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Triamcinolone Acetonide

Triamcinolone Acetonide Lotion, USP 0.1%For Dermatologic UseNot for Ophthalmic UseRx only

Approved
Approval ID

22608943-79b1-4795-9231-ac4e166309d2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 13, 2022

Manufacturers
FDA

MICRO LABS LIMITED

DUNS: 862174955

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 Code42571-385
Application NumberANDA040672
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 10, 2021
FDA Product Classification

INGREDIENTS (9)

TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT

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Triamcinolone Acetonide - FDA Drug Approval Details