Miracle Foot Repair Cream

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of 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 product 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 product should be applied liberally to the affected area and massaged gently 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, immediate medical assistance should be sought, or the patient should contact a Poison Control center without delay. It is crucial to ensure that patients are aware of these warnings to prevent potential adverse effects associated with improper use.

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 in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

It is essential for patients to monitor for any unexpected effects and to consult healthcare professionals if they experience any adverse reactions while using the product.

Drug Interactions

No drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

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

It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control center without delay.

Geriatric Use

There is no specific information regarding the use of Miracle Foot Repair Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable when this product is used in the geriatric population.

Pregnancy

There is no specific information regarding the use of Miracle Foot Repair 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 when assessing the potential risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

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 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient is stabilized and any potential complications are addressed.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is vital for ongoing patient management and future reference.

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 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 format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening, adhering to the specified time frame for safety and efficacy, although the exact duration is not provided in the available information.

Additional Clinical Information

The route of administration for the product 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 Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)