FDA.reportPublic FDA data

PEG-40 HYDROGENATED CASTOR OIL - Guangzhou Meixi Biotechnology Co., Ltd.

Manufacturer
Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:54

Label at a glance#

ProductAPUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid,Tolnaftate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

WARNINGS SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Antibacterial

INACTIVE INGREDIENT SECTION

PEG-8,Alcohol Denat,Bis-Ethoxydiglycol Cyclohexane 1,4-Dicarboxylate,PEG-40 Hydrogenated Castor Oil,
Menthol,Aqua,Eugenia Caryophyllus (Clove) Bud Oil,Calophyllum Inophyllum Seed Oil,
Melaleuca Alternifolia Leaf Oil,Simmondsia Chinensis Seed Oil,Eucalyptus Globulus Leaf Oil,
Origanum Vulgare Oil,Cinnamomum Cassia Oil,Salicylic Acid,Urea

DOSAGE & ADMINISTRATION SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Antibacterial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1111

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.apuree.com/2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-411-02APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro2 in 1 BOXLIQUID21
84167-411-02APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro6 in 1 APPLICATORLIQUID61

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84167-41184167-411-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
UREA8W8T17847WIACT
MENTHOLL7T10EIP3AIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
ORIGANUM VULGARE LEAF0E5AT8T16UIACT
CINNAMOMUM CASSIA OILA4WO0626T5IACT
SALICYLIC ACIDO414PZ4LPZIACT
TOLNAFTATE06KB629TKVACTIB
PEG-8B697894SGQIACT
DEHYDRATED ALCOHOL3K9958V90MIACT
BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATER6MU0U9L45IACT
AQUA059QF0KO0RIACT
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL578389D6D0IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
CALOPHYLLUM INOPHYLLUM SEED OILJT3LVK84A1IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT

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
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen ProAPUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PROGuangzhou Meixi Biotechnology Co., Ltd.518abf2b-6ac8-ab9b-e063-6294a90ae6932026-05-11WarningsExact identifier
ndc (package): 84167-411-02
ndc (product): 84167-411
ndc11 (package): 84167041102
spl id: 518abf2b-6ac9-ab9b-e063-6294a90ae693
spl set id: 518abf2b-6ac8-ab9b-e063-6294a90ae693

Reported adverse events (FAERS/openFDA)#

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