SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER- sulfacetamide sodium, sulfur liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)

Available from:

Acella Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.

Product summary:

Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is supplied in a 10 oz (285 g) bottle (NDC 42192-156-10).

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER- SULFACETAMIDE
SODIUM, SULFUR LIQUID
ACELLA PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER
RX ONLY
DESCRIPTION
Each gram of Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser contains
98 mg of
Sodium Sulfacetamide and 48 mg of Sulfur in a formulation containing
Aloe Barbadensis
(Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera
(Green Tea) Leaf
Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate
Disodium,
Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum
Silicate,
Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium
Cocoyl
Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl
Alcohol and
Xanthan Gum.
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:
CLINICAL PHARMACOLOGY
The most widely accepted mechanism of action of sulfonamides is 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
not known, but it
has been reported that it inhibits the growth of Propionibacterium
acnes and the
formation of free fatty acids.
INDICATIONS
Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is indicated in the
topical control of
acne vulgaris