SODIUM SULFACETAMIDE 9.8%, SULFUR 4.8%- sodium sulfacetamide, sulfur solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Noble Pharmaceuticals, LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

INDICATIONS: Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.

Dettagli prodotto:

HOW SUPPLIED: Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is supplied in an 10 oz. (285 g) bottle, NDC 70156-109-10. Store at 20°C to 25°C (67°F to 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. Manufactured for: Noble Pharmaceuticals LLC Cooper City, FL 33024 USA 4/17

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SODIUM SULFACETAMIDE 9.8%, SULFUR 4.8%- SODIUM SULFACETAMIDE,
SULFUR SOLUTION
NOBLE 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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SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER
(SODIUM SULFACETAMIDE 9.8%, SULFUR 4.8%)
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION: Each gram of Sodium Sulfacetamide and Sulfur (sodium
sulfacetamide
9.8% w/w and sulfur 4.8% w/w) contains 98 mg of sodium sulfacetamide
and 48 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.
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