Otc - Active Ingredient
Active ingredientTolnaftate 1% w/w
Purpose
........Antifungal Soap
Tea Tree Oil Antifungal Soap
FDA Label NDC 85593-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Tea Tree Oil Antifungal (NDC 85593-105). 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, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
ANTIFUNGAL SUPPORT/DEEP CLEANSINGVFOR ATHLETES FOOT
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warnings
Warning
For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. Keep outof reach of children. Store in a cool, dry place.
Dosage & Administration
Gently massage for 30-60 seconds before rinsing.
Use twice daily, especially after workouts or sweating.
Indications & Usage
DIRECTIONS FOR USE:
For best results, follow these steps carefully:
1.Wet skin and soap bar.
2.Work into a rich lather.
3.Apply to affected areas (feet, groin, body folds).
4.Gently massage for 30-60 seconds before rinsing.
5.Use twice daily, especially after workouts or sweating.
Inactive Ingredient
Inactive Ingredient
Sorbitol solution, sucrose, stearic acid,
polyethylene glycol-400, water, glycerin,
sodium lauryl ether sulfate,
cocamidopropyl betaine, sodium lauryl
sulfate, lauric acid, myristic acid, sodium
hydroxide, sodium citrate
Package Label.Principal Display Panel
Labeling (85593 105 01)
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