FDA Product

Elocon

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Elocon

FDA Product Code

54868-2223

Regulatory Information

NDC Product Code

54868-2223

Application Number

NDA019625

Marketing Category

C73594

Effective Date

August 31, 2010

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerPhysicians Total Care, Inc.

DUNS Number

194123980

Active Ingredients

MOMETASONE FUROATE

Quantity: 1 mg in 1 g

Code: 04201GDN4R

Class Code: ACTIB

HEXYLENE GLYCOL

Code: KEH0A3F75J

Class Code: IACT

PHOSPHORIC ACID

Code: E4GA8884NN

Class Code: IACT

PROPYLENE GLYCOL MONOSTEARATE

Code: F76354LMGR

Class Code: IACT

WHITE WAX

Code: 7G1J5DA97F

Class Code: IACT

PETROLATUM

Code: 4T6H12BN9U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

MOMETASONE

Code: 8HR4QJ6DW8

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