Thera Plus Cool and Heat Pain Relieving Gel Menthol

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication generously to the affected area. The product should be massaged into the painful area until it is thoroughly absorbed into the skin. This application may be repeated if necessary, but should not exceed 3 to 4 times daily. In the event that the medication comes into contact with the hands, it is advised to wash the hands with soap and water.

For children under 12 years of age, it is recommended to consult a doctor before use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, tight bandaging is not recommended, as it may compromise circulation. The use of heating pads or other heating devices in conjunction with this product is also contraindicated, as it may lead to increased risk of skin irritation or burns.

Warnings and Precautions

For external use only, this product should be applied with caution. Prior to extensive application, it is recommended to conduct a patch test on a small area of skin to assess for any adverse reactions.

The product is flammable; therefore, it must be kept away from fire or flame. It is imperative to use the product strictly as directed to ensure safety and efficacy. Care should be taken to avoid contact with the eyes and mucous membranes, as this may lead to irritation.

Application to wounds or damaged skin is contraindicated. Additionally, the product should not be bandaged tightly, nor should it be used in conjunction with heating pads or other heating devices, as this may exacerbate irritation or cause adverse effects.

In the event of redness or skin irritation, the use of the product should be discontinued immediately, and a healthcare professional should be consulted. A transient burning sensation may occur upon application; however, this typically resolves within several days.

If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and seek medical advice. In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame.

During use, patients are advised to avoid contact with the eyes and mucous membranes. It is also recommended not to apply the product to wounds or damaged skin, and to refrain from tightly bandaging the area of application. Additionally, the use of heating pads or other heating devices in conjunction with this product is not advised.

Patients may experience a transient burning sensation upon application, which typically resolves within several days. However, if redness or skin irritation occurs, it is important to discontinue use and consult a healthcare professional.

Patients should stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Thera Plus Cool and Heat Pain Relieving Gel Menthol (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This recommendation is essential to ensure safety and appropriateness of treatment in this age group.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. It is advisable to have the patient’s medical history and any relevant information about the ingested substance readily available to facilitate effective treatment.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct 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 only to recur within a few days.

When discussing the proper use of this product, healthcare providers should emphasize the following guidelines: Patients should use the product only as directed and avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, and should refrain from bandaging the area tightly. Additionally, patients should not use the product in conjunction with heating pads or other heating devices.

Providers should inform patients that if redness is present, they should discontinue use and consult a doctor. In the event of skin irritation, patients should also stop using the product. It is important to note that a transient burning sensation may occur upon application, but this generally resolves within several days.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). It is essential to keep the product in a cool, dry place, away from direct sunlight to maintain its efficacy and safety. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically, with instructions for adults and children aged 12 years and older to apply generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

Clinicians should advise patients to conduct a patch test on a small area of skin prior to full application. Additionally, patients who are pregnant or breastfeeding should consult a healthcare professional before use. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Thera Plus Cool and Heat Pain Relieving Gel Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)