Triamcinolone Acetonide
Triamcinolone Acetonide Cream, USP 0.1% For External Use. Not for Ophthalmic Use. Rx only
Approved
Approval ID
8cbde037-da83-4390-8465-7e383eee9287
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2023
Manufacturers
FDA
Saptalis Pharmaceuticals, LLC.
DUNS: 080145868
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
triamcinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71656-042
Application NumberANDA040671
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (15)
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYSORBATE 40Inactive
Code: STI11B5A2X
Classification: IACT
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: MZM1I680W0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT