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
NDC Product Code71403-020
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateDecember 27, 2017
Generic NameUrea Foam
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