Leader Roll-on Cooling Pain Relief

Description

LEADER™ is a roll-on cooling pain relief gel formulated with 4% menthol as the active ingredient, serving as a topical analgesic. This pain-relieving gel is indicated for the relief of arthritis, back pain, and soreness in muscles and joints. The product is presented in a hands-free roll-on applicator for ease of use. It is paraben-free and is comparable to the active ingredient found in BIOFREEZE®. Each container holds 2.5 fluid ounces (74 mL). The product is backed by a 100% money-back guarantee. The National Drug Code (NDC) for LEADER™ is 70000-0617-1.

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 dry before applying the medication.

For children under 2 years of age, it is advised to consult a healthcare professional prior to 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 adverse reactions.

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 product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, the product should be discontinued. Additionally, 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 other heating devices in conjunction with this product is also not recommended.

Patients must be advised to stop 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 crucial 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 to refrain from applying 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 not to bandage the area tightly and to wash their hands with cool water after application. The use of heating pads or heating devices in conjunction with this product is also not recommended.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For pregnant or breastfeeding individuals, it is advisable to seek guidance from a healthcare professional prior to use. The product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact should be made with the Poison Control Center at 1-800-222-1222.

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 adverse reactions when using this medication, particularly in the context of its application with other topical agents or heating devices.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Roll-on 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 no specific data available regarding the excretion of this medication in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 depend on the severity of the symptoms and the amount ingested. Continuous monitoring and supportive care may be necessary to ensure patient safety and recovery.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including 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. 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 occur again within a few days.

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

Finally, healthcare providers should encourage patients to 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

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended 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 Roll-on Cooling Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)