Perform Cool and Soothing Pain Relieving

Description

PERFORM® is a menthol-based pain-relieving gel formulated for the relief of sore muscles and joints. This fast-acting gel is presented in a dosage form of 4 fluid ounces (118 mL). The product is characterized by its cool and soothing properties, designed to provide immediate comfort to affected areas. The National Drug Code (NDC) for this formulation is 59316-111-20.

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, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, hands should be washed thoroughly with cool water to prevent accidental contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated for application to wounds or damaged skin, as well as to irritated skin or in cases where excessive irritation develops. Additionally, it should not be used with tight bandaging or in conjunction with heating pads or devices.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

It is imperative to use this product only as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated, as is use on irritated skin or in cases where excessive irritation develops. Additionally, patients should be cautioned against tightly bandaging the area of application or using heating pads or devices concurrently.

Patients should be instructed to discontinue use and seek medical attention if they experience any of the following: pain, swelling, or blistering of the skin; worsening of their condition; or if symptoms persist for more than 7 days or resolve only to recur within a few days. In cases of arthritic pain, if symptoms persist for more than 10 days, if redness is present, or if the patient is under 12 years of age, medical consultation is advised.

Emergency medical assistance should be sought immediately if the product is ingested. Patients should be directed to contact a Poison Control Center or seek medical help without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. The product is flammable; therefore, it should be kept away from excessive heat or open flame.

When using this product, patients are advised to avoid contact with the eyes and mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin. If excessive irritation develops, application should be discontinued. Additionally, patients should not bandage the area tightly or use it in conjunction with a heating pad or device.

Patients are instructed to stop use and consult a doctor if they experience pain, swelling, or blistering of the skin. If the condition worsens, or if symptoms persist for more than 7 days or clear up and recur within a few days, medical advice should be sought. In cases where arthritic pain persists for more than 10 days, or if redness is present, or if the product is being used on children under 12 years of age, patients should also seek medical attention.

Furthermore, it is important for patients who are pregnant or breastfeeding to consult a health professional before using this product. The product should be kept out of reach of children, and in the event of accidental ingestion, medical help should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Perform Cool and Soothing Pain Relieving (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily.

Healthcare professionals should advise caregivers to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear and then recur within a few days, if arthritic pain persists for more than 10 days, if redness is present, or in cases involving children under 12 years of age.

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. 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug 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 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 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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to use the medication only as directed by their healthcare provider. It is important to avoid contact with the eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, patients should not apply the medication to wounds or damaged skin, as this could exacerbate the condition.

Healthcare providers should caution patients against using the medication on irritated skin or if excessive irritation develops. Furthermore, patients should be informed not to bandage the area tightly or use the medication in conjunction with a heating pad or device, as this may increase the risk of adverse reactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy.

Storage should be in a cool, dry place, ensuring that the product is kept away from direct sunlight. Additionally, it is important to protect the product from excessive heat and open flame to prevent any degradation or compromise of quality. Proper handling and storage conditions are vital for preserving the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin film over the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to keep the medication out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)