Cold Therapy Pain Relief Medicated

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those related to arthritis, simple backache, 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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

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 should not be used while smoking or in proximity to heat or flame.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin. Additionally, the product should not be bandaged, and hands must be washed thoroughly with cool water after application. The use of heating pads or devices in conjunction with this product is contraindicated.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that the product is for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame.

When using this product, it is important to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and it should not be bandaged. Patients are advised to wash their hands after use with cool water and to refrain from using the product in conjunction with a heating pad or device.

Patients should 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 reoccur within a few days.

Drug Interactions

The use of this medication is contraindicated in conjunction with heating pads or devices, as this may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Therapy Pain Relief Medicated (menthol). 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 no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. Additionally, the product should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Cold Therapy Pain Relief Medicated Spray (Menthol 10.5%) during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential. Given the lack of data on potential fetal impacts, it is advisable to consider alternative pain relief options that have established safety profiles during pregnancy. Further research may be necessary to clarify the implications of using this product in pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. Additionally, contacting a poison control center or a medical toxicologist for guidance on management strategies is advisable.

Documentation of the incident, including the amount ingested and the time of exposure, will aid in the assessment and treatment of the patient. Continuous monitoring and evaluation of the patient's condition are crucial to ensure appropriate management and to mitigate any potential adverse effects associated with overdosage.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This prompt action is essential to ensure the safety and well-being of the patient. Providers should emphasize the importance of not delaying in seeking help, as timely intervention can be critical.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. It is essential to keep the container tightly closed when not in use to maintain its quality. Additionally, the product should be discarded after opening to ensure safety and efficacy.

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 physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)