FUNGINIX ANTI-FUNGAL TREATMENT

FUNGINIX ANTI-FUNGAL TREATMENT is an FDA-registered drug product whose active ingredient is UNDECYLENIC ACID. It is labelled by The Sisquoc Healthcare Corporation taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71229-102, application M005, label effective 20260702. 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.

Across FDA labelling, products containing UNDECYLENIC ACID are most often described in connection with: anti-fungal treatment. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES ANTI-FUNGAL TREATMENT

DIRECTIONS For the cure of most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions. Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FUNGINIX over the affected area twice daily (morning and night), or as directed by a physician. Allow 3-5 minutes for the solution to penetrate the skin and absorb fully into the surrounding tissue. FUNGINIX should be applied to cuticles, around nail edges and under nail tips where reachable with the applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces. For athlete’s foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR. WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE THE EYES VERY THOROUGHLY WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION OCCURS OR THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

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.

What is FUNGINIX ANTI-FUNGAL TREATMENT used for?
USES ANTI-FUNGAL TREATMENT

Who makes FUNGINIX ANTI-FUNGAL TREATMENT?
The Sisquoc Healthcare Corporation is the labeler of record for FUNGINIX ANTI-FUNGAL TREATMENT. 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 FUNGINIX ANTI-FUNGAL 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 FUNGINIX ANTI-FUNGAL 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 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 FUNGINIX ANTI-FUNGAL 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.