Toplast Cool Menthol 5percent

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. One patch should be peeled from its film and applied directly to the skin. It is important to use only one patch at a time and to limit the application to a maximum duration of 12 hours.

For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. Prior to using the product, it is imperative to conduct a skin patch test on the forearm to assess for sensitivity and/or allergic reactions. The product should not be applied to wounds or damaged skin. Healthcare professionals should advise patients to consult a doctor or pharmacist before use if they have known allergies to any active or inactive ingredients.

When utilizing this product, it is essential to adhere strictly to the directions provided. Users must read and follow all instructions and warnings on the label. Care should be taken to avoid contact with the eyes, mucous membranes, or rashes. Additionally, users should refrain from tightly bandaging the area of application or applying local heat, such as heating pads.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of a rash, itching, or excessive skin irritation, persistence of symptoms beyond 7 days, recurrence of symptoms, or if swelling or blistering occurs at the site of application.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use. It is crucial to keep this product out of reach of children and pets.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should emphasize the importance of stopping the use of the product and contacting a doctor if any adverse reactions occur, including worsening of the condition, rash, itching, excessive skin irritation, persistence of symptoms beyond 7 days, or swelling or blistering at the application site.

Side Effects

Prior to using the product, patients are advised to conduct a skin patch test on their forearm to assess for sensitivity and/or allergic reactions. The product should not be used on wounds or damaged skin. Patients should consult a doctor or pharmacist before use if they have known allergies to any active or inactive ingredients.

When using this product, it is imperative that patients adhere strictly to the directions provided. Contact with the eyes, mucous membranes, or rashes should be avoided. Additionally, patients should refrain from tightly bandaging the area of application or applying local heat, such as heating pads.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of a rash, itching, or excessive skin irritation, persistence of symptoms beyond 7 days, recurrence of symptoms, or swelling or blistering of the skin at the site of application.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Toplast Cool Menthol 5percent (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is one patch at a time, with a maximum application duration of 12 hours.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been explicitly stated in the available data. Additionally, there are no specific findings related to nonclinical toxicology or animal pharmacology and toxicology provided in the extracted information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with swallowing the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 68° to 77°F (20° to 25°C). The storage area must be clean and dry, ensuring that the product is kept out of direct sunlight. Additionally, it is essential to protect the product from excessive moisture to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Toplast Cool Menthol 5percent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)