SODIUM SULFACETAMIDE AND SULFUR
SODIUM SULFACETAMIDE 10% AND SULFUR 5% LOTION
Approved
Approval ID
1352eff6-8b9e-473d-9acf-c0086e1d0917
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2023
Manufacturers
FDA
BioComp Pharma, Inc.
DUNS: 829249718
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULFACETAMIDE SODIUM, SULFUR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44523-602
Product Classification
G
Generic Name
SULFACETAMIDE SODIUM, SULFUR
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (16)
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
SULFURActive
Quantity: 50 mg in 1 g
Code: 70FD1KFU70
Classification: ACTIB
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT