Active Ingredient...Purpose
Tolnaftate 1%.....Antifungal
Antifungal Nail Liquid
FDA Label NDC 87710-004
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 Huanmei Cosmetics Co., Ltd. for the product Antifungal Nail (NDC 87710-004). 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, stop use and consult adoctor if:, do not use, keep out of reach of children:, inactive ingredients, while using this product:, warnings:, uses:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Stop Use And Consult Adoctor If:
If the area of application shows increased irritation If there is Consult a doctor if symptoms worsen.lf pregnant or breaslleeding.
Do Not Use
if you experience any signs of sensitivity or irritation
Keep Out Of Reach Of Children:
If accidental ingestion occurs,seek medical assistance or contact a Poison
Control Center immediately.
Inactive Ingredients
water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol,
While Using This Product:
Not for use in the eyes, mouth,or vaginal area
Warnings:
For external use only.Directions: For athlete's foot and ring worm: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. lf the nail area is infected, spray the medication onto the affected area.SHAKE WELL BEFOREUSE.Store at 5'C to30°0(41'F to 86°F) in a cool dry place.Keep tighosed and away from sunlight.
Uses:
Antifungal treatment for fingernails,toenails,and
surrounding skin.Effective against fungal nails and athlete's foot caused by fungi.
Dosage & Administration
Antifungal treatment for fingernails, toenails, and surrounding skin. Effective against fungal nails and athlete's foot caused by fungi.
For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. 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.
Label
LABEL
03 (03)
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