TOENAIL FUNGUS TREATMENT

TOENAIL FUNGUS TREATMENT is an FDA-registered drug product whose active ingredient is 25% UNDECYLENIC ACID. It is labelled by 100 KARMA INC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85569-005, application M005, label effective 20260703. It is one of 3 FDA drug label records sharing the active ingredient 25% 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.

Across FDA labelling, products containing 25% UNDECYLENIC ACID are most often described in connection with: helps inhibit, growth fungus, appearance nails, including discoloration, thickening splitting. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Helps inhibit the growth of fungus. Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.

▪ Wash affected area and dry thoroughly. ▪ Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or directed by a doctor. ▪ Supervise children in the use of this product.

For external use only Do not use on children under 2 years of age unless directed by a doctor on diaper rash avoid contact with eyes. Do not exceed the recommended daily dosage unless directed by a doctor. Stop and ask a doctor if ▪ irritation occurs. ▪ there is no improvement within 4 weeks. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

FDA lists 3 drug label records with 25% 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.

What is TOENAIL FUNGUS TREATMENT used for?
Helps inhibit the growth of fungus. Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.

Who makes TOENAIL FUNGUS TREATMENT?
100 KARMA INC is the labeler of record for TOENAIL FUNGUS TREATMENT. 3 FDA label records share the active ingredient 25% 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 TOENAIL FUNGUS TREATMENT 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 TOENAIL FUNGUS TREATMENT 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 25% UNDECYLENIC ACID?
Yes. 3 FDA drug label records list 25% 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 TOENAIL FUNGUS TREATMENT 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.