Active Ingredient
Miconazole Nitrate2%
Bodykoo Athlete Foot Cream
FDA Label NDC 85248-229
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Bodykoo Athlete Foot Cream (NDC 85248-229). 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 active ingredient, purpose, uses, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• Cures most athlete's foot between the toes.
• Effectiveness on the bottom or sides of foot is unknown.
• Relieves itching, burning, cracking, and scaling which accompany these conditions.
Warnings
For external use only
Do Not Use
on nails or scalp.
■ In or near the mouth or the eyes.
When Using
do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Stop Use
if too much irritation occurs or irritation gets worse
Ask Doctor
if too much irritation occurs or irritation gets worse
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 12 years and older:
■ Use the tip of the cap to break the seal and open the tube.
■ Wash the affected skin with soap and water and dry completely before applying.
■ For athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
■ For jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor.
■ Wash hands after each use.
■ Children under 12 years: ask a doctor.
Other Information
■ Do not use if seal on tube is broken or not visible.
■ Store between 20°C - 25°C (68°F - 77°F).
Inactive Ingredients
Camphor (SYNTHETIC), Gentiana, Glycerin, Methylparaben, Peppermint, Sophora flavescens Root Extract,
Propylene Glycol, Silicone Oil, Triethanolamine.
Principal Display Panel
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