Clobetasol Propionate
These highlights do not include all the information needed to use CLOBETASOL PROPIONATE SHAMPOO safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE SHAMPOO. CLOBETASOL PROPIONATE shampoo, for topical use Initial U.S. Approval: 1985
Approved
Approval ID
72c90da7-5f6a-4b8d-875d-f07ceeec295e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2021
Manufacturers
FDA
NORTHSTAR RX LLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clobetasol Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-030
Application NumberANDA214867
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (8)
Clobetasol PropionateActive
Quantity: 0.05 g in 100 mL
Code: 779619577M
Classification: ACTIB
Coco-betaineInactive
Code: 03DH2IZ3FY
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)Inactive
Code: HB1401PQFS
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
MONOSODIUM CITRATEInactive
Code: 68538UP9SE
Classification: IACT
Sodium Laureth-2 SulfateInactive
Code: ZZQ59TY3KG
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT