ROSANIL - sodium sulfacetamide, sulfer solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Galderma Laboratories, L.P.

INN (Διεθνής Όνομα):

Sulfacetamide

Σύνθεση:

Sulfacetamide 10 g in 100 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

ROSANIL® Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. ROSANIL® Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. ROSANIL® Cleanser is not to be used by patients with kidney disease.

Περίληψη προϊόντος:

ROSANIL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser is available in a 6 oz tube. NDC 0299-3839-06 Store at controlled room temperature 20° - 25°C (68° - 77°F). Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA GALDERMA is a registered trademark. www.rosanil.com 325076-0706 Revised: July 2006

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

ROSANIL - SODIUM SULFACETAMIDE, SULFER SOLUTION
GALDERMA LABORATORIES, L.P.
_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._
----------
ROSANIL® CLEANSER
(SODIUM SULFACETAMIDE 10% AND SULFUR 5%)
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 ROSANIL (sodium sulfacetamide 10% and sulfur 5%) Cleanser
contains: ACTIVE:
sodium sulfacetamide 10% (100 mg), sulfur 5% (50 mg). INACTIVE:
butylated hydroxytoluene, edetate
disodium, emulsifying wax, hydrochloric acid, light mineral oil,
methylparaben, PPG-2 hydroxyethyl
coco/isostearamide, propylparaben, purified water, sodium cocoyl
isethionate, sodium lauryl
sulfoacetate (and) disodium laureth sulfosuccinate, and sodium
thiosulfate.
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:
ROSANIL Cleanser is indicated in the topical control of acne vulgaris,
acne rosacea and seborrheic
dermatitis.
CONTRAINDICATIONS:
ROSANIL Cleanser is contraindicated for use by patients having known
hypersensitivity to
sulfonamides, sulfur or any other comp