Xpect Stopain Clinical

Description

Stopain® Clinical is a maximum performance pain relief gel formulated to provide immediate and penetrating relief from conditions such as arthritis, muscle aches, and joint and back pain. The active ingredient, menthol, is present at a concentration of 10%. This formulation also includes methylsulfonylmethane (MSM) and glucosamine. The product is packaged in a net weight of 3 grams. It is manufactured for Cintas in Mason, Ohio, and is made in the USA. This product is not intended for resale.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. It provides immediate, penetrating relief from arthritis, muscle aches, and joint and back pain.

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

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied directly onto the affected area. There is no requirement for bandaging after application. The application may be repeated as necessary; however, it is important not to exceed 3 to 4 applications within a 24-hour period.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent irritation or further complications.

Warnings and Precautions

For external use only, this product must be handled with care to ensure safety and efficacy. It is imperative to avoid contact with the eyes, as this may lead to irritation or injury. Additionally, the product is flammable; therefore, it should be kept away from fire or flame to prevent any hazardous situations.

When utilizing this product, it is essential to adhere strictly to the directions provided. Users should refrain from bandaging the area tightly or applying a heating pad, as these actions may exacerbate potential side effects. Furthermore, the product should not be applied to wounds or damaged skin, as this could lead to adverse reactions.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness appears, or excessive skin irritation develops. These signs may indicate a need for reevaluation of the treatment approach.

It is crucial 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 should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be avoided. It is also flammable; therefore, it should be kept away from fire or flame.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, if redness is present or excessive irritation of the skin develops, medical advice should be sought.

Pregnant or breastfeeding patients are encouraged to consult a healthcare professional prior to use. It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Xpect Stopain Clinical (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a healthcare professional for guidance. For children aged 2 years and older, the medication can be applied directly to the affected area without the need for bandaging. It may be reapplied as necessary, but should not exceed 3 to 4 applications per day.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical assistance or contact a Poison Control Center immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness appears, or excessive skin irritation develops.

When using this product, patients must be reminded to use it only as directed. They should avoid tightly bandaging the area or using a heating pad in conjunction with the product. Additionally, patients should not apply 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 noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xpect Stopain Clinical, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)