Foot Works

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises, and sprains. It provides both penetrating and cooling pain relief.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The product should be dispensed by squeezing the tube, followed by gentle massage with the roller ball head for approximately 30 seconds or until the formulation is fully absorbed.

For children under 2 years of age, it is advised to consult a doctor prior to use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it should not be used with tight bandaging, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. It is crucial not to apply the product to wounds or damaged skin, and patients should be instructed to refrain from tightly bandaging the area where the product is applied.

Patients should be closely monitored for any changes in their condition. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare provider.

Additionally, it is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly after application.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this medication 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 Foot Works (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatments should be considered in the absence of established safety profiles.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Foot Works Achy Foot Massager Pain Relieving menthol lotion. Therefore, the effects on breastfed infants and the excretion of the product in breast milk are not known. Lactating mothers should consult their healthcare provider for personalized advice regarding the use of this product while breastfeeding.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management of an overdosage.

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 product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

When using this product, it is important to avoid contact with the eyes. Patients should be informed not to apply the product to wounds or damaged skin and to refrain from bandaging the area tightly after application.

Healthcare providers should also counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its efficacy.

To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Special handling precautions should be observed to prevent misuse or accidental exposure.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. 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 Foot Works, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)