Umecta Mousse
Umecta Mousse PI
Approved
Approval ID
bbd41217-bcfa-4910-a1fd-0f24bc34372a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2017
Manufacturers
FDA
EPI Health, Inc
DUNS: 080638894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71403-020
Product Classification
G
Generic Name
Urea Foam
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 27, 2017
FDA Product Classification
INGREDIENTS (13)
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
LAURETH-4Inactive
Code: 6HQ855798J
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
BUTANEInactive
Code: 6LV4FOR43R
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
PROPANEInactive
Code: T75W9911L6
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT