Lanlijen Menthol Pain Relief

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 associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the patch should be applied to the affected area after cleaning and drying the skin. The protective film should be partially peeled back, and the exposed patch should be pressed firmly onto the site of pain. The patch may remain in place for up to 8 hours and should not be used more than 4 times daily. After removal, hands should be washed with cool water to prevent accidental contact with other areas of the body.

For children under 12 years of age, a physician should be consulted prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated in the following situations:

The use of this product with other creams, sprays, ointments, or liniments is prohibited due to the potential for adverse interactions. Application to wounds or damaged skin is contraindicated to prevent further irritation or complications. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition.

The use of heating pads or devices in conjunction with this product is not recommended, as it may lead to increased absorption and potential side effects. Contact with eyes or mucous membranes must be avoided to prevent irritation or injury. Bandaging the area after application is also contraindicated, as it may alter the product's effectiveness and increase the risk of adverse reactions.

It is essential to use the product only as directed to ensure safety and efficacy.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame. Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin.

Patients must be instructed to discontinue use and seek medical advice if they experience burning discomfort, excessive skin irritation, or if their condition worsens. Additionally, if symptoms persist for more than 7 days or clear up only to reoccur within a few days, medical consultation is necessary.

General precautions include avoiding contact with the eyes and mucous membranes. The product should not be used in conjunction with other creams, sprays, ointments, or liniments. It is contraindicated for application on wounds, damaged skin, or irritated skin, particularly if excessive irritation develops. The use of heating pads or devices in conjunction with this product is not recommended.

Patients should store the product in a cool, dry place and avoid bandaging the area after application. It is imperative to use the product only as directed and to wash hands thoroughly with cool water after 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 using this product should be aware that it is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

In clinical practice, it is advised that patients with sensitive skin consult a physician before use. Should any burning discomfort or excessive skin irritation develop, or if conditions worsen, patients are instructed to stop use and seek medical advice. Symptoms that persist for more than 7 days, or that clear up and then reoccur within a few days, also warrant consultation with a healthcare professional.

Additionally, it is recommended that children under 12 years of age consult a physician prior to use.

Drug Interactions

Co-administration of this product with other topical formulations, including creams, sprays, ointments, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this product is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are necessary regarding laboratory assessments.

Packaging & NDC

Below are the non-prescription pack sizes of Lanlijen Menthol Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents aged 12 years and older, the patch should be applied to the affected area with careful removal of the remaining film while pressing the patch to the skin. The patch may be left in place for up to 8 hours and should not be used on the affected areas more than 4 times daily. After application, hands should be washed with cool water, and the affected areas should be cleaned and dried prior to application. The protective film should be partially peeled back to expose the patch before applying it to the site of pain.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage.

Recommended Actions In cases of suspected overdosage, it is essential for healthcare providers to assess the patient's clinical status promptly. Monitoring vital signs and conducting a thorough evaluation of symptoms is crucial. Supportive care should be initiated as necessary, tailored to the individual patient's needs.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms may vary based on the pharmacological profile of the substance involved and the patient's overall health condition.

Management Procedures In the event of an overdosage, standard management protocols should be followed. This may include the administration of activated charcoal if the patient presents within a suitable timeframe and is deemed appropriate. Additionally, symptomatic treatment should be provided as required, and consultation with a poison control center may be beneficial for further guidance.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to enhance the understanding of the substance's safety profile and to contribute to ongoing pharmacovigilance efforts.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to instruct patients not to use this product in conjunction with other creams, sprays, ointments, or liniments, as this may lead to adverse effects.

Patients should be informed that the product should not be applied to wounds, damaged skin, or irritated skin. They should be cautioned against using the product if excessive irritation develops. Additionally, patients should avoid using the product with heating pads or devices, as this may increase the risk of adverse reactions.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes. Patients should be instructed to store the product in a cool, dry place and not to bandage the area after application. It is crucial to use the product only as directed and to wash hands thoroughly with cool water after use.

Patients with sensitive skin should be encouraged to consult their doctor before using the product. They should also be advised to stop use and seek medical advice if they experience burning discomfort, excessive skin irritation, worsening conditions, or if symptoms persist for more than 7 days or clear up and reoccur within a few days. Furthermore, it is essential to inform patients that children under 12 years of age should consult a physician before use.

Storage and Handling

The product is supplied in a package configuration that includes specific NDC numbers. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial for ensuring the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)