Health Smart Medicated Foot
FDA Label NDC 52862-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Wholesale Inc Dba Home Smart Products for the product Health Smart Medicated Foot (NDC 52862-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Menthol     1.0%

Otc - Purpose

Purpose

External Analgesic

Indications & Usage

Uses

For the temporary relief of pains and itch associated with minor skin irritation on the foot:

  • Absorbs Excess Moisture
  • Helps Control Foot Odor and Odor-Causing Bacteria
  • Cools and Soothes Irritated Skin

Warnings

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with eyes.

Otc - Ask Doctor

Consult a doctor and discontinue use if

  • condition worsens
  • symptoms do not get better within 1 week.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • adults and children 2 years and over: apply to the affected area not more than 3 or 4 times daily.
  • children under 2 years of age: consult a physician.
  • for best results, wash and dry feet, sprinkle powder liberally over feet, between toes, on bottoms of feet and in shoes.

Inactive Ingredient

Inactive Ingredients

talc, sodium bicarbonate, acacia, benzethonium chloride, eucalyptus oil and peppermint oil.

Other

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED FOOT POWDER

NET WT. 10 OZ. (283g)

Package Label.Principal Display Panel

Principal Display Panel (Medicated Foot Powder)

Principal Display Panel (Medicated Foot Powder)

* Please review the disclaimer below.