85248-215update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-22 05:10:04

Label at a glance#

ProductAVENASTER FUNGAL NAIL CARE DUO SET (DAY)
Active ingredientUREA
Label structure13 sections

Dosage and administration

1.Clean and dry the affected area with soap and water. 2.Apply a thin layer of the Day Formula evenly to the nail surface. 3.Allow the product to absorb fully. 4.For thick nails, gently file the surface every 2‑3 days if needed. Do not over‑file or apply excessive pressure. 5.Use once daily after waking. Continue daily use to help soften thick nails and improve absorption

Storage and handling

Store at room temperature 15°C~30°C(59°F~86°F). Close cap tightly after each use. Keep away from direct sunlight and excessive moisture.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Urea 20%

Purpose

OTC - PURPOSE SECTION

Softens thickened, hardened and brittle cuticles; dissolves dead old keratin.

Use

INDICATIONS & USAGE SECTION

Softens thickened keratin, dissolves dead cuticles, moisturizes and repairs, helps improve thickened toenails, brittle nails, and dry, peeling skin around the nails caused by tinea pedis, and enhances the penetration of subsequent antibacterial ingredients.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

When Using

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

1.Clean and dry the affected area with soap and water.
2.Apply a thin layer of the Day Formula evenly to the nail surface.
3.Allow the product to absorb fully.
4.For thick nails, gently file the surface every 2‑3 days if needed. Do not over‑file or apply excessive pressure.
5.Use once daily after waking. Continue daily use to help soften thick nails and improve absorption

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°C~30°C(59°F~86°F). Close cap tightly after each use.
Keep away from direct sunlight and excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Propylene Glycol, Lactic Acid, Polyethylene Glycol, Tea Tree Oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2020

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843981798GTIN-13: 6979843981798
EAN-13: 6979843981798
GTIN storage (14 digits): 06979843981798
38cde480ac3445a6e246ec948e2439da.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-21585248-215-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-16full-release2026-06-01 01:57:42

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVENASTER FUNGAL NAIL CARE DUO SET (DAY)UREA 20% FUNGAL NAIL CARE DUO SET (DAY)Jiangxi Yudexi Pharmaceutical Co., LTD51ebecc4-391c-ff08-e063-6294a90a20ed2026-07-20WarningsExact identifier
ndc (package): 85248-215-01
ndc (product): 85248-215
ndc11 (package): 85248021501
spl id: 57073917-5801-bb21-e063-6294a90a134a
spl set id: 51ebecc4-391c-ff08-e063-6294a90a20ed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.