Thermazene
Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream
Approved
Approval ID
338f1552-e06e-4a6b-bd67-60737684a617
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
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 Code21695-182
Application NumberNDA018810
Product Classification
M
Marketing Category
C73594
G
Generic Name
Silver Sulfadiazine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 2009
FDA Product Classification
INGREDIENTS (9)
Silver SulfadiazineActive
Quantity: 10 mg in 1 g
Code: W46JY43EJR
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Polyoxyl 40 StearateInactive
Code: 13A4J4NH9I
Classification: IACT
Isopropyl MyristateInactive
Code: 0RE8K4LNJS
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sorbitan MonooleateInactive
Code: 06XEA2VD56
Classification: IACT
MethylparabenInactive
Quantity: 0.3 mg in 1 g
Code: A2I8C7HI9T
Classification: IACT