Foot

Description

Smith Amish Arthritis Cream (NDC 72609-702-02) is formulated to provide penetrating relief for discomfort associated with arthritis. This cream features a fresh scent derived from natural ingredients, including arnica and eucalyptus. It is composed entirely of natural components and is designed to be non-greasy, ensuring ease of application. The product is available in a net weight of 2 ounces (59 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It provides penetrating relief for various conditions, including arthritic pain, muscle pain, joint pain, and back pain.

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. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate management and to prevent potential complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay. Prompt action is essential to mitigate any potential risks associated with ingestion.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept away from the eyes to prevent irritation.

In clinical practice, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use of the product and consult a healthcare professional.

Additionally, pregnant or breastfeeding patients are encouraged to seek advice from a health professional prior to using this product to ensure safety for both the mother and child.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. 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 (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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 individual patient factors when treating patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 substance involved, estimated dose, and time of exposure, is crucial for effective management 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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand the potential risks associated with ingestion and the need for prompt action.

Additionally, healthcare providers should instruct patients to discontinue use of 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. This guidance is crucial to ensure that patients receive appropriate care and to prevent any potential complications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to protect the product from excessive heat to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)