Pain Relief Roller

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 associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The formulation should be shaken well prior to use. 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. For children under 2 years of age, it is advised to consult a doctor before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only, this product is flammable; therefore, it must not be used while smoking or in proximity to heat or open flames. When applying this product, it is crucial to avoid contact with the eyes and mucous membranes. Additionally, it should not be applied to wounds, damaged skin, or irritated areas. Bandaging the area after application is not recommended. Users are advised to wash their hands thoroughly with cool water following application. The use of this product in conjunction with heating pads or devices is contraindicated.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

In the event of ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this 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. Additionally, 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 with cool water after use 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 recur within a few days.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as this may lead to adverse effects. It is essential to avoid concurrent use to ensure patient safety and the efficacy of the treatment.

Regarding laboratory test interactions, there are no specific interactions identified. Therefore, routine laboratory tests can be performed without concern for interference from this medication. However, standard clinical judgment should always be applied when interpreting laboratory results in the context of the patient's overall treatment plan.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Roller (menthol 4%). 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 doctor prior to use.

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

There are no specific warnings, precautions, or contraindications regarding the use of the Pain Relief Roller (menthol 4% gel) during pregnancy. Available data do not indicate any known risks associated with the use of this product in pregnant patients. However, as with any medication, healthcare professionals should consider the potential benefits and risks when recommending this product to women of childbearing potential. It is advisable for pregnant patients to consult their healthcare provider before using this product to ensure it aligns with their individual health needs and circumstances.

Lactation

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

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 this patient population.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication 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, clinicians are advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)