MedPath

Umecta Mousse

Umecta Mousse PI

Approved
Approval ID

53f903a2-2b5c-4584-8e91-2c9f41b883ea

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 23, 2011

Manufacturers
FDA

Innocutis Holdings LLC

DUNS: 071501252

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Urea Foam

PRODUCT DETAILS

NDC Product Code68712-020
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateDecember 23, 2011
Generic NameUrea Foam

INGREDIENTS (13)

UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
BUTANEInactive
Code: 6LV4FOR43R
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
LAURETH-4Inactive
Code: 6HQ855798J
Classification: IACT
PROPANEInactive
Code: T75W9911L6
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
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