ANTIFUNGAL NAIL

UNDECYLENIC ACID CUTANEOUS HUMAN OTC DRUG

ANTIFUNGAL NAIL is an FDA drug label for the active ingredient UNDECYLENIC ACID manufactured by Guangzhou Huanmei Cosmetics Co., Ltd. administered by CUTANEOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260821.

Generic name
UNDECYLENIC ACID
Manufacturer
Guangzhou Huanmei Cosmetics Co., Ltd.
Product type
HUMAN OTC DRUG
Route
CUTANEOUS
Dosage form
N/A
NDC
87710-004
Application
N/A
Label effective
20260821

About this product

ANTIFUNGAL NAIL is an FDA-registered drug product whose active ingredient is UNDECYLENIC ACID. It is labelled by Guangzhou Huanmei Cosmetics Co., Ltd. taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 87710-004, label effective 20260821. It is one of 24 FDA drug label records sharing the active ingredient UNDECYLENIC ACID. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing UNDECYLENIC ACID are most often described in connection with: dosage administration, antifungal treatment, fingernails toenails, surrounding skin, effective against, fungal nails, athlete foot, caused fungi. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient...Purpose Tolnaftate 1%.....Antifungal

Indications & Usage

Dosage & Administration Antifungal treatment for fingernails, toenails, and surrounding skin. Effective against fungal nails and athlete's foot caused by fungi.

Dosage & Administration

Dosage & Administration For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. For external use on nails and the immediately adjacent skin only. Use once daily, preferably before bedtime. Unscrew the bottle cap and use the brush to apply the medicine directly to the nail. The medication will then penetrate deeply into the nail. If the nail area is infected, spray the medication onto the affected area. SHAKE WELL BEFORE USE.

Warnings

Warnings: For external use only.Directions: For athlete's foot and ring worm:use daily for 4 weeks.Clean the affected area and dry thoroughly.Keep away from fire and flames.For external use on nails and the immediately adjacent skin only.Use once daily, preferably before bedtime.Unscrew the bottle cap and use the brush to apply the medicine directly to the nail.The medication will then penetrate deeply into the nail. lf the nail area is infected, spray the medication onto the affected area.SHAKE WELL BEFOREUSE.Store at 5'C to30°0(41'F to 86°F) in a cool dry place.Keep tighosed and away from sunlight.

More products with the same ingredient

UNDECYLENIC ACID

ANTIFUNGAL

Chemco Corporation View label

ANTIFUNGAL PEN

Guangzhou Mizi Biotechnology Co., Ltd. View label

CVS Pharmacy Maximum Strength Antifungal Liquid with Aloe and Vitamin E

CVS Pharmacy View label

EmoniNail Antifungal

GG Healthworks Inc. View label

FGPER Topical Antifungal Pen

Guangzhou ChuanMa International Trading Co.,Ltd. View label

FLUSH Maximum Strength Antifungal formula

Triple Point Group, LLC View label

FUNGAL NAIL PATCHES

Guangzhou Hechuang Commercial Service Co.,Ltd. View label

How products containing UNDECYLENIC ACID compare

FDA lists 24 drug label records with UNDECYLENIC ACID as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Guangzhou Mizi Biotechnology Co., Ltd. 3
— — Blaine Labs Inc. 2
— — Chemco Corporation 2
— — GOOD BRIDGE LLC 2
— — Guangzhou ChuanMa International Trading Co.,Ltd. 2

Frequently asked questions

What is ANTIFUNGAL NAIL used for?
Dosage & Administration Antifungal treatment for fingernails, toenails, and surrounding skin. Effective against fungal nails and athlete's foot caused by fungi.

Who makes ANTIFUNGAL NAIL?
Guangzhou Huanmei Cosmetics Co., Ltd. is the labeler of record for ANTIFUNGAL NAIL. 24 FDA label records share the active ingredient UNDECYLENIC ACID, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ANTIFUNGAL NAIL come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ANTIFUNGAL NAIL prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing UNDECYLENIC ACID?
Yes. 24 FDA drug label records list UNDECYLENIC ACID as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ANTIFUNGAL NAIL been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.