SODIUM SULFACETAMIDE AND SULFUR solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Seton Pharmaceuticals

INN (שם בינלאומי):

Sulfacetamide

הרכב:

Sulfacetamide 100 mg in 1 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is contraindicated for patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is not to be used by patients with kidney disease.

leaflet_short:

10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is available in a 12 oz. (355 mL) bottle, NDC 13925-161-12. Store 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) at 15°-25° C (59°-77° F). Protect from freezing. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence. Manufactured for: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Iss. 5/11

מצב אישור:

unapproved drug other

מאפייני מוצר

SODIUM SULFACETAMIDE AND SULFUR- SODIUM SULFACETAMIDE AND SULFUR
SOLUTION
SETON 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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10% SODIUM SULFACETAMIDE
5% SULFUR CLEANSER (IN A UREA VEHICLE)
RX ONLY
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 10% SODIUM SULFACETAMIDE 5% SULFUR CLEANSER (IN A UREA
VEHICLE) contains 100 mg of
sodium sulfacetamide and 50 mg of sulfur in an emulsion base
containing 10% Urea, butylated
hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA
sulfosuccinate, fragrance,
glyceryl stearate and PEG 100 stearate, magnesium aluminum silicate,
methylparaben, propylparaben,
purified water, sodium cocoyl isethionate, sodium methyl cocoyl
taurate, 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:
10% SODIUM SULFACETAMIDE 5% SULFUR CLEANSER (IN A UREA VEHICLE) is
indicated in the topical
control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS:
10% SODI