ERTACZO
ERTACZO(sertaconazole nitrate) Cream, 2%
Approved
Approval ID
2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
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.
ERTACZO
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-454
Application NumberANDA021385
Product Classification
M
Marketing Category
C73584
G
Generic Name
ERTACZO
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (7)
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Sertaconazole NitrateActive
Quantity: 20 mg in 1 g
Code: 1DV05410M5
Classification: ACTIB
ETHYLENE GLYCOLInactive
Code: FC72KVT52F
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
Light mineral oilInactive
Code: N6K5787QVP
Classification: IACT
Sorbic acidInactive
Code: X045WJ989B
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 6/1/2009
For Topical Dermatologic Use Only - Not for Oral, Ophthalmic or Intravaginal Use