Pain Relief Therapy Patch

Description

The product is a transdermal patch identified by SPL code 34089-3. Each patch contains 4 mg of the active ingredient and is designed to deliver this active ingredient continuously over a 24-hour period. The patch is oval-shaped, measuring 10 cm x 6 cm, and is supplied in a sealed pouch. Inactive ingredients include polyisobutylene, polyethylene, ethylene vinyl acetate, silicone adhesive, aluminum foil, and a release liner.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children aged 12 years and older. The patch should be applied with the sticky side directly to the affected area and may be used for a maximum duration of 8 hours. It is recommended that the patch not be applied more than three times per day.

For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or if skin irritation develops.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or skin irritation develops. These reactions warrant immediate medical attention to ensure appropriate management and to prevent further complications.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. The safety and efficacy of this medication in this age group have not been established, and appropriate dosing may vary. It is essential for healthcare providers to evaluate the individual needs of pediatric patients when considering treatment options.

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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

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 activated charcoal may be considered to limit further absorption of the substance, provided that the patient is alert and able to protect their airway.

In cases where specific antidotes are known, they should be administered as per established protocols. Continuous assessment and supportive measures are critical in managing the patient's condition until they stabilize.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult local poison control centers for additional guidance tailored to the specific situation.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or if skin irritation develops.

When using this product, patients must be reminded to use it only as directed. They should avoid bandaging the area tightly or using it in conjunction with a heating pad. It is also important to instruct patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in packaging 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. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically and should be applied for a maximum duration of 8 hours, not exceeding three applications per day. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)