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Sodium Sulfacetamide and Sulfur

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension In a vehicle containing Green Tea and Aloe

Approved
Approval ID

c3ff4716-6009-4e29-9da9-ea740726cc3c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 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.

Sodium Sulfacetamide and Sulfur

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42192-133
Product Classification
G
Generic Name
Sodium Sulfacetamide and Sulfur
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 11, 2018
FDA Product Classification

INGREDIENTS (20)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEInactive
Code: 5M1101WGSY
Classification: IACT
SODIUM COCOYL ISETHIONATEInactive
Code: 518XTE8493
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 80 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
SODIUM METHYL COCOYL TAURATEInactive
Code: JVL98CG53G
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
SULFURActive
Quantity: 40 mg in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

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Sodium Sulfacetamide and Sulfur - FDA Drug Approval Details