Cooling

Description

LBL Cooling Gel is a topical formulation designed for external use. It is characterized by its cooling properties, which provide a soothing effect upon application. The gel is composed of a blend of active and inactive ingredients that contribute to its efficacy and stability. The specific formulation details, including the molecular weight and chemical composition, are proprietary. The product is presented in a clear gel form, allowing for easy application and absorption into the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including but not limited to cramps, sore muscles, arthritis, muscle strains, and bruises.

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

Dosage and Administration

Adults 18 years of age and older should apply the product by massaging it into the skin at the affected areas. This application should occur before bedtime and additionally when symptoms arise. It is important to ensure that the product is thoroughly absorbed into the skin for optimal effectiveness.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat and open flames to prevent fire hazards.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During application, it is crucial to avoid contact with the eyes and mucous membranes to prevent irritation or injury. 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, as this may lead to adverse reactions.

Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is important for users to wash their hands thoroughly with cool water after using the product to minimize the risk of unintentional contact with sensitive areas.

The use of heating pads or devices in conjunction with this product is contraindicated. Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from excessive heat and open flames. Prior to use, patients with sensitive skin should consult a doctor.

While using this product, it is crucial to avoid contact with the eyes or mucous membranes. 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. Patients should refrain from applying it to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended, and hands should be washed with cool water following use. The product should not be used with heating pads or devices.

Patients are advised to discontinue 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. Furthermore, pregnant or breastfeeding individuals should seek medical advice before using this product.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to enhanced absorption and increased risk of adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse by pediatric populations.

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.

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 considered in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should evaluate the necessity of treatment against any potential risks to the mother and child.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented promptly.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

Storage and Handling

The product is supplied in a configuration that ensures safe handling and storage. It is essential to keep the product away from excessive heat and open flame, as it is flammable.

Storage should be maintained at room temperature to preserve the integrity of the product. Additionally, it is crucial to keep the product out of reach of children to ensure safety. After use, individuals are advised to wash their hands with cool water to maintain hygiene.

Additional Clinical Information

Patients aged 18 years and older are advised to massage the product into the skin at affected areas before bedtime and when symptoms arise. This product is for external use only and is flammable; therefore, it should be kept away from excessive heat and open flames. Clinicians should counsel patients to consult a doctor prior to use if they have sensitive skin.

While using the product, patients should avoid contact with eyes and mucous membranes, and it should not be applied to wounds, damaged, or irritated skin. It is important not to use the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from bandaging the area. Patients should wash their hands with cool water after application and avoid using heating pads or devices. They should discontinue use and consult a doctor if the condition worsens, symptoms persist for more than seven days, or if symptoms clear up and then recur. Pregnant or breastfeeding patients should also seek medical advice before use.

Drug Information (PDF)

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

View product document (PDF)