DESCRIPTION
id: 40c25bcb-6d63-43ec-b216-1b5ae5b79bc6
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-[(4-aminophenyl)sulfony]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of Sodium Sulfacetamide 9% & Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: aloe vera, fragrance, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl tau rate, sodium thiosulfate, stearyl alcohol and xanthan gum.
CLINICAL PHARMACOLOGY
id: eddda06c-9e7e-420e-8947-7e0f55f3f182
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The most widely accepted mechanism of action of sulfonamides in the Woods-Fildes theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, Sodium Sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS AND USAGE
id: 517d3d78-cd62-4e61-830f-fa557096db59
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
id: f2832aac-621f-4eef-83c3-fc2db1b335ba
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is not to be used by patients with kidney disease.
WARNINGS
id: 5bf89b46-389d-47db-8ba1-2a150a4f623e
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Although rare, sensitivity to Sodium Sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
ADVERSE REACTIONS
id: 206725a8-d9c9-4cc7-9df5-9f8de696c1b4
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Although rare, sodium sulfacetamide may cause local irritation.
DOSAGE AND ADMINISTRATION
id: 811e8cce-4ced-43d5-bf1d-e47d7f243b1b
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply Sodium Sulfacetamide 9% & Sulfur 4.5% Wash once or twice daily to affected areas or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a lather. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% & Sulfur 4.5% Wash sooner or using less often.
HOW SUPPLIED
id: 29082e36-4c07-4c4c-8357-1e6b389aafc4
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in in a 16 oz (454 g) bottle, NDC 54295-301-21.
PRINCIPAL DISPLAY PANEL – 454 g Bottle Label
id: b4ab1d24-0793-47c1-b09e-a33e6f59bfac
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 54295-301-21
Rx only
For topical use only
Not for ophthalmic use
Sodium
Sulfacetamide 9%
& Sulfur 4.5%
Wash
Trinity
Pharmaceuticals
Net WT. 16 oz. (454 g)
