Medicated Pain Relief

Description

The Pain Relief Medicated Patch is a transdermal dosage form designed for the localized relief of pain. It delivers active ingredients through the skin to target affected areas. The patch is formulated to provide sustained release of medication, ensuring prolonged therapeutic effects. Its design allows for easy application and removal, making it suitable for various patient needs. The patch is characterized by its adhesive backing, which ensures secure placement on the skin during use.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, bursitis, muscle sprains, and bruises.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves the careful removal of the backing film from the patch. One patch should be applied to the affected area. This application may be repeated as necessary, but should not exceed four times daily.

For children 12 years of age or younger, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as it may exacerbate adverse effects. Contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the potential for increased sensitivity and adverse reactions.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients against tightly bandaging the area of application or using a heating pad concurrently, as these practices may exacerbate adverse effects.

Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, as this may lead to further complications.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist beyond 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops. These signs may indicate a need for reevaluation of the treatment plan.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential health risks associated with ingestion.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid bandaging tightly or using a heating pad during application. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or the development of irritation also necessitates stopping use and seeking medical advice.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health 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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 understanding of the compound's potential effects in these areas.

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 to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days, or if any redness or irritation develops.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned against bandaging the area tightly or using a heating pad while using the product. Additionally, it is crucial to advise 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 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. For adults and children over 12 years, one patch should be applied to the affected area, with the option to repeat this application as necessary, not exceeding four times daily. For children aged 12 years or younger, it is advised to consult a doctor before use. No additional information is 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)