Mometasone Furoate
Mometasone Furoate Cream 0.1%For Dermatologic Use OnlyNot for Ophthalmic Use
Approved
Approval ID
09182072-d05e-4cd4-93c0-d1c0abd6069d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mometasone Furoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-786
Application NumberANDA077447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 16, 2009
FDA Product Classification
INGREDIENTS (9)
Hexylene GlycolInactive
Code: KEH0A3F75J
Classification: IACT
Phosphoric AcidInactive
Code: E4GA8884NN
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
White WaxInactive
Code: 7G1J5DA97F
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Mometasone FuroateActive
Quantity: 1 mg in 1 g
Code: 04201GDN4R
Classification: ACTIB
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT