SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM- sulfacetamide sodium and sulfur cream

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

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated foruse by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2% Cream 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.

Přehled produktů:

Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) tubes, NDC 42192-150-02. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature] 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.

Stav Autorizace:

unapproved drug other

Charakteristika produktu

SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM- SULFACETAMIDE SODIUM AND
SULFUR CREAM
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 2% CREAM
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 gram of Sodium Sulfacetamide 10% Sulfur 2% Cream contains 100 mg
of Sodium
Sulfacetamide and 20 mg of Sulfur in a base containing BHT,
Ceteareth-20, Cetearyl
Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate,
Ethylparaben, Fragrance,
Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene
Glycol,
Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum.
CLINICAL PHARMACOLOGY:
Sodium Sulfacetamide exhibits antibacterial activity. It is believed
to block bacterial
growth by acting as a competitive antagonist of para-aminobenzoic acid
(PABA). While
absorption through intact skin has not been determined for sodium
sulfacetamide, it is
estimated that 1% of topically applied sulfur is absorbed. Although
the exact mode of
the keralytic activity of sulfur is unknown, it is reported to result
from the interaction of
sulfur with the cysteine content of keratinocytes. In combination with
sulfacetamide,
sulfur has been reported to inhibit _P. acnes_, thereby reducing the
associated
inflammation.
INDICATIONS:
Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical
control of acne
vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS:
Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated foruse by
patients
having known hypersensitivity to sulfonamides, sulfur or any other
component of this
preparation. Sodium Sulfacetamide 10% Sulfur 2% Cream is not to be
used by p