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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Acella Pharmaceuticals, LLC

INN (Διεθνής Όνομα):

SULFACETAMIDE SODIUM

Σύνθεση:

SULFACETAMIDE SODIUM 9 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

INDICATIONS: 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% - Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is not to be used by patients with kidney disease.

Περίληψη προϊόντος:

HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is available in 16 oz (454 g) bottles, NDC 42192-144-16. 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.

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH- SULFACETAMIDE SODIUM AND
SULFUR RINSE
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% - SULFUR 4.5% WASH
IN A VEHICLE CONTAINING GREEN TEA AND ALOE
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) sulfonyl]-
acetamide, monosodium salt, monohydrate. The structural formula is:
Each gram of Sodium Sulfacetamide 9% - Sulfur 4% Wash contains 90 mg
of Sodium
Sulfacetamide and 45 mg of Sulfur in a formulation containing:
purified water, sodium
cocoyl isethionate, magnesium aluminum silicate, disodium oleamido MEA
sulfosuccinate,
sodium methyl cocoyl taurate, glyceryl stearate (and) PEG-100
stearate, stearyl alcohol,
cetyl alcohol, methyl paraben, propyl paraben, butylated
hydroxytoluene, xanthan gum,
sodium thiosulfate, green tea extract, aloe vera, disodium EDTA, and
fragrance.
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% - Sulfur 4.5% Wash is indicated
in the topical
control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAI