SODIUM SULFACETAMIDE AND SULFUR- sodium sulfacetamide and sulfur cream

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Rochester Pharmaceuticals

INN (Isem Internazzjonali):

SULFACETAMIDE SODIUM

Kompożizzjoni:

SULFACETAMIDE SODIUM 90 mg in 1 g

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 9% and 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% and Sulfur 4.5% Wash is not to be used by patients with kidney disease. Safety and effectiveness in children under the age of 12 has not been established.

Sommarju tal-prodott:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is available in a 16 oz. (454 g) bottle, NDC 49908-173-80. Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Rochester Pharmaceuticals Doylestown, PA 18901 1-866-458-1772 www.RochesterPharm.com SS9S45-PI-1015

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

SODIUM SULFACETAMIDE AND SULFUR- SODIUM SULFACETAMIDE AND SULFUR CREAM
ROCHESTER PHARMACEUTICALS
_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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DESCRIPTION
Rx Only
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash
Sodium sulfacetamide is a sulfonamide with anitbacterial activity
while sulfur acts as a keratolytic
agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)
sulfonyl]-acetamide, monosodium salt,
monohydrate. The chemical structure is:
Each gram of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash contains
90mg of sodium sulfacetamide
and 45mg 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, methyl
paraben, propyl paraben, purified water,
sodium cocoyl isethionate, sodium methyl cocyltaurate, sodium
thiosulfate, stearyl alcohol and 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,
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
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is indicated for the
topical control of acne vulgaris,
acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sodium Sulfacetamide 9% and Sulfur 4.5% Was