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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

NDC Product Code21695-786
Application NumberANDA077447
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 16, 2009
Generic NameMometasone Furoate

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

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Mometasone Furoate - FDA Drug Approval Details