LEXETTE
These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE (halobetasol propionate) topical foam Initial U.S. Approval: 1990
Approved
Approval ID
d5d0d307-37ad-4714-ba3f-5343672bc0e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Halobetasol propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51862-604
Application NumberNDA210566
Product Classification
M
Marketing Category
C73594
G
Generic Name
Halobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2023
FDA Product Classification
INGREDIENTS (8)
Halobetasol propionateActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Cetostearyl AlcoholInactive
Code: 2DMT128M1S
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
Benzoic AcidInactive
Code: 8SKN0B0MIM
Classification: IACT
Polyoxyl 20 Cetostearyl EtherInactive
Code: YRC528SWUY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT