SODIUM SULFACETAMIDE, SULFUR solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Exact-Rx, Inc.

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to be used by patients with kidney disease. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

Product summary:

HOW SUPPLIED: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is available in a 6 oz (170 g) tube, NDC 42808-0110-06 and 12 oz carton that contains (2) 6 oz tubes, NDC 42808-0110-12.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE, SULFUR- SODIUM SULFACETAMIDE, SULFUR SOLUTION
EXACT-RX, 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% AND SULFUR 5% CLEANSER
RX ONLY
DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial
activity while sulfur acts as
a keratolytic agent. Chemically sodium sulfacetamide is
N-[(4-aminophenyl)sulfonyl]-acetamide,
monosodium salt, monohydrate. The structural formula is:
Each gram contains sodium sulfacetamide 10% (100 mg) and sulfur 5% (50
mg), purified water,
disodium laureth sulfosuccinate and disodium lauryl sulfoacetate,
PPG-hydroxyethyl coco
isostearamide, sodium cocoyl isethionate, mineral oil, butylated
hydroxytoluene, emulsifying wax,
methyl paraben, propyl paraben, sodium thiosulfate, disodium EDTA and
hydrochloric acid.
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 5% Cleanser is
indicated in the topical control
of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is
contraindicated for
use by patients having known hypersensitivity to sulfonamides, sulfur
or any other component of this
preparation. Sodium Su