APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN liquid

Drug Labeling and Warnings

Drug Details [pdf]

WARNINGS

keep out of reach childen

KEEP OUT OF REACH OF CHILDREN

keep out of reach children

ACTIVE INGREDIENT

Undecylenic Acid,Tolnaftate

PURPOSE

Antifungal

INDICATIONS & USAGE

Antifungal

INACTIVE INGREDIENT

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

6ml e 0.2

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN 
apuree pro nailtific maximum strength dual-action antifungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84167-364
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
ALCOHOL (UNII: 3K9958V90M)
MENTHOL (UNII: L7T10EIP3A)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATE (UNII: R6MU0U9L45)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
AQUA (UNII: 059QF0KO0R)
CINNAMOMUM CASSIA OIL (UNII: A4WO0626T5)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
ORIGANUM VULGARE LEAF (UNII: 0E5AT8T16U)
PEG-8 (UNII: B697894SGQ)
UREA (UNII: 8W8T17847W)
CALOPHYLLUM INOPHYLLUM SEED OIL (UNII: JT3LVK84A1)
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84167-364-02	2 in 1 BOX	05/18/2026
1		6 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/18/2026

Labeler - Guangzhou Meixi Biotechnology Co., Ltd. (625724571)

Registrant - Guangzhou Meixi Biotechnology Co., Ltd. (625724571)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(84167-364) , label(84167-364)