Desonide
DESONIDE Rx Onlycream 0.05%and lotion 0.05% For Dermatologic Use Only –Not for Ophthalmic Use –
Approved
Approval ID
ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0472-0804
Application NumberNDA019048
Product Classification
M
Marketing Category
C73605
G
Generic Name
desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 28, 2019
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DESONIDEActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0472-0803
Application NumberANDA072354
Product Classification
M
Marketing Category
C73584
G
Generic Name
desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 28, 2019
FDA Product Classification
INGREDIENTS (14)
DESONIDEActive
Quantity: 0.5 mg in 1 mL
Code: J280872D1O
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT