SODIUM SULFACETAMIDE AND SULFUR CLEANSER- sulfacetamide sodium and sulfur cream

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bi-Coastal Pharma International LLC

INN (nemzetközi neve):

SULFACETAMIDE SODIUM

Összetétel:

SULFACETAMIDE SODIUM 100 mg in 1 g

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 10% and 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% and Sulfur 2% Cleanser is not to be used by patients with kidney disease.

Termék összefoglaló:

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 42582-800-08. Store at 25°C (77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep tube or packet tightly closed. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

Engedélyezési státusz:

unapproved drug other

Termékjellemzők

SODIUM SULFACETAMIDE AND SULFUR CLEANSER- SULFACETAMIDE SODIUM AND
SULFUR CREAM
BI-COASTAL PHARMA INTERNATIONAL 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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SODIUM SULFACETAMIDE 10%
AND SULFUR 2% CLEANSER
(SODIUM SULFACETAMIDE 10%, SULFUR 2%)
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10%
w/w and
sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of
colloidal sulfur in
a vehicle consisting of: aloe barbadensis (aloe vera) leaf extract,
butylated
hydroxytoluene, camellia oleifera (green tea) leaf extract, cetyl
alcohol, disodium
oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin,
glyceryl
monostearate, magnesium aluminum silicate, methylparaben, PEG-100
stearate,
propylparaben, purified water, sodium cocoyl isethionate, sodium
methyl cocoyl taurate,
sodium thiosulfate, stearyl alcohol, xantham gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a
keratolytic agent. Sodium sulfacetamide is C H N NaO S∙H O 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.
8
9
2
3
2
The exact mode of action of sulfur in the treatment of acne is
unknown, but it has been
reported that it inhibits t