Perform Cool and Soothing Pain Relieving Roll-on

Description

NDC 59316-112-10, PERFORM® is a menthol-based pain-relieving gel formulated for topical application. This product is designed to provide a cool and soothing effect for sore muscles and joints. It is presented in a roll-on dosage form, facilitating easy application. The volume of the container is 3 fluid ounces (89 mL), and the gel is characterized by its fast-acting properties.

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 does not exceed 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 unintentional contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Furthermore, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat and open flame.

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

Patients should be instructed to discontinue use and seek medical advice 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. Additionally, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical consultation is advised.

In the event of ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

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

During use, patients are advised to avoid contact with the eyes or mucous membranes. It should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, patients should refrain from bandaging tightly or using the product in conjunction with a heating pad or device.

Patients are instructed to stop use and consult a doctor if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days or clear up and recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical advice should be sought.

Drug Interactions

No specific drug interactions have been identified in the available data. 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 Perform Cool and Soothing Pain Relieving Roll-on (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.

It is important to note that any conditions affecting children under 12 years of age should be discussed with a healthcare professional if symptoms persist.

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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those experiencing arthritic pain, it is important to inform them to stop use and consult a doctor if the pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

When using this product, patients should be instructed to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Patients should also be cautioned against using the product on irritated skin or if excessive irritation develops. Furthermore, they should not bandage the area tightly or use it in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at a temperature range of 20-25°C (68-77°F) in a cool, dry place, away from direct sunlight. It is essential to keep the product away from excessive heat and open flame to maintain its efficacy and safety. Proper storage conditions are crucial for ensuring the product remains effective throughout its shelf life.

Additional Clinical Information

The product 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 product 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 Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)