Active Ingredient
Tolnaftate 1%
Nail Fungus Treatment Liquid
FDA Label NDC 85834-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Bullfighting Trading Co., Ltd. for the product Nail Fungus Treatment (NDC 85834-001). 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, use, 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
Use
For the effective treatment of nailfungus, discoloration, thickening,splitting, crumbling, and brittleness.
Warnings
Avoid contact with eyes, mouth, andopen wounds. Rinse immediately ifexposed.If irritation persists, seekmedical help.keep out of reach ofchildren and pets.
Do Not Use
On damaged skin (cuts, abrasions,eczema, sunburn).
lfyou have diabetes or poor bloodcirculation.
When Using
Skin discoloration may occur during or after use.
Stop Use
If irritation occurs. If an allergic reaction occurs.
Ask Doctor
if you are pregnant or breastfeeding.
if you have diabetes.
Keep Out Of Reach Of Children
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
Children should use under adult supervision.
Directions
Soak the affected nail inwarm water to soften it. Gently file thenail to thin it and remove dirt, beingcautious not to harm the nail bed.
Application: Apply full layers of thesolution with the brush onto affectedareas on, around, and under the nails.A light tingle or burn is normal for thefirst 10 minutes until absorbed.
Frequency: Use twice daily (morningand night). Visible results may appearin 6 weeks. Continue regular use toprevent regrowth.
Other Information
Store between 15°C to 30'C(59'F to86°F). Avoid freezing and excessiveheat above 40°C (104°F).
Inactive Ingredients
Euphorbia hirta whole, Glycerin, Hydracrylic Acid, Pseudolarix amabilis bark, Resorcinol, Water
Questions
Email: [email protected]
Principal Display Panel
1 (Label)
* Please review the disclaimer below.
