Menthol

Description

This product is identified by the code 51945-4 and is associated with the principal display panel. The effective date of this labeling is September 19, 2023. An accompanying image is provided for visual reference, formatted as a JPEG file. The image is labeled as "01" and is referenced by the file name e463689bfcf8fbadcc609220f3862ee.jpg.

Uses and Indications

This drug is indicated for the temporary relief of muscle soreness and minor joint pain associated with conditions such as arthritis, backache, strains, and sprains.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for this product is one piece as needed. Prior to application, the wax paper should be removed. The product should be adhered to the desired area, ensuring that the surrounding area is pressed firmly to secure proper adhesion.

It is advised to replace the product every 8 hours to maintain effectiveness. Additionally, it is important that children use this product under adult supervision to ensure safe and appropriate application.

Contraindications

The product is contraindicated for oral consumption. It should not come into contact with the eyes or mucous membranes due to the potential for irritation. Application to wounds or damaged skin is prohibited to prevent adverse reactions. Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unforeseen interactions. Additionally, the product should not be bandaged or used in conjunction with heating pads or devices, as this may alter its efficacy and safety profile.

Warnings and Precautions

For external use only; ingestion may lead to serious adverse effects. It is imperative to keep this product out of reach of children to prevent accidental ingestion. Individuals with sensitive skin should exercise caution when using this product, as it may cause irritation.

The product should be used strictly as directed. Care should be taken to avoid contact with the eyes and mucous membranes, as this may result in discomfort or injury. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may lead to unforeseen interactions or increased risk of adverse effects. Bandaging the area or using heating pads or devices in conjunction with this product is also not recommended. It should be stored in a cool, dry place, away from direct sunlight to maintain its efficacy.

In the event of any adverse reactions, the use of this product should be discontinued immediately, and the healthcare provider should be contacted for further guidance.

Side Effects

Patients should be aware that the product is intended for external use only and should not be taken internally. It is crucial to keep the product out of reach of children to prevent accidental ingestion.

In clinical practice, patients with sensitive skin are advised to consult a healthcare professional prior to use. If any adverse reactions occur, it is recommended to discontinue use immediately and seek medical advice if symptoms persist.

These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

The use of this medication is contraindicated with other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to altered efficacy or increased risk of adverse effects due to overlapping mechanisms of action or compounded irritative effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Tiger Pain Relief Patch. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be administered this medication under adult supervision. Caregivers are advised to monitor children closely during treatment to ensure safety and efficacy.

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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for use in 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 are mentioned. 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 available regarding the use of the Tiger Pain Relief Patch 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, no dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function are specified in the prescribing information. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of overdosage, it is crucial to adhere to the following guidelines to ensure patient safety and effective management.

General Precautions This product is intended for external use only and should not be ingested. Ingestion can lead to serious health complications. It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Symptoms of Overdosage While specific symptoms of overdosage may vary depending on the individual and the extent of exposure, individuals with sensitive skin may experience heightened reactions. Symptoms may include irritation, redness, or other dermatological responses.

Management Procedures In the case of suspected overdosage, immediate action should be taken. If ingestion occurs, seek medical attention promptly. For external exposure, it is advisable to wash the affected area with soap and water. Monitoring for any adverse reactions is essential, and healthcare professionals should be consulted for further evaluation and management.

Healthcare providers are encouraged to report any adverse effects or complications associated with overdosage to the appropriate regulatory authorities to enhance safety and efficacy data.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. It is important to inform patients that the product is not intended for consumption and should not be eaten.

Patients should be instructed to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin. Additionally, patients should be made aware that the product should not be used in conjunction with other ointments, creams, sprays, or liniments. They should also be advised against bandaging the area or using heating pads or devices while using the product.

In the event of any adverse reactions, patients should be instructed to discontinue use immediately and seek medical advice if symptoms persist. Furthermore, patients with sensitive skin should be encouraged to consult their healthcare provider before using the product to ensure it is appropriate for their condition.

Lastly, patients should be reminded to store the product in a cool, dry place, away from direct sunlight, to maintain its efficacy.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored in a cool, dry, and well-ventilated area to maintain its efficacy. Care should be taken to avoid exposure to direct sunlight, as this may compromise the product's quality. Proper storage conditions are essential for ensuring the product remains effective throughout its shelf life.

Additional Clinical Information

The product is administered topically, with patients instructed to take one piece as needed. The wax paper should be removed, and the product should be applied to the desired area, ensuring it is pressed down securely. It is recommended to replace the application every 8 hours.

Clinicians should advise that children use the product under adult supervision to ensure safety and proper application. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Tiger Pain Relief Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)