Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Xttrium Laboratories, Inc.
007470579
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Xttrium Laboratories, Inc.
Xttrium Laboratories, Inc.
Xttrium Laboratories, Inc.
007470579
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ANTISEPTIC SKIN CLEANSER
Product Details
NDC Product Code
0116-0407Application Number
NDA019125Marketing Category
NDA (C73594)Route of Administration
TOPICALEffective Date
December 14, 2023HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16Class: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8WClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TBClass: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POTClass: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868Class: IACT
ChlorhexidineActive
Code: MOR84MUD8EClass: ACTIBQuantity: 4 g in 100 mL
COCO DIETHANOLAMIDEInactive
Code: 92005F972DClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT