sunmark antifungal

TOLNAFTATE TOPICAL HUMAN OTC DRUG

sunmark antifungal is an FDA drug label for the active ingredient TOLNAFTATE manufactured by A-S Medication Solutions 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 20231216.

Generic name
TOLNAFTATE
Manufacturer
A-S Medication Solutions
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
50090-3358
Application
M005
Label effective
20231216

About this product

sunmark antifungal is an FDA-registered drug product whose active ingredient is TOLNAFTATE. It is labelled by A-S Medication Solutions taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 50090-3358, application M005, label effective 20231216. 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.

What it is used for

Across FDA labelling, products containing TOLNAFTATE are most often described in connection with: athlete foot, clinically proven, tinea pedis, jock itch, corporis helps, daily effectively, relieves symptoms, including itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Tolnaftate 1%

Indications & Usage

Uses clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot from recurring when used daily effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Dosage & Administration

Directions wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product this product is not effective on scalp or nails For athlete's foot pay special attention to spaces between toes wear well-fitting shoes, change shoes and socks at least once daily For athlete's foot and ringworm use daily for 4 weeks For jock itch use daily for 2 weeks If condition persists longer, consult a doctor

Warnings

Warnings For external use only 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 (for athlete's foot or ringworm) or within 2 weeks (for jock itch) Do not use on children under 2 years of age except under the advice and supervision of a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

TOLNAFTATE

ACTIV-CHARCOAL ANTIFUNGAL

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ANTIFUNGAL BODY WASH

Guangzhou ChuanMa International Trading Co.,Ltd. View label

Aftate Athlete Foot Cream

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AmerisourceBergen Drug Corporation View label

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Rugby Laboratories View label

How products containing TOLNAFTATE compare

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.

Dosage formProductsManufacturerProducts
— — Guangdong Aimu Biological Technology Co., Ltd 6
— — GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 4
— — Rida LLC 4
— — Clinical Therapeutic Solutions 3
— — Guangzhou ChuanMa International Trading Co.,Ltd. 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0292-2025 METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. A-S Medication Solutions LLC Class II Ongoing 20250402
D-0631-2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2 A-S Medication Solutions LLC Class I Terminated 20240814
D-0096-2022 Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3 A-S Medication Solutions LLC. Class III Terminated 20211117
D-0358-2021 Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves. A-S Medication Solutions LLC. Class I Terminated 20210512
D-1110-2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0 A-S Medication Solutions LLC. Class II Ongoing 20180829

Frequently asked questions

What is sunmark antifungal used for?
Uses clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot from recurring when used daily effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Who makes sunmark antifungal?
A-S Medication Solutions is the labeler of record for sunmark antifungal. 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 sunmark antifungal 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 sunmark antifungal 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 sunmark antifungal been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.