Pain Relieving Patch

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 various conditions, including arthritis, simple backache, strains, sprains, and bruises.

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

Dosage and Administration

The pouch should be opened to remove the patch. If necessary, the patch may be cut to the desired size before application. The protective backing must be peeled off, allowing the sticky side of the patch to be applied directly to the affected area.

For adults and children aged 12 years and older, the patch may be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor prior to use.

Contraindications

Use is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and potential for adverse reactions.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

• Contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

• Tight bandaging is contraindicated to ensure proper circulation and prevent tissue damage.

• The use of heating pads or other heating devices in conjunction with this product is not recommended, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult them prior to use if they are pregnant or breastfeeding to ensure safety and appropriateness of treatment.

General precautions must be observed to ensure safe use. It is imperative to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, excessive skin irritation, presence of redness, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These actions are crucial to prevent potential complications and ensure patient safety.

Side Effects

Patients should be aware that the product is intended for external use only. It is advised that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use.

In clinical practice, patients are instructed to stop using the product and seek medical advice if any of the following occur: the condition worsens, excessive skin irritation develops, redness is observed, or if symptoms persist for more than 7 days or resolve and then recur within a few days. Additionally, patients should consult a healthcare professional before using the product if there is existing redness over the affected area.

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 Relieving Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, 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 is advisable to ensure patient safety and optimal therapeutic outcomes.

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 based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, as these could indicate an adverse response to the medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage. In cases where the substance is known to have a specific antidote or requires particular interventions, these should be implemented as per established protocols.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and symptomatic management.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin. Additionally, it is important to caution against using the product on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should emphasize that patients must stop using the product and consult a doctor if their condition worsens, if excessive skin irritation occurs, if redness is present, or if symptoms persist for more than 7 days or clear up and recur within a few days.

While using the product, patients should be advised to avoid contact with eyes and mucous membranes. They should also be instructed not to bandage the area tightly and to refrain from using the product in conjunction with heating pads or other heating devices. Lastly, patients should be encouraged to ask a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)