SUMAXIN WASH- sulfacetamide sodium and sulfur lotion

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:

Medimetriks Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is not to be used by patients with kidney disease.

Product summary:

Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is available in a 16 oz (454 g) bottle, NDC 43538-130-16. Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

SUMAXIN WASH- SULFACETAMIDE SODIUM AND SULFUR LOTION
MEDIMETRIKS PHARMACEUTICALS, 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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SUMAXIN
(SODIUM SULFACETAMIDE 9% & SULFUR 4%)
WASH
R ONLY
In a vehicle containing Green Tea & Aloe
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 mg of SUMAXIN (SODIUM SULFACETAMIDE 9% & SULFUR 4%) WASH contains
90 mg of sodium
sulfacetamide and 40 mg of sulfur in a formulation consisting of:
aloe, butylated hydroxytoluene, cetyl
alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium,
fragrance, glyceryl stearate/PEG-
100 stearate, green tea, magnesium aluminum silicate, methylparaben,
propylparaben, purified water,
sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium
thiosulfate, stearyl alcohol, xanthan
gum.
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
SUMAXIN (SODIUM SULFACETAMIDE 9% & SULFUR 4%) WASH is indicated for
the topical control of
acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
SUMAXIN (SO