FDA.reportPublic FDA data

APUREE Nailtific Extra-Max Strength Antigungal

Manufacturer
Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:43

Label at a glance#

ProductAPUREE Nailtific Extra-Max Strength Antigungal
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid,Tolnaftate

OTC - PURPOSE SECTION

Sterilization

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

INDICATIONS & USAGE SECTION

Sterilization

WARNINGS SECTION

keep out of reach children

DOSAGE & ADMINISTRATION SECTION

30 ml ℮ 1.01 fl. oz

INACTIVE INGREDIENT SECTION

PEG-8,Alcohol Denat,PEG-40 Hydrogenated Castor Oil,Menthol,Aqua,Origanum Vulgare Oil,Eugenia Caryophyllus Bud Oil,
Cinnamomum Cassia Oil,Simmondsia Chinensis Seed Oil,Calophyllum Inophyllum Seed Oil,Melaleuca Alternifolia Leaf Oil,
Salicylic Acid,Eucalyptus Globulus Leaf Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.apuree.com/2323.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-662-23APUREE Nailtific Extra-Max Strength Antigungal1 in 1 BOTTLE, PLASTICLIQUID11
84167-662-23APUREE Nailtific Extra-Max Strength Antigungal5 in 1 BOXLIQUID51

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84167-66284167-662-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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

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 Extra-Max Strength AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4a633da8-dcba-349c-e063-6294a90a77022026-02-09WarningsExact identifier
ndc (package): 84167-662-23
ndc (product): 84167-662
ndc11 (package): 84167066223
spl id: 4a633da8-dcbb-349c-e063-6294a90a7702
spl set id: 4a633da8-dcba-349c-e063-6294a90a7702

Reported adverse events (FAERS/openFDA)#

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