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Exact-Rx SODIUM SULFACETAMIDE and SULFER 10%/5% Cleanser

Exact-Rx SODIUM SULFACETAMIDE and SULFUR 10%/5% Cleanser

Approved
Approval ID

bbacc6fe-5627-4126-b26d-2a550d304f8e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 23, 2023

Manufacturers
FDA

Exact-Rx, Inc.

DUNS: 137953498

Products 1

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

SODIUM SULFACETAMIDE, SULFUR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42808-113
Product Classification
G
Generic Name
SODIUM SULFACETAMIDE, SULFUR
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 23, 2023
FDA Product Classification

INGREDIENTS (18)

ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SULFURActive
Quantity: 50 mg in 1 g
Code: 70FD1KFU70
Classification: ACTIB

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Exact-Rx SODIUM SULFACETAMIDE and SULFER 10%/5% Cleanser - FDA Drug Approval Details