Nail Fungus Treatment Pen

Nail Fungus Treatment Pen is an FDA-registered drug product whose active ingredient is UNDECYLENIC ACID, TOLNAFTATE. It is labelled by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85966-005, application M005, label effective 20260604. It is one of 3 FDA drug label records sharing the active ingredient UNDECYLENIC ACID, TOLNAFTATE. 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.

Across FDA labelling, products containing UNDECYLENIC ACID, TOLNAFTATE are most often described in connection with: athlete foot, tinea pedis, effective treatment, discoloration thickening, splitting crumbling, brittleness provides, itching scaling, burning redness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

. For the effective treatment of discoloration, thickening, splitting, crumbling and brittleness. .Provides effective relief from itching, scaling, burning, redness, soreness, andirritation while curing most athlete's foot (tinea pedis) and jock itch (tinea cruris). Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use

Clean and dry the affected nail and surrounding area. Twist the base of the pen clockwise until the brush tip is saturated. Apply a thin layer to the entire nail. Let it dry for 2-3 minutes. Apply twice daily (morning and night) until a healthy nail has fully grown out. For athletes foot: Pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and jock itch, use daily for 4 weeks..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.

For external use only, Store in a cool place and avoid sunshine and heat.

FDA lists 3 drug label records with UNDECYLENIC ACID, TOLNAFTATE 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.

What is Nail Fungus Treatment Pen used for?
. For the effective treatment of discoloration, thickening, splitting, crumbling and brittleness. .Provides effective relief from itching, scaling, burning, redness, soreness, andirritation while curing most athlete's foot (tinea pedis) and jock itch (tinea cruris). Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use

Who makes Nail Fungus Treatment Pen?
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD is the labeler of record for Nail Fungus Treatment Pen. 3 FDA label records share the active ingredient UNDECYLENIC ACID, TOLNAFTATE, 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 Nail Fungus Treatment Pen come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Nail Fungus Treatment Pen 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, TOLNAFTATE?
Yes. 3 FDA drug label records list UNDECYLENIC ACID, TOLNAFTATE 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 Nail Fungus Treatment Pen 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.