Other
Nail Fungus Treatment
Nail Fungus Treatment
FDA Label NDC 84257-101
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 Maitelin Information Technology Co., Ltd. for the product Nail Fungus Treatment (NDC 84257-101). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Salicylic Acid 6.6%
Otc - Purpose
Anti-fungal
Indications & Usage
Effective for fighting against fungalcausingbacteria of fingernails or toenails: thick orridged, discolored, gel manicure/pedicuredamage, aging & brittle.
Warnings
FOR EXTERNAL USE ONLY.
Otc - Do Not Use
Don't use on children under 2 years ofage unless directed by a doctor.
Don't use it on damaged skin; otherwise, your damaged skin may be painful.
Don't use this product, if you are pregnantor nursing.
Otc - When Using
Avoid eye contact, if contact occurs, rinsethoroughly with water.
Otc - Stop Use
Stop use and consult a doctor/healthcareprofessional if irritation or symptom-sworsen.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swal-lowed, get medical help or contact a poisoncontrol center right away.
Dosage & Administration
Read all package directions and warningsbefore use.
Before the first use, soak the diseasednail in warm water to soften it. Wash anddry thoroughly, gently polish the diseasednail with a nail file to make it thinner andremove dirt, taking care not to hurt the nailbed. Then apply the liquid.
Do not scrub within 1 hour after use.
Apply the product twice a day. (In themorning and night)
After the first application, every 2-3 daysfile the surface of the diseased nail andcontinue regular usage.
Storage And Handling
Store at room temperature 15°-30°C(59°-86°F) away from direct sunlight.Prevent freezing.
Inactive Ingredient
AQUA
GARDEN BALSAM FLOWER
PHRYMA LEPTOSTACHYA WHOLE
STEMONAE RADIX
ANGELICA DAHURICA ROOT
PSEUDOLARIXAMABILIS BARK
ARTEMISIA ARGYI LEAF
ACETIC ACID
POLYOXYL 35 CASTOR OIL
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Label (Label)
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