Signature Black Bottle Tea Tree Antifungal Foot and Body Wash

Signature Black Bottle Tea Tree Antifungal Foot and Body Wash is an FDA-registered drug product whose active ingredient is TOLNAFTATE. It is labelled by Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69882-726, application M005, label effective 20231110. It is one of 53 FDA drug label records sharing the active ingredient 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 TOLNAFTATE are most often described in connection with: athlete foot, proven clinically, tinea pedis, corporis helps, effective relief, itching burning. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) Helps prevent most athlete's foot with daily use For effective relief of itching, burning and cracking

Directions Wash affected area and dry thoroughly Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily Use daily for 4 weeks; if condition persists longer, ask a doctor Prevent athlete's foot, apply once or twice daily (morning and/or night This product is not effective on the scalp or nails

Warnings For external use only Do not use on children under 2 years of age except under the advice and supervision of a doctor When using this product avoid contact with the eyes Stop use and ask a doctor if: Irritation occurs There is no improvement within 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 53 drug label records with 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 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash used for?
Uses Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) Helps prevent most athlete's foot with daily use For effective relief of itching, burning and cracking

Who makes Signature Black Bottle Tea Tree Antifungal Foot and Body Wash?
Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) is the labeler of record for Signature Black Bottle Tea Tree Antifungal Foot and Body Wash. 53 FDA label records share the active ingredient 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 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash 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 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash 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 TOLNAFTATE?
Yes. 53 FDA drug label records list 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 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash 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.