FUNGAL NAIL NIGHTTIME RENEWAL PATCHES

TOLNAFTATE 1% TOPICAL HUMAN OTC DRUG

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES is an FDA drug label for the active ingredient TOLNAFTATE 1% manufactured by 100 KARMA INC 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 20260703.

Generic name
TOLNAFTATE 1%
Manufacturer
100 KARMA INC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85569-009
Application
M005
Label effective
20260703

About this product

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES is an FDA-registered drug product whose active ingredient is TOLNAFTATE 1%. It is labelled by 100 KARMA INC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85569-009, application M005, label effective 20260703. 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: affected nail, clean prepare, antifungal solution, patch firmly, toes fingers, remaining adhesive, part fully, fingertips leave. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Tolnaftate 1%

Indications & Usage

▪ Clean & prepare the affected nail. ▪ Apply the antifungal solution to the affected nail. ▪ Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips. ▪ Leave the patch on for 6–8 hours. Frequency: Use the patches consistently before bed. ▪ Maintain good foot hygiene.

Dosage & Administration

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

Warnings

For external use only on children under 2 years ofage unless directed by a doctor on diaper rash Avoid contact with eyes. do not exceed the recommended daly dosage unless directed by a doctor. mirritation occurs. there is no improvement within 4 weeks. ask a health professional before use. in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

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TOLNAFTATE 1%

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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 FUNGAL NAIL NIGHTTIME RENEWAL PATCHES used for?
▪ Clean & prepare the affected nail. ▪ Apply the antifungal solution to the affected nail. ▪ Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips. ▪ Leave the patch on for 6–8 hours. Frequency: Use the patches consistently before bed. ▪ Maintain good foot hygiene.

Who makes FUNGAL NAIL NIGHTTIME RENEWAL PATCHES?
100 KARMA INC is the labeler of record for FUNGAL NAIL NIGHTTIME RENEWAL PATCHES. 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 FUNGAL NAIL NIGHTTIME RENEWAL PATCHES 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 FUNGAL NAIL NIGHTTIME RENEWAL PATCHES 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 FUNGAL NAIL NIGHTTIME RENEWAL PATCHES 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.