Healthwise Medicated Foot Powder

Description

HealthWise Medicated Foot Powder is a topical formulation designed for the management of foot-related conditions. The product is presented in a powder dosage form, facilitating easy application. The effective date for this formulation is December 1, 2024. An image of the product packaging is available in JPEG format, referenced as 59-204 Packaging.jpg.

Uses and Indications

This drug is indicated for the temporary relief of pain and itch associated with minor cuts, scrapes, sunburn, insect bites, prickly heat, rashes, minor burns, and minor skin irritation. Additionally, it is effective in drying the oozing of poison ivy, oak, and sumac.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication freely up to 3 or 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

For optimal results, it is essential to ensure that the skin is thoroughly dried before application. This preparation step may enhance the effectiveness of the treatment.

Contraindications

Use is contraindicated in the following situations:

• Keep out of reach of children to prevent accidental ingestion or misuse.

• Do not use if the condition worsens, as this may indicate a need for alternative treatment.

• Discontinue use if redness, irritation, swelling, or pain persists or increases, as these may be signs of an adverse reaction.

• Do not use if symptoms do not improve within 7 days or if they clear up and recur within a few days, as this may suggest a more serious underlying condition.

• Avoid contact with eyes to prevent irritation or injury.

• Not intended for use in the genital area, as this may lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and to refrain from applying the product to the genital area.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: the condition worsens; there is persistent or increasing redness, irritation, swelling, or pain; or if symptoms do not improve within 7 days, or if they resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

General precautions include ensuring that the product is kept out of reach of children to prevent accidental exposure.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to the genital area.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence or increase in redness, irritation, swelling, or pain, or if symptoms do not improve within 7 days or if they clear up and then recur within a few days.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs 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 Healthwise Medicated Foot Powder (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the product may be applied freely up to 3 or 4 times daily.

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 is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers on the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to mitigate potential risks associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Monitoring for any adverse effects is essential, and appropriate management should be initiated based on the clinical presentation.

Management procedures may include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers remain vigilant and prepared to implement interventions tailored to the specific circumstances of the overdosage incident.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if they experience persistent or increasing redness, irritation, swelling, or pain. Additionally, if symptoms do not improve within 7 days, or if they clear up and then recur within a few days, patients should also seek medical advice.

It is important to inform patients to avoid contact with their eyes while using this product. Furthermore, healthcare providers should clarify that this product is not intended for use in the genital area.

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 excessive heat, to ensure optimal conditions. Additionally, it is important to keep the product out of reach of children. Once opened, the product should be discarded to prevent any potential safety concerns.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being up to 3 or 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. 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 Healthwise Medicated Foot Powder, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)