SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER- sulfacetamide sodium and sulfur rinse

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:

Gabar Health Sciences Corp.

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.

Product summary:

HOW SUPPLIED Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is supplied in an 6oz. (170g) bottle (NDC 82429-107-06), 8oz. (227g) bottle (NDC 82429-107-08) and 12oz. (340g) bottle (NDC 82429-107-12) . Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 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 bottle 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 by: Gabar Health Sciences, Corp Atlanta, GA 30354 USA Rev 04/23

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER- SULFACETAMIDE
SODIUM AND SULFUR RINSE
GABAR HEALTH SCIENCES CORP.
_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: Each gram of Sodium Sulfacetamide and Sulfur (sodium
sulfacetamide
10% w/w and sulfur 5% w/w) contains 100 mg of sodium sulfacetamide and
50 mg of
colloidal sulfur in a vehicle consisting of: aloe vera leaf extract,
butylated hydroxytoluene,
cetyl alcohol, disodium oleamido monoethanolamine 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, xanthan
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 Propionibacterium acnes and
the formation of
free fatty acids.
INDICATIONS:
Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is indicate