Menthol

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those related to arthritis, simple backache, strains, and sprains.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician prior to use to determine appropriate dosing and administration.

The application should be made directly to the affected area, ensuring that the medication is evenly distributed. Care should be taken to avoid excessive application, adhering to the specified frequency to optimize therapeutic outcomes while minimizing the risk of adverse effects.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with heating pads or devices due to the potential for increased heat exposure. Contact with the eyes or mucous membranes should be avoided to prevent irritation or injury. Application to wounds or damaged skin is contraindicated to avoid exacerbating the condition. Additionally, the product should not be applied to irritated skin, as this may lead to further irritation. Bandaging the area after application is also not advised, as it may alter the intended effects of the product.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and intervention if necessary.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Tidl Sport Cryotherapy Joint Muscle. 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 application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when prescribing this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to inform patients that the product should not be used in conjunction with a heating pad or any heating device, as this may lead to adverse effects.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. Patients must be cautioned to avoid contact with the eyes and mucous membranes while using this product.

Additionally, patients should be informed that the product should not be applied to wounds, damaged skin, or irritated skin. They should also be advised against bandaging the area after application. It is essential for patients to wash their hands thoroughly with cool water after using the product to prevent unintended exposure.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Currently, there are no specific storage or handling instructions provided in the SPL text. Therefore, it is recommended that healthcare professionals follow standard storage practices for similar products, ensuring that they are kept in a suitable environment to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Tidl Sport Cryotherapy Joint Muscle, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)