MedPath

Plexion

PLEXION (sodium sulfacetamide 9.8%, sulfur 4.8%) Cleansing Cloths

Approved
Approval ID

8211c8ec-b501-4ac6-8185-b4b9758cdc1a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 26, 2019

Manufacturers
FDA

Brava Pharmaceuticals, LLC

DUNS: 078786338

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 Code57883-404
Product Classification
G
Generic Name
SULFACETAMIDE SODIUM, SULFUR
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 26, 2019
FDA Product Classification

INGREDIENTS (15)

CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SULFURActive
Quantity: 48 mg in 1 g
Code: 70FD1KFU70
Classification: ACTIB
LAPONITEInactive
Code: D703131383
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 98 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB

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Plexion - FDA Drug Approval Details