Folrex Cream

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including simple backache, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects reported.

Dosage and Administration

The medication should be applied to the affected area no more than three to four times daily. For children under the age of four years, it is essential to consult with a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes should be avoided, as it may lead to irritation or injury. Additionally, the product must be kept out of the reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Medical Center is advised.

Warnings and Precautions

For external use only. This product is not intended for application on wounds or damaged skin. Healthcare professionals should advise patients to discontinue use if conditions worsen, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. In such cases, consultation with a physician is recommended.

It is important to instruct patients not to bandage the area tightly after application. Additionally, care should be taken to avoid contact with the eyes.

This product should be kept out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Medical Center is advised.

Side Effects

Patients using this product should be aware that it is for external use only. In the event that conditions worsen, or if symptoms persist for more than 7 days or clear up and recur within a few days, patients are advised to discontinue use and consult a doctor. The product should not be applied to wounds or damaged skin, and it is important to avoid bandaging tightly.

Participants should also take precautions to avoid contact with eyes. It is essential to keep this product out of the reach of children. In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Medical Center is recommended.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should be evaluated by a healthcare professional prior to use. It is essential to consult with a doctor to determine the appropriateness of treatment and to discuss any potential risks or necessary adjustments in dosage for this age group.

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

There are no specific warnings or precautions regarding the use of Folrex Cream during pregnancy. The prescribing information does not indicate whether Folrex Cream is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when prescribing Folrex Cream during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. Further clinical judgment should be applied based on individual circumstances.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdose, it is imperative to seek medical assistance promptly. Healthcare professionals are advised to contact a Poison Control Medical Center without delay to ensure appropriate management and intervention.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment by medical personnel is essential. The management of overdose cases typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

Healthcare providers should remain vigilant and prepared to implement necessary protocols based on the clinical presentation of the patient. Immediate action and appropriate medical guidance are crucial in mitigating the potential risks associated with overdose situations.

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 use of the compound in these contexts.

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. It is important to emphasize the necessity of avoiding contact with the eyes, as this could lead to irritation or other adverse effects.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Medical Center for guidance. This information is crucial for ensuring patient safety and effective management of any potential emergencies.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool and dry place to maintain its efficacy. Proper storage conditions are critical to prevent degradation and ensure the product remains effective for its intended use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)