FUNGAL NAIL RENEWAL

Manufacturer
Medhome Pharma Inc
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:07

Label at a glance#

ProductFUNGAL NAIL RENEWAL
Active ingredientUNDECYLENIC ACID
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%

OTC - PURPOSE SECTION

Antifungal

USE IN SPECIFIC POPULATIONS SECTION

Use

Cures most Athlete's Foot (Tinea Pedis)
and Ringworm (Tinea Corporis). Relieves
itching, scaling, cracking, burning,
redness, sorenes, and irritation and
discomfort. Helps prevent most athlete's
foot (dermatophytosis) with daily use.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

avoid contact with eyes.

OTC - STOP USE SECTION

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

OTC - ASK DOCTOR SECTION

irritation occurs, there is no improvement
within 4 weeks (for athlete's foot and
ringworm).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

For athlete's foot and ringworm: use daily for 4 weeks.

Clean theaffected area and dry thoroughly.

Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.

Supervise children in the use of this product.

This product is not effective for the treatment of ringworm of the scalp or nails.

For athlete's foot: pay special attention to spaces between the toes, wear well-fitting,

ventilated shoes, and change shoes and socks at least once daily.

To prevent athlete's foot, apply once or twice daily (morning and/or night).

Apply to skin around the nail and cuticle.

INFORMATION FOR PATIENTS SECTION

Store at room temperature 15-30℃ (59-86℉)

INACTIVE INGREDIENT SECTION

water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.

DOSAGE & ADMINISTRATION SECTION

30ml/1OZ

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
84007-130-01FUNGAL NAIL RENEWAL30 mL in 1 BOTTLELIQUID301

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84007-13084007-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
3ffbccdb-f915-4130-e063-6394a90a97123ffbccdb-f914-4130-e063-6394a90a97122025-09-29WarningsExact identifier
spl id: 3ffbccdb-f915-4130-e063-6394a90a9712
spl set id: 3ffbccdb-f914-4130-e063-6394a90a9712

Reported adverse events (FAERS/openFDA)#

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