JUBLIA

Basic Information

Product Name

JUBLIA

FDA Product Code

0187-5400

Regulatory Information

NDC Product Code

0187-5400

Application Number

NDA203567

Marketing Category

C73594

Effective Date

March 31, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use JUBLIA safely and effectively. See full prescribing information for JUBLIA. JUBLIA (efinaconazole) topical solutionInitial U.S. Approval: 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

C12-15 ALKYL LACTATE

Code: GC844VRD7E

Class Code: IACT

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

CYCLOMETHICONE

Code: NMQ347994Z

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

DIISOPROPYL ADIPATE

Code: P7E6YFV72X

Class Code: IACT

EFINACONAZOLE

Quantity: 100 mg in 1 mL

Code: J82SB7FXWB

Class Code: ACTIB

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

EFINACONAZOLE

Code: J82SB7FXWB

Basic Information

Regulatory Information

Company Information

Active Ingredients

ALCOHOL

C12-15 ALKYL LACTATE

BUTYLATED HYDROXYTOLUENE

CYCLOMETHICONE

EDETATE DISODIUM

DIISOPROPYL ADIPATE

ANHYDROUS CITRIC ACID

WATER

Active Moieties

EFINACONAZOLE