Sodium Sulfacetamide 10% Sulfur 2% Cream

DESCRIPTION:

id: 620baf55-495c-b099-e053-2a91aa0a8566
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) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each gram of Sodium Sulfacetamide 10% Sulfur 2% Cream contains 100 mg of Sodium Sulfacetamide and 20 mg of Sulfur
in a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum.

CLINICAL PHARMACOLOGY:

id: 620baf55-495d-b099-e053-2a91aa0a8566
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Sodium Sulfacetamide exhibits antibacterial activity. It is believed to block
bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorption
through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied
sulfur is absorbed. Although the exact mode of the keralytic activity of sulfur is unknown, it is reported to result
from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur
has been reported to inhibit
P. acnes, thereby reducing the associated inflammation.

INDICATIONS:

id: 620baf55-495e-b099-e053-2a91aa0a8566
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne
rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

id: 620baf55-495f-b099-e053-2a91aa0a8566
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated foruse by patients having known
hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2%
Cream is not to be used by patients with kidney disease.

WARNINGS:

id: 620baf55-4960-b099-e053-2a91aa0a8566
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Although rare, sensitivity to sodium sulfacetaminde 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.

ADVERSE REACTIONS:

id: 620baf55-4968-b099-e053-2a91aa0a8566
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:

id: 620baf55-4969-b099-e053-2a91aa0a8566
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.

HOW SUPPLIED:

id: 620baf55-496a-b099-e053-2a91aa0a8566
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) tubes, NDC 42192-150-02.

PRINCIPAL DISPLAY PANEL – 57 g Tube Label

id: 620baf55-496e-b099-e053-2a91aa0a8566
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 42192-150-02 Rx Only Sulfacetamide Sodium 10%

Sulfur 2% Cream
Net wt. 2 oz (57 g) Acella

PHARMACEUTICALS, LLC