Flexacure

Description

The product contains active ingredients that are essential for its therapeutic efficacy. The specific composition and concentration of these active ingredients are critical for the intended pharmacological effects. The formulation is designed to ensure optimal bioavailability and stability, contributing to the overall effectiveness of the medication. Further details regarding the molecular weight, chemical structure, and dosage form are integral to understanding the product's pharmacokinetics and pharmacodynamics.

Uses and Indications

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

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

Dosage and Administration

The medication should be applied as needed. Healthcare professionals are advised to assess the patient's condition and determine the appropriate frequency of application based on individual requirements. It is essential to monitor the patient's response to treatment and adjust the application schedule accordingly to ensure optimal therapeutic outcomes.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the use of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects. Contact with eyes or mucous membranes should be avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to adhere strictly to the usage instructions provided. It is imperative that the product is not applied with tight bandaging or in conjunction with heating pads, as these practices may lead to adverse effects. Additionally, contact with the eyes or mucous membranes must be avoided, and the product should not be applied to wounds or damaged skin to prevent further complications.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than seven 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.

Furthermore, 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 that it is intended for external use only. 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, it is advised to stop use and consult a doctor. Additionally, if redness or irritation develops, patients should discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is recommended to consult a health professional prior to use. Furthermore, this product should be kept out of reach of children. In cases where the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources for any emerging data regarding potential interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the recommended application involves generously applying the product to the affected area and massaging it into the skin until fully absorbed. This process may be repeated 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 adverse effects or changes in therapeutic response, 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 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 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 have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, if redness is present, or if irritation develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. It is also important to advise patients to avoid contact with their eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product under controlled conditions to maintain its integrity and efficacy.

The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The product should be kept in its original container to protect it from moisture and light.

Special handling precautions should be observed, particularly for individuals with known allergies to shellfish or sulfur, as they should refrain from using this product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)