SODIUM SULFACETAMIDE 10% AND SULFUR 2% CLEANSER- sulfacetamide sodium, sulfur liquid

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Akron Pharma Inc.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is not to be used by patients with kidney disease.

leaflet_short:

SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is supplied in an 8 oz. (227 g) bottle, NDC 71399-0485-8.

מצב אישור:

unapproved drug other

מאפייני מוצר

SODIUM SULFACETAMIDE 10% AND SULFUR 2% CLEANSER- SULFACETAMIDE
SODIUM, SULFUR LIQUID
AKRON PHARMA 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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SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER
RX ONLY
DESCRIPTION
Each gram of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER (sodium
sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium
sulfacetamide
and 20 mg of colloidal sulfur in a mild aqueous based cleansing
vehicle containing aloe
vera gel, Ascorbic acid,cocamidopropyl betaine, cetyl alcohol,
disodium edetate, glyceryl
monostearate, lactic acid, magnesium aluminum silicate, methylparaben,
PEG-40
stearate, PEG -6 caprylic/capric glyceride,PEG-60 almond glyceride,
propylparaben,
propylene glycol,purified water, sodium thiosulfate, sodium lauryl
sulfate, stearyl alcohol,
and xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a
keratolytic agent. Sodium sulfacetamide is C8H9N2NaO 3S·H2O with
molecular weight of
254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide,
monosodium salt,
monohydrate.
The structural formula is:
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 10% - SULFUR 2% CLEANSER