MedPath

Nail Fungus Treatment

Approved
Approval ID

3b341440-9df2-bfb6-e063-6294a90a4c82

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

TT Beauty Trading Co., Ltd.

DUNS: 661400516

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85206-002
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (6)

EDETATE DISODIUMInactive
Quantity: 0.03 mg in 30 mg
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Quantity: 3 mg in 30 mg
Code: PDC6A3C0OX
Classification: IACT
TEA TREE OILActive
Quantity: 0.03 mg in 30 mg
Code: VIF565UC2G
Classification: ACTIB
AQUAInactive
Quantity: 26.334 mg in 30 mg
Code: 059QF0KO0R
Classification: IACT
JOJOBA OILActive
Quantity: 0.006 mg in 30 mg
Code: 724GKU717M
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.6 mg in 30 mg
Code: Q40Q9N063P
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Can repair cracked or discolored nails. Restore your nails to their original beauty and show off your feet or hands again with confidence.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Apply fungus treatment solution to nails, allow it to absorb and dry, apply 1-2 layers.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/31/2025

Store in a cool and dry place.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

TEA TREE OIL、 JOJOBA OIL

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/31/2025

1. Soak your feet or hands in warm water to soften your toenails or fingernails.
2. Polish your nails with a nail file, and then wipe off the dirt on your nails.
3. Apply fungus treatment solution to nails, allow it to absorb and dry, apply 1-2 layers.
4. Keep using it to get better results.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/31/2025

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2025

Please keep out of reach of children. Do not swallow.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

AQUA、
GLYCERIN、
ACETIC ACID、
EDETATE DISODIUM

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

1. Penetrates deeply into the skin and nail beds to eliminate nail and toenail fungal infections, repair and renew your damaged nails.
2. Contains a variety of plant extracts to help you restore damaged nails without causing damage to healthy nails.
3. Can repair cracked or discolored nails. Restore your nails to their original beauty and show off your feet or hands again with confidence.

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/31/2025

Discontinue use if signs of irritation or rash occur.

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Nail Fungus Treatment - FDA Drug Approval Details