Miracle Foot Repair

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary protection and relief of chapped or cracked skin.

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

Dosage and Administration

Adults and children aged 2 years and older may apply the medication as needed. For children under 2 years of age, it is advised to consult a physician prior to use.

Prior to application, the affected skin area should be washed and dried thoroughly. The medication should be applied liberally to the attached area and gently massaged until fully absorbed.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control center for guidance. Prompt action is essential to ensure patient safety and mitigate potential adverse effects.

Side Effects

Patients should be advised that the product is for external use only. Adverse reactions associated with the use of this product may vary. It is important for patients to monitor for any unexpected effects and report them to their healthcare provider.

In clinical trials, participants were observed for various adverse reactions, although specific data on the frequency or nature of these reactions was not provided. Postmarketing experiences may reveal additional adverse reactions that were not identified during clinical trials.

Healthcare professionals should remain vigilant for any serious adverse reactions that may arise during the use of this product and ensure that patients are informed about the appropriate use and potential risks associated with external application.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no interactions noted between drugs and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the medication as needed. For infants and children under 2 years of age, it is advised to consult a healthcare professional before use.

Geriatric Use

There is no specific information regarding the use of MIRACLE FOOT REPAIR menthol cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of MIRACLE FOOT REPAIR menthol cream in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider before using this product.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that in the event of accidental ingestion, patients should seek medical help or contact a Poison Control center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently come into contact with the medication.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

Additional Clinical Information

The route of administration for the product is topical. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)