SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH- sulfacetamide sodium and sulfur rinse

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5), Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)

Dostupno od:

Trinity Pharmaceuticals, LLC

INN (International ime):

Sulfacetamide Sodium

Sastav:

Sulfacetamide Sodium 9 mg in 1 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. 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.

Proizvod sažetak:

Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in in a 16 oz (454 g) bottle, NDC 54295-301-21. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Status autorizacije:

unapproved drug other

Svojstava lijeka

SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH - SULFACETAMIDE SODIUM AND
SULFUR RINSE
TRINITY 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._
----------
SODIUM
SULFACETAMIDE 9%
& SULFUR 4.5%
WASH
RX ONLY
DESCRIPTION
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
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
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical
control of acne
vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sodium Sulfacetamide 9% &