Active Ingredient
Tolnaftate 1%
Dermfree Helps With Nagelpilz Liquid
FDA Label NDC 85248-115
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 Dermfree Helps With Nagelpilz (NDC 85248-115). 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
Antifungal treatment for fingernails,toenails, and surrounding skin.Effective against fungal nails and athlete's foot caused by fungi.
Warnings
For external use only.
Do Not Use
if you experience any signs of sensitivity or irritation
When Using
Not for use in the eyes, mouth,or vaginal area.
Stop Use
If the area of application shows increased irritation
If there is Consult a doctor if symptoms worsen.If pregnant or breastfeeding
Ask Doctor
If the area of application shows increased irritation
If there is Consult a doctor if symptoms worsen.If pregnant or breastfeeding
Keep Oot Of Reach Of Children
If accidental ingestion occurs,seek medical assistance or contact a Poison Control Center immediately.
Directions
For athlete's foot and ringworm：use daily for 4 weeks.Clean the affected area and dry thoroughly.Keep away from fire and flames.For external use on nails and the immediately adjacent skin only.Use once daily, preferably before bedtime.
Unscrew the bottle cap and use the brush to apply the medicine directly to the nail.The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected area.SHAKE WELL BEFORE USE.Store at 5'c to 30°0(41'F to 86°F) in a cool dry place. Keep tightly closed and away from sunlight
Inactive Ingredients
water，euphorbia hirta whole, glycerin，hydracrylic acid, pseudolarix amabilis bark, resorcinol.
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