Tommie Copper Pain Relief

Description

The product is a topical pain relief spray, formulated for external use only. It is packaged in a 4 oz container. The active ingredients include specific active ingredients not provided in the text, while the inactive ingredients consist of specific inactive ingredients not provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with simple backaches, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use. For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

This product is intended for external use only and is flammable; therefore, it must be kept away from fire or flame. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental eye contact, it is imperative to flush the eyes thoroughly with water. The product should not be applied to wounds or damaged skin, and it is essential to avoid tight bandaging of the area treated. Additionally, the use of heating pads in conjunction with this product is contraindicated.

The contents of this product are under pressure; thus, it should not be punctured or incinerated. Storage must be at temperatures not exceeding 120°F to maintain product integrity.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In cases of ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that this product is for external use only and is flammable; therefore, it should be kept away from fire or flame.

In clinical settings, participants have been advised to avoid contact with the eyes. In the event of accidental contact, it is recommended to flush the eyes thoroughly with water. Additionally, the product should not be applied to wounds or damaged skin, and tight bandaging is discouraged.

Patients should also refrain from using this product in conjunction with a heating pad. The contents are under pressure, and users are cautioned against puncturing or incinerating the container. It is critical to store the product at temperatures not exceeding 120°F.

If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop use and consult a doctor.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Tommie Copper Pain Relief (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. Caution is advised when administering to younger children, and appropriate medical guidance is essential.

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 before 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 discuss their pregnancy status and any plans for pregnancy with their healthcare provider to ensure appropriate management and care.

Lactation

Lactating mothers are advised to consult a healthcare professional if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in human milk or its effects on breastfed infants. Therefore, healthcare providers should evaluate the potential risks and benefits before prescribing this medication to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a pressurized container. It is essential to store the product at temperatures not exceeding 120°F to maintain its integrity and effectiveness. Due to the pressurized nature of the contents, it is critical to avoid puncturing or incinerating the container to prevent potential hazards. Proper handling and storage conditions are vital to ensure safety and efficacy.

Additional Clinical Information

Patients should be advised that the product is for external use only and is flammable; it should be kept away from fire or flame. Clinicians should instruct patients to avoid contact with eyes, and in the event of contact, to flush thoroughly with water. The product should not be applied to wounds or damaged skin, and patients should avoid tight bandaging or using it with a heating pad. It is important to note that the contents are under pressure, and patients should not puncture or incinerate the container. Storage should be at temperatures not exceeding 120°F. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and recur within a few days. Pregnant or breastfeeding patients should seek advice from a health professional. In case of ingestion, medical help or contact with a Poison Control Center is recommended. Patients should shake the product well before use.

The recommended route of administration is topical, with application to the affected area not exceeding 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, consultation with a doctor is advised.

Drug Information (PDF)

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

View product document (PDF)