Xerese
These highlights do not include all the information needed to use XERESE safely and effectively. See full prescribing information for XERESE. XERESE (acyclovir and hydrocortisone) cream, for topical use Initial U.S. Approval: 2009
Approved
Approval ID
3b6ac164-0f1e-4f36-94a1-1fdb07d710f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2020
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acyclovir and Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-5104
Application NumberNDA022436
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acyclovir and Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 3, 2020
FDA Product Classification
INGREDIENTS (13)
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
ACYCLOVIRActive
Quantity: 50 mg in 1 g
Code: X4HES1O11F
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 10 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
Poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT