SULFACETAMIDE SODIUM AND SULFUR cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Bi-Coastal Pharma International LLC

INN（国际名称）:

SULFACETAMIDE SODIUM

组成:

SULFACETAMIDE SODIUM 90 mg in 1 g

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Sulfacetamide sodium 9% and sulfur 4.5% wash is supplied in 16 oz (454 g) bottle NDC 42582-500-21 Store at 20°-25°C (68°-77°F), excursions permited between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however such exposure should be minimized. Protect from freezing.

授权状态:

unapproved drug other

产品特点

SULFACETAMIDE SODIUM AND SULFUR- SULFACETAMIDE SODIUM AND
SULFUR CREAM
BI-COASTAL PHARMA INTERNATIONAL 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% & SULFUR 4.5% WASH
DESCRIPTION
Sulfacetamide sodium is a sulfonamide with antibacterial activity
while sulfur acts as a
keratolytic agent. Chemically sulfacetamide sodium is
N-[(4-aminophenyl) sulfonyI]-
acetamide, monosodium salt, monohydrate. The structural formula is:
Each gram of sulfacetamide sodium USP 9% and sulfur USP 4.5% contains
90 mg of
Sodium Sulfacetamide USP and 45 mg of Sulfur USP in a cream
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, Xanthan
Gum.
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, sulfacetamide
sodium 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
Sulfacetamide sodium and sulfur wash is indicated in the topical
control of acne vulgaris,
acne rosacea and seborrheic dermati