Silver Sulfadiazene
Silver Sulfadiazine Cream USP 1%
Approved
Approval ID
b03ca090-40fe-44b0-838a-69aed3424a06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 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.
Silver Sulfadiazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-118
Application NumberNDA018578
Product Classification
M
Marketing Category
C73594
G
Generic Name
Silver Sulfadiazine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 9, 2012
FDA Product Classification
INGREDIENTS (11)
SILVER SULFADIAZINEActive
Quantity: 10 g in 1000 g
Code: W46JY43EJR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT