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Sodium Sulfacetamide 10 Sulfur 2 cream

Sodium Sulfacetamide 10% Sulfur 2% Cream

Approved
Approval ID

a57b734d-5d6d-4cd7-8003-9174cc785e41

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 15, 2024

Manufacturers
FDA

Acella Pharmaceuticals, LLC

DUNS: 825380939

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sulfacetamide Sodium and Sulfur

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42192-150
Product Classification
G
Generic Name
Sulfacetamide Sodium and Sulfur
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 11, 2018
FDA Product Classification

INGREDIENTS (17)

BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB
SULFURActive
Quantity: 20 mg in 1 g
Code: 70FD1KFU70
Classification: ACTIB
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT

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Sodium Sulfacetamide 10 Sulfur 2 cream - FDA Drug Approval Details