ZOVIRAX
ZOVIRAX (acyclovir) Cream 5%USE ONLY FOR COLD SORES
Approved
Approval ID
0da14760-1131-4936-9a42-c40fc4db5cd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-149
Application NumberNDA021478
Product Classification
M
Marketing Category
C73594
G
Generic Name
acyclovir
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2006
FDA Product Classification
INGREDIENTS (8)
ACYCLOVIRActive
Quantity: 50 mg in 1 g
Code: X4HES1O11F
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT