FDA.reportPublic FDA data

Fungal Nail Renewal

Manufacturer
Shengnan (Guangzhou) Cosmetics Co., LTD
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:48

Label at a glance#

ProductFungal Nail Renewal
Active ingredient11-HYDROXY-2-UNDECENOIC ACID
Label structure13 sections

Storage and handling

Store in a cool dry place away from direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Fungal Nail Renewal

OTC - ACTIVE INGREDIENT SECTION

Undecenoic Acid 0.5%

OTC - PURPOSE SECTION

Sterilizing

INDICATIONS & USAGE SECTION

RESTORES AND RENEWS
HYDRATES DAMAGED NAILS

WARNINGS SECTION

Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with the eyes.
Keep out of reach of children section.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Avoid contact with eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not use with other ointments, creams, sprays or liniments.

OTC - STOP USE SECTION

If swelling, blistering or other discomfort occurs,please stop using and consult doctor immediately.
If symptoms have not been relieved after using for more than 7 days, please stop using and consult doctor immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children section.

DOSAGE & ADMINISTRATION SECTION

Apply two drops each time, 2-3 times a day, do not rinse with cold water within 2 hours after use.

STORAGE AND HANDLING SECTION

Store in a cool dry place away from direct sunlight.

INACTIVE INGREDIENT SECTION

Glycerin
Propylene Glycol
Otassium Iodide
Menthol
Camellia Sinensis Seed Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84019-201-01Fungal Nail Renewal15 mL in 1 BOTTLELIQUID151
84019-201-01Fungal Nail Renewal1 in 1 BOXLIQUID11
84019-201-02Fungal Nail Renewal20 mL in 1 BOTTLELIQUID201
84019-201-02Fungal Nail Renewal1 in 1 BOXLIQUID11
84019-201-03Fungal Nail Renewal1 in 1 BOXLIQUID11
84019-201-03Fungal Nail Renewal30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84019-201FUNGAL NAIL RENEWAL (UNDECENOIC ACID) LIQUID [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]16 package rows20240125_0fbc800d-1932-3554-e063-6394a90acbf1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84019-20184019-201-01, 84019-201-02, 84019-201-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
11-HYDROXY-2-UNDECENOIC ACIDUOM92D5748ACTIB
POTASSIUM IODIDE1C4QK22F9JIACT
METAHOMOMENTHOL, (+/-)-73RQD9KEHSIACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

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
0fbc800d-1933-3554-e063-6394a90acbf10fbc800d-1932-3554-e063-6394a90acbf12024-01-24WarningsExact identifier
spl id: 0fbc800d-1933-3554-e063-6394a90acbf1
spl set id: 0fbc800d-1932-3554-e063-6394a90acbf1

Reported adverse events (FAERS/openFDA)#

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