prevent accidental ingestion or misuse.

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

View product document (PDF)