Toplast Cool Menthol 2percent

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. A single patch should be peeled from its film and applied directly to the skin. The patch may be worn for 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, this product should not be applied to wounds or damaged skin. Prior to use, it is essential for healthcare professionals to inquire about any known allergies to active or inactive ingredients.

When administering this product, it is imperative to adhere strictly to the provided instructions. Users must read and follow all directions and warnings indicated on the label. Care should be taken to prevent contact with the eyes, mucous membranes, or any rashes. Additionally, it is advised not to apply tight bandages or local heat, such as heating pads, to the area of application.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, rash, itching, or excessive skin irritation develops, or if symptoms persist for more than 7 days or reoccur within a few days.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use.

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

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition worsens, if a rash, itching, or excessive skin irritation develops, or if symptoms persist for more than 7 days or reoccur within a few days.

This product is contraindicated for use on wounds or damaged skin. Prior to use, patients should seek advice from a doctor or pharmacist if they have a known allergy to any active or inactive ingredients.

While using this product, it is important to avoid contact with the eyes and mucous membranes, as well as any rashes. Patients should not apply tight bandages or local heat, such as heating pads, to the area of application.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before use.

Drug Interactions

There are no specific drug interactions or drug and 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 Toplast Cool Menthol 2percent (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. The safety and efficacy of this medication in this age group have not been established, and appropriate dosing has not been determined. Caution is advised when considering treatment for children in this age range.

Geriatric Use

There is no specific information available 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 the safety and well-being of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 68° to 77°F (20° to 25°C). The storage area should be clean and dry, ensuring that the product is kept out of direct sunlight. Additionally, it is crucial 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 2percent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)