Aquacool Red Roll

Description

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

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 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 required to assess the effectiveness of the treatment and make any necessary adjustments to the administration regimen.

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 that the patient does not exhibit any adverse reactions. This precautionary measure is essential to minimize the risk of irritation or allergic responses, thereby promoting safe usage of the product.

Side Effects

Patients should be aware of potential side effects associated with the use of this product. Caution is advised when applying the product to sensitive areas of the skin. It is recommended that a patch test be conducted prior to liberal application to ensure that no adverse reactions occur.

In clinical practice, monitoring for any unexpected reactions is essential, particularly in sensitive populations. The importance of conducting a patch test cannot be overstated, as it serves as a precautionary measure to identify any potential hypersensitivity or irritation before widespread use.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aquacool Red 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in pregnant individuals. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information regarding the use of AQUACOOL RED ROLL (menthol liquid) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this product.

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, 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 is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose. Continuous assessment and supportive measures should be prioritized to ensure patient safety and optimal outcomes.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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

View product document (PDF)