SULFACLEANSE 8/4- sodium sulfacetamide and sulfur lotion

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

PruGen, Inc.

INN (nume internaţional):

SULFACETAMIDE SODIUM

Compoziție:

SULFACETAMIDE SODIUM 80 mg in 1 mL

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is not to be used by patients with kidney disease.

Rezumat produs:

SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is available in a 16 fl. oz. (473 mL) bottle, NDC 42546-175-16. 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.

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

SULFACLEANSE 8/4 - SODIUM SULFACETAMIDE AND SULFUR LOTION
PRUGEN, INC.
_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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SULFACLEANSE
/
(SODIUM SULFACETAMIDE 8% & SULFUR 4%)
RX ONLY
Topical Suspension in a vehicle containing Green Tea and Aloe
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 mL of SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE 8% & SULFUR 4%)
contains
80 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation
consisting of: aloe
barbadensis gel, butylated hydroxytoluene, cetyl alcohol, disodium
oleamido MEA
sulfosuccinate, edetate disodium, glyceryl stearate, green tea
extract, magnesium
aluminum silicate, methylparaben, PEG-100 stearate, petrolatum,
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
paraaminobenzoic 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
® 8
4
®
®
SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE 8% & SULFUR 4%) is indicated
for the
topical control of acne vulgaris, acne rosacea