Active Ingredient
Tolnaftate 1%
Sovs Antifungal Heel Repair Cream
FDA Label NDC 87786-073
13 label sections · Submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Sovs Antifungal Heel Repair Cream (NDC 87786-073). 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
Effective in the treatment of most athlete's foot (tinea pedis).
Helps prevent most athlete's foot with daily use.
For effective relief of itching, cracking, burning, scaling and discomfort
Warnings
For external use only.
Do Not Use
In children less than 2 years old.
On open skin wounds.
When Using
When using, keep out of eyes, ears, mouth and any open broken skin area. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use
Stop using and ask a doctor if irritation or rash occurs.
Ask Doctor
Stop using and ask a doctor if irritation or rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Wash the affected area and dry.
To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor).
Other Information
Store between 20-25°C (68-77°F)
Inactive Ingredients
Water, Urea , Ceramide AP, Panthenol,Shea Butter, Colloidal Oatmeal, Tea Tree Oil, Aloe Barbadensis Leaf Extract,Centella Asiatica Extract, Squalane.
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