Medicated Pain Relief

Description

The product is a pain-relieving patch available in a package of four. It is designed for topical application to provide localized relief from pain. The bulk patch formulation allows for extended use and effective delivery of active ingredients through the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, bruises, and sprains.

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

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. It should not be used in conjunction with a heating pad, as this may increase the risk of burns or skin damage. Additionally, the product is contraindicated in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

While using this product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, do not apply tight bandages, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should be instructed not to apply a tight bandage over the treated area.

Patients must be informed to discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical consultation is warranted.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age with arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if there is any redness over the affected area. During application, it is important to avoid contact with the eyes or mucous membranes, and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Medicated Pain Relief (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 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 is currently no information available regarding the use of the menthol patch during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks and fetal outcomes. Women of childbearing potential should be informed of the absence of established safety information and encouraged to discuss any concerns with their healthcare provider.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to assess the situation thoroughly and initiate appropriate management protocols based on the specific circumstances and symptoms presented.

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 to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that the product is not recommended for use in children under 12 years of age who have arthritis-like conditions. They should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients must be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Finally, healthcare providers should recommend that patients consult a doctor before using the product if there is any redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity 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 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 Medicated Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)