Lanlijen Menthol Pain Relief

Description

The product is identified by the code 51945-4 and is associated with the package label principal display panel. The effective date of this labeling is December 15, 2022. The package includes a container package image and box labeling image, both in JPEG format. The container package is represented by the image file "232-Pack.jpg," while the box labeling is depicted in the image file "232-Box.jpg."

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 recommended dosage is to apply a thin film of the medication over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

Application is contraindicated on wounds or damaged skin due to the potential for exacerbating injury or infection. The product should not be applied to irritated skin or in cases where excessive irritation develops, as this may worsen the condition.

Concurrent use with other creams, sprays, ointments, or liniments is contraindicated to prevent adverse interactions and reduce the risk of skin irritation. Additionally, the use of heating pads or devices in conjunction with this product is not recommended, as it may lead to increased skin sensitivity or burns.

Contact with eyes or mucous membranes must be avoided to prevent irritation or injury. Bandaging the area after application is contraindicated, as it may trap heat and moisture, leading to skin complications. The product should be used 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.

It is crucial to avoid application on wounds or damaged skin, as well as on irritated skin or in cases where excessive irritation develops. The product should not be used in conjunction with other creams, sprays, ointments, or liniments, nor should it be applied while using a heating pad or device.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 prior to use. Should patients experience burning discomfort or excessive skin irritation, they are instructed to stop use and seek medical advice. This is particularly important if the condition worsens, persists for more than 7 days, or if symptoms clear up and then reoccur within a few days.

Additionally, it is recommended that children under 12 years of age consult a physician before using this product to ensure safety and appropriateness of treatment.

Drug Interactions

Co-administration of this product with other topical formulations, such as 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, routine monitoring of laboratory parameters is not necessary when using this formulation.

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 prior to use. For adolescents and adults aged 12 years and older, the recommended dosage is to apply a thin film over the affected areas no more than four times daily; massage of the area is not necessary.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to 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 to weigh the benefits and risks associated with the use of this medication 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 regarding 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 mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols tailored to the specific situation.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care. Continuous assessment of the patient's condition will aid in determining the appropriate course of action.

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 the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 apply the product to wounds or damaged skin, and to avoid application on irritated skin or if excessive irritation develops.

Patients should be informed that the product should not be used in conjunction with other creams, sprays, ointments, or liniments, and should not be used with heating pads or devices. They must be cautioned to avoid contact with the eyes or mucous membranes.

Storage instructions should be clearly communicated, emphasizing the need to keep the product in a cool, dry place. Patients should also be advised against bandaging the area after application and to use the product only as directed.

After using the product, patients should wash their hands with cool water to prevent unintended contact with other areas of the body. It is recommended that patients consult a physician before use if they have sensitive skin.

Patients should be instructed to stop using the product and consult a doctor if they experience burning discomfort, excessive skin irritation, if their condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur within a few days. Additionally, 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 product remains within its specified temperature range and is protected from moisture. No special handling requirements are noted; however, adherence to the recommended storage conditions is advised to ensure optimal product performance.

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)