MedPath

Toenail Fungus Liquid

Approved
Approval ID

361f4c5c-7fa7-0440-e063-6294a90aad9f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Shenzhen Earth Surface Trading Co., Ltd.

DUNS: 454290055

Products 1

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

Toenail Fungus Liquid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85636-001
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Toenail Fungus Liquid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
UNDECYLENIC ACIDActive
Quantity: 100 mg in 1 mL
Code: K3D86KJ24N
Classification: ACTIB
EUCALYPTOLActive
Quantity: 1000 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/15/2024

Uses

Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.
Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/15/2024

When using this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/15/2024

Keep out of reach of children.

If swallwed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/15/2024

inactive ingredients

Water

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/15/2024

DOSAGE & ADMINISTRATION

shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 10/15/2024

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/15/2024

Active ingredients

Salicylic Acid

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/15/2024

PURPOSE

Anti-fungal

WARNINGS SECTION

LOINC: 34071-1Updated: 10/15/2024

Warnings

For external use only, Some individuals may be sensitive to essential oils.
Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.
Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/15/2024

Stop use and ask a doctor if

rash occur

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 10/15/2024

Do not use

on damaged or broken skik

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