FUNGAL NAIL TREATMENT

Manufacturer
Gaoye Marketing Inc
Effective date
2025-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:43

Label at a glance#

ProductFUNGAL NAIL TREATMENT
Active ingredientUNDECYLENIC ACID
Label structure14 sections

Dosage and administration

Directions 1. Apply the product twice a day, in the morning and at night. 2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days. 3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas. 4. For best res...

Storage and handling

Preservation method Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus,discoloration, thickening, splitting,crumbling and brittleness.

Warnings

WARNINGS SECTION

For external use only.
Do not use

● on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.
When using this product

●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.
Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

When Using

OTC - WHEN USING SECTION

When using this product

●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
1. Apply the product twice a day, in the morning and at night.
2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.
3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas.
4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.

Other information

STORAGE AND HANDLING SECTION

Preservation method
Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
Aloe Vera Extract, Canola Oil, Clove Bud Oil,Lavender Oil, Jojoba Oil, Manuka Oil, Oregano Oil,Peppermint Oil, Propolis Extract, Sweet Almond Oil.Tea Tree Oil, Tocopheryl Acetate.

Questions

OTC - QUESTIONS SECTION

Syuekisei@hotmail.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85308-002-01FUNGAL NAIL TREATMENT30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85308-002FUNGAL NAIL TREATMENT LIQUID [GAOYE MARKETING INC]11 package rows20250409_31dd1fb8-e661-eae8-e063-6394a90ab5e8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85308-00285308-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
31dd1fb8-e662-eae8-e063-6394a90ab5e831dd1fb8-e661-eae8-e063-6394a90ab5e82025-04-03WarningsExact identifier
spl id: 31dd1fb8-e662-eae8-e063-6394a90ab5e8
spl set id: 31dd1fb8-e661-eae8-e063-6394a90ab5e8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.