SODIUM SULFACETAMIDE 10 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:

Acella Pharmaceuticals, LLC

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 10 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 have not been established.

Product summary:

HOW SUPPLIED:  Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12. Store at 15° - 25°C (59° - 77°F). Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER- SULFACETAMIDE SODIUM AND
SULFUR RINSE
ACELLA 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._
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SODIUM SULFACETAMIDE 10% - SULFUR 5% _CLEANSER_
RX ONLY
DESCRIPTION: Each mL of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
contains
100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation
containing
butylated hydroxytoluene, cetyl alcohol, disodium EDTA, glyceryl
stearate, PEG 100
stearate, magnesium aluminum silicate, methylparaben, propylparaben,
purified water,
sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium
thiosulfate, stearyl
alcohol, white petrolatum 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 not known, 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