MedPath

Ovace

Ovace Plus (sodium sulfacetamide 9.8%) Lotion

Approved
Approval ID

073a44cd-f679-48bd-b90d-cf06f32ff07d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Mission Pharmacal Company

DUNS: 008117095

Products 1

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

SULFACETAMIDE SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0178-0620
Product Classification
G
Generic Name
SULFACETAMIDE SODIUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (18)

POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEInactive
Code: 395MHJ5PUR
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 98 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/17/2023

carton

DESCRIPTION SECTION

LOINC: 34089-3Updated: 6/24/2014

DESCRIPTION:

Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

structure

Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Ovace - FDA Drug Approval Details