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FDA Approval

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Akron Pharma Inc.
DUNS: 067878881
Effective Date
March 18, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sulfacetamide(100 mg in 1 g)
Sulfur(20 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

Akron Pharma Inc.

081225162

Products1

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

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser

Product Details

NDC Product Code
71399-0485
Route of Administration
TOPICAL
Effective Date
March 18, 2023
Code: 4NRT660KJQClass: ACTIBQuantity: 100 mg in 1 g
SulfurActive
Code: 70FD1KFU70Class: ACTIBQuantity: 20 mg in 1 g
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KXClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
PEG-60 ALMOND GLYCERIDESInactive
Code: 4Y0E651N0FClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PEG-40 STEARATEInactive
Code: ECU18C66Q7Class: IACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: GO50W2HWO8Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43MClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
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