Leader Cooling Pain Relief

Description

LEADER™ is a topical analgesic formulated as a cooling pain relief gel, containing 4% menthol as its active ingredient. This pain-relieving gel is indicated for the alleviation of backache, muscle pain, and joint pain. The product is designed to provide soothing relief through its menthol content. It is available in a 3 fluid ounce (89 mL) container and is comparable to the active ingredient found in BIOFREEZE®. The National Drug Code (NDC) for this product is 70000-0618-1.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Additionally, tight bandaging is not advised, as it may exacerbate irritation or impede circulation. The use of heating pads or heating devices in conjunction with this product is also contraindicated due to the risk of increased irritation or burns.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin.

When utilizing this product, it is imperative to avoid contact with the eyes. The application should not be made to wounds or damaged skin, and it is contraindicated to use this product in conjunction with other ointments, creams, sprays, or liniments. Additionally, it should not be applied to irritated skin or if excessive irritation develops. Patients should be instructed not to bandage the area tightly and to wash their hands thoroughly with cool water after application. The use of heating pads or heating devices in conjunction with this product is also not recommended.

Patients must be advised to discontinue use and seek medical consultation if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and not to apply the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Additionally, patients are advised against tightly bandaging the area of application and should wash their hands with cool water after use. The use of heating pads or heating devices in conjunction with this product is also not recommended.

Patients are instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is advisable for individuals with sensitive skin to consult a doctor before using this product. Pregnant or breastfeeding individuals should also seek advice from a health professional prior to use.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the Poison Control Center (1-800-222-1222) should be contacted.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of heating pads or other heating devices in conjunction with this medication is not recommended. The use of heat may enhance the absorption of the drug, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of irritation or adverse reactions when using this medication, particularly in the absence of other topical agents or heating devices.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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, 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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use 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 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 prescribing information 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 there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay. The Poison Control Center can be reached at 1-800-222-1222 for guidance and support.

Prompt intervention is crucial in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact the Poison Control Center at 1-800-222-1222 immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients should be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. They should not use the product in conjunction with other ointments, creams, sprays, or liniments, and should refrain from applying it to irritated skin or if excessive irritation develops. Additionally, patients should be advised against bandaging the area tightly and should wash their hands with cool water after use. It is important to inform patients not to use the product with heating pads or heating devices.

Lastly, healthcare providers should recommend that patients ask a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)