Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream

TOLNAFTATE 1% TOPICAL HUMAN OTC DRUG

Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream is an FDA drug label for the active ingredient TOLNAFTATE 1% manufactured by Beautivity LLC administered by TOPICAL. 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 20260629.

Generic name
TOLNAFTATE 1%
Manufacturer
Beautivity LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85398-017
Application
M005
Label effective
20260629

About this product

Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream is an FDA-registered drug product whose active ingredient is TOLNAFTATE 1%. It is labelled by Beautivity LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85398-017, application M005, label effective 20260629. It is one of 39 FDA drug label records sharing the active ingredient TOLNAFTATE 1%. 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 TOLNAFTATE 1% are most often described in connection with: apply twice, day morning, week directed, children years, cap break, tube wash, affected skin, dry completely. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Tolnaftate 1%

Indications & Usage

adults and children 12 years and over use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily between the toesonly: apply twice a day(morning and night) for 1week or as directed by a doctor on the bottomor sides of the foot: apply twice a day(morningand night)for 2 weeks or as directed by a doctor for jock itch and ringworm: apply once a day(morning or night) for 1 week or as directed by adoctor wash hands after each use children under 12 years: ask a doctor

Dosage & Administration

cures most athlete's foot (tinea pedis) cures most jock itch (tinea crurs) and ringworm(tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

FOR EXTERNAL USE ONLY on nails or scalp in or near themouth or eyes for vaginal yeast infections do not get into eyes. lf eye contact occurs, rinse thoroughly with water if too much irritationo ccurs or gets worse lf swallowed, call a poison control centre or get medical help right away.

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How products containing TOLNAFTATE 1% compare

FDA lists 39 drug label records with TOLNAFTATE 1% 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
— — Jiangxi Yudexi Pharmaceutical Co., LTD 24
— — Wenzhou Yuyuan Pharmaceutical Co., Ltd. 4
— — Beautivity LLC 3
— — 100 KARMA INC 2
— — Guangzhou Huixue Biotechnology Co., Ltd. 2

Frequently asked questions

What is Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream used for?
adults and children 12 years and over use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily between the toesonly: apply twice a day(morning and night) for 1week or as directed by a doctor on the bottomor sides of the …

Who makes Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream?
Beautivity LLC is the labeler of record for Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream. 39 FDA label records share the active ingredient TOLNAFTATE 1%, 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 Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream 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 Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream 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 1%?
Yes. 39 FDA drug label records list TOLNAFTATE 1% 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 Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream 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.