Medicated Pain Relief

Description

The pain relieving patch is a transdermal dosage form designed for the localized delivery of analgesic agents. It is formulated to provide sustained pain relief through the skin, allowing for continuous absorption of the active ingredients over an extended period. The patch is characterized by its adhesive backing, which ensures secure application to the skin surface. Its design facilitates the controlled release of medication, optimizing therapeutic efficacy while minimizing systemic exposure.

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

Use is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the injury or causing irritation.

• Concurrent use with a heating pad is contraindicated, as this may lead to excessive heat and potential skin damage.

• 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 or mucous membranes must be avoided to prevent irritation or injury.

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

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 tight bandages over the treated area.

Patients must be informed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

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 with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad or on children under 12 years of age with arthritis-like conditions.

Patients are advised to consult a doctor prior to use if there is redness over the affected area. While using this product, it is crucial 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 any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 are no specific statements regarding the use of the menthol patch during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when prescribing this product to pregnant patients. The absence of data necessitates a careful assessment of the potential risks versus benefits in this population. Women of childbearing potential should be informed of the lack of established safety data 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 the nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 provided 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 the eyes or mucous membranes. They should also be instructed not to bandage the area tightly after application. 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. For adults and children aged 12 years and older, it should be applied to the affected area no more than 3 to 4 times daily. 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)