SULFACETAMIDE SODIUM, SULFUR lotion

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Trinity Pharmaceuticals, LLC

INN (الاسم الدولي):

SULFACETAMIDE SODIUM

تركيب:

SULFACETAMIDE SODIUM 100 mg in 1 g

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

INDICATIONS: Sulfacetamide sodium and sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: Sulfacetamide sodium and sulfur cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide sodium and sulfur cleanser is not to be used by patients with kidney disease. Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

ملخص المنتج:

HOW SUPPLIED: Sulfacetamide sodium 10% and sulfur 5% cleanser is supplied in 6 oz (170 g) tube      NDC 54295-307-23 2 x 6 oz (170 g) tubes NDC 54295-307-20 Store at 20°-25°C (68°-77°F), excursions permited between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however such exposure should be minimized. 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 MEDICATIONS OUT OF THE REACH OF CHILDREN Rx Only Marketed by: Trinity Pharmaceuticals, LLC 1 International Plaza, Suite 550 Philadelphia, PA 19113 TrinityPharmaLLC.com

الوضع إذن:

unapproved drug other

خصائص المنتج

SULFACETAMIDE SODIUM, SULFUR - SULFACETAMIDE SODIUM, SULFUR LOTION
TRINITY 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._
----------
DESCRIPTION:
Sulfacetamide sodium is a sulfonamide with antibacterial activity
while sulfur acts as a keratolytic
agent. Chemically sulfacetamide sodium is N-[(4-aminophenyl)
sulfonyI]-acetamide, monosodium salt,
monohydrate. The structural formula is:
Each gram of sulfacetamide sodium 10% and sulfur 5% contains 100 mg of
Sodium Sulfacetamide USP
and 50 mg of Sulfur USP in a cream containing: Benzyl Alcohol,
Emulsifying Wax, Hamaelis virginiana
(Witch Hazel) Distillate, Kaolin, Propanediol, Propylene Glycol,
Purified Water, Quillaja (Quillaia)
saponaria Extract, Silicon Dioxide, 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,
sulfacetamide sodium 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:
Sulfacetamide sodium and sulfur cleanser is indicated in the topical
control of acne vulgaris, acne
rosacea and seborrheic dermatitis.
CONTRAINDICATIONS:
Sulfacetamide sodium and sulfur cleanser is contraindicated for use by
patients having known
hypersensitivity to sulfonamides, sulfur or any other component of
this preparation. Sulfacetamide
sodium and sulfur cleanser is not to be used by patients