SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER- sulfacetamide sodium, sulfur liquid

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:

Akron Pharma Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. SODIUM SULFACETAMIDE 9.8% - 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% - SULFUR 4.8% CLEANSER is not to be used by patients with kidney disease.

Product summary:

SODIUM SULFACETAMIDE 9.8% - SULFUR 4.8% CLEANSER is supplied in an 10oz. (285 g) bottle, NDC 71399-0486-1

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% CLEANSER- SULFACETAMIDE
SODIUM, SULFUR LIQUID
AKRON PHARMA 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 9.8% - SULFUR 4.8% CLEANSER
RX ONLY
DESCRIPTION
Each gram of Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser contains
98 mg of
Sodium Sulfacetamide and 48 mg of Sulfur in a formulation containing
aloe vera
gel,butylated hydroxytoluene, cetyl alcohol, disodium edetate,
glyceryl monostearate,
magnesium aluminum silicate, methylparaben, PEG-40 stearate, PEG -6
caprylic/capric
glyceride,PEG-60 almond glyceride, propylparaben, propylene
glycol,purified water,
sodium thiosulfate, sodium lauryl sulfate, stearyl alcohol, and
xanthan gum
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:
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 9.8% - 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% - SULFUR