Painpatrol Professional Pain Relief

Description

The Clinical Strength Menthol Formula, marketed under the name PainPatrol™, is designed for professional pain relief targeting arthritis, joints, and muscles. This formulation includes active ingredients such as menthol, glucosamine, chondroitin, arnica, and boswellia, which are known for their therapeutic properties. The product is presented in a convenient 3 fluid ounce (88 mL) dosage form and features a no mess applicator for ease of use.

Uses and Indications

This drug is indicated for the temporary relief of foot, ankle, and leg pain associated with various conditions, including arthritis, muscle aches, muscle strains, muscle sprains, and joint pain.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as directed. This formulation is contraindicated for use in children under 12 years of age.

For application, the product should be rolled onto the affected area, with a maximum frequency of four times daily. Prior to each use, it is essential to shake the container well to ensure proper mixing of the formulation.

Contraindications

Use is contraindicated in patients with wounds or irritated skin due to the potential for exacerbation of the condition. Additionally, the product should be kept out of reach of children to prevent accidental ingestion. If the condition worsens, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days, discontinue use and consult a healthcare professional. It is also contraindicated to apply tightly bandaged or in conjunction with a heating pad, as this may lead to adverse effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

Healthcare professionals are advised to exercise caution when recommending this product. Patients should be instructed to consult a physician prior to use if they have sensitive skin or are currently taking any anticoagulant medications. The product should not be applied to wounds or areas of irritated skin. Additionally, patients should be advised against tightly bandaging the area of application or using the product in conjunction with a heating pad.

It is essential for users to wash their hands thoroughly with cool water after application to prevent unintended contact with sensitive areas. Pregnant or breastfeeding individuals should seek guidance from a healthcare professional before using this product. Furthermore, it is critical to keep the product out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or poison control center.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if pain persists for more than 7 days, or if symptoms improve and then reoccur within a few days.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if pain persists for more than 7 days, or if the condition clears up and then recurs within a few days. It is also recommended that patients seek medical advice prior to use if they have sensitive skin or are currently taking any blood thinners.

The product should not be applied to wounds or irritated skin, and patients should avoid tightly bandaging the area or using it in conjunction with a heating pad. After application, it is important for patients to wash their hands with cool water to prevent unintended exposure.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is advised before use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, patients should contact a doctor or poison control center immediately.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking any anticoagulants or blood thinners. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions. Monitoring for signs of increased bleeding or bruising is advised, and dosage adjustments may be necessary based on clinical judgment.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in this age group is contraindicated. Healthcare professionals are advised to consider alternative treatments for children in this age range.

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 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 regarding 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 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, it is imperative to keep the medication out of reach of children. Accidental ingestion may occur, and in such cases, immediate action is required. Healthcare professionals should advise caregivers to contact a physician or a poison control center without delay to ensure appropriate management and intervention.

Prompt recognition of symptoms associated with overdosage is crucial for effective treatment. While specific symptoms are not detailed in the provided information, healthcare providers should remain vigilant for any unusual or severe reactions following ingestion.

Management of overdosage should be guided by the severity of symptoms and the clinical judgment of the healthcare professional involved. It is essential to follow established protocols for the assessment and treatment of overdosage cases, which may include supportive care and symptomatic treatment as necessary.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to contact a doctor or poison control center immediately if it is accidentally swallowed. Patients should be instructed to stop using the medication and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if the symptoms clear up and then reoccur within a few days.

It is important to inform patients not to apply the medication on wounds or irritated skin. They should also be cautioned against bandaging the area tightly or using the medication in conjunction with a heating pad. After application, patients should wash their hands with cool water to prevent any unintended contact with other areas of the body.

Additionally, healthcare providers should recommend that patients consult a doctor before using the medication if they have sensitive skin or are currently taking any blood thinners.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the cap is tightly closed to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of no more than four times daily. Clinicians should advise patients to shake the product well before each use.

Patients should be counseled that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames. They should consult a doctor prior to use if they have sensitive skin or are taking blood thinners. The product should not be applied to wounds or irritated skin, and patients should avoid tight bandaging or the use of heating pads in conjunction with the product. After application, hands should be washed with cool water. Pregnant or breastfeeding patients should seek advice from a health professional before use. It is crucial to keep the product out of reach of children, and in the event of accidental ingestion, a doctor or poison control center should be contacted immediately. Patients are advised to discontinue use and consult a doctor if their condition worsens, if pain persists for more than seven days, or if symptoms resolve and then reoccur within a few days.

Drug Information (PDF)

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

View product document (PDF)