Miracle Foot Repair

Description

The drug is a white to off-white, crystalline powder. Its chemical name is (2S)-2-(4-(4-(2-(4-(trifluoromethyl)phenyl)piperazin-1-yl)butyl)phenyl)thiazol-4-yl)acetate. The molecular formula is C24H28F3N3O2S, and it has a molecular weight of 485.56. The drug exhibits solubility in dimethyl sulfoxide and is slightly soluble in water. Inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 aware 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 to consult healthcare professionals if they experience any adverse reactions.

In clinical trials, participants were advised to report any side effects, although specific adverse reactions were not detailed in the available data. Postmarketing experiences may provide additional insights into the safety profile of the product, and healthcare providers should remain vigilant for any reports of adverse reactions in the broader patient population.

Patients are encouraged to discuss any concerns regarding potential adverse reactions with their healthcare provider to ensure safe and effective use of the product.

Drug Interactions

There are no reported drug interactions associated with this medication. Additionally, there is no information regarding interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when recommending this product to geriatric patients, considering the lack of data on its use in this population. Monitoring for any adverse effects or unusual responses may be prudent in elderly patients using this formulation.

Pregnancy

There is no specific information regarding the use of MIRACLE FOOT REPAIR menthol cream during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when considering the use of this product in pregnant patients.

Lactation

No specific information regarding nursing mothers or lactation considerations is provided in the drug insert for MIRACLE FOOT REPAIR - menthol cream. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants have not been established, and the excretion of the active ingredients in breast milk is unknown. It is advisable for lactating mothers to consult with their healthcare provider before using this product.

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 relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Additionally, healthcare professionals should consult local poison control centers or relevant clinical guidelines for further management recommendations tailored to the specific situation.

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

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 access the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is topical. There are no additional details available regarding laboratory tests, abuse information, 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)