BP Cleansing Wash (Sodium Sulfacetamide 10% and Sulfur 4%) In a Urea Vehicle

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 100 mg in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

INDICATIONS: BP Cleansing Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: BP Cleansing Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. BP Cleansing Wash is not to be used by patients with kidney disease. Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

Περίληψη προϊόντος:

HOW SUPPLIED: BP Cleansing Wash is available in a 16 fl. oz. (473 mL) bottle, NDC 42192-103-16. Store BP Cleansing Wash at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

BP CLEANSING WASH- SODIUM SULFACETAMIDE AND SULFUR LIQUID
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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BP CLEANSING WASH
(SODIUM SULFACETAMIDE 10% AND SULFUR 4%)
IN A UREA VEHICLE
DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial
activity. 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 Sodium Sulfacetamide 10% and Sulfur 4% contains 100 mg of
sodium sulfacetamide and 40
mg of sulfur in an emulsion base containing urea 10%, butylated
hydroxytoluene, cetyl alcohol,
disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate
and PEG 100 stearate,
magnesium aluminum silicate, methylparaben, propylparaben, purified
water, sodium cocoyl isethionate,
sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol,
white petrolatum 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: BP Cleansing Wash is indicated in the topical control of
acne vulgaris, acne rosacea
and seborrheic dermatitis.
CONTRAINDICATIONS: BP Cleansing Wash is contraindicated for use by
patients having known
hypersens