Leader Ice Blue

Description

LEADER is a pain relief gel formulated with 2.0% menthol, designed to provide a cooling effect upon application. The product is presented in a greaseless gel form, characterized by its Ice Blue appearance. It is packaged in a net weight of 8 ounces (226.8 grams) and is identified by the National Drug Code (NDC) 70000-0260-1. This formulation is comparable to the active ingredient found in Mineral Ice®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. The formulation provides a cooling, penetrating relief to alleviate discomfort.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. It is important to note that the product is not recommended for use in children under 2 years of age; consultation with a healthcare professional is advised in such cases.

Contraindications

The use of this product is contraindicated in patients who are concurrently using other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of this product in conjunction with heating pads or other heating devices is contraindicated due to the potential for enhanced skin irritation or burns.

Warnings and Precautions

For external use only. This product should not be used in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of heating pads or other heating devices while using this product is contraindicated, as it may exacerbate irritation or discomfort.

When utilizing this product, it is imperative to avoid contact with the eyes to prevent irritation. Bandaging should not be applied tightly over the area of application, and the product must not be used on wounds or damaged skin to ensure safety and efficacy.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if the 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 contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use with other topical pain relievers and should not be used in conjunction with heating pads or other heating devices.

During the use of this product, patients are advised to avoid contact with the eyes, refrain from tightly bandaging the area of application, and not to apply it to wounds or damaged skin.

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 those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concurrent use of this medication with other topical pain relievers is contraindicated. Co-administration may increase the risk of adverse effects and diminish the therapeutic efficacy of the individual agents.

Additionally, the application of heating pads or other heating devices in conjunction with this medication is not recommended. The combination may lead to enhanced absorption and increased risk of local irritation or systemic effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in the context of these interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

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 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 lack of data 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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should avoid using the product with heating pads or other heating devices, as this could lead to increased irritation or burns.

It is important for patients 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.

While using the product, patients should be cautioned to avoid contact with the eyes to prevent irritation. They should also be instructed not to bandage the area tightly, as this may impede circulation. Furthermore, patients should refrain from applying the product to wounds or damaged skin to avoid complications.

Storage and Handling

The product is supplied in a tightly closed container and should be stored at a controlled room temperature between 20 degrees Celsius and 25 degrees Celsius. It is essential to keep the product in a cool place and to avoid exposure to heat or open flame. Freezing the product is not permitted, and it should not be used, poured, spilled, or stored near any sources of heat. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to instruct patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)