SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS- sodium sulfacetamide, sulfur swab

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Acella Pharmaceuticals, LLC

INN (Mezinárodní Name):

SULFACETAMIDE SODIUM

Složení:

SULFACETAMIDE SODIUM 10 g in 100 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are 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.

Přehled produktů:

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are available in boxes of 60 cloths (3.7 g), (NDC 42192-113-60). Store at controlled room temperature, 15° - 25° (59° - 77°F). All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. 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, incipients, inactive ingredients and chemical formulation information provided herein.

Stav Autorizace:

unapproved drug other

Charakteristika produktu

SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS- SODIUM SULFACETAMIDE,
SULFUR SWAB
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 4% CLEANSING PADS IN A VEHICLE
CONTAINING GREEN TEA AND
ALOE 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 pad of Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are
coated with a cleanser-based
formulation. Each gram of this cleanser-based
formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of
Sulfur. The cleanser base consists
of: purified water, sodium cocoyl isethionate
disodium oleamido MEA sulfosuccinate, green tea extract, cetyl
alcohol, stearyl alcohol, glycerol
stearate and PEG 100 stearate methyl paraben, propyl
paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate,
disodium EDTA, magnesium
aluminum silicate, xanthan gum, sodium methyl cocoyl
taurate, white petrolatum.
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% -