SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium, sulfur suspension

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:

BioComp Pharma, Inc.

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Product summary:

This product is supplied in the following size(s): 30 g bottles, NDC 44523-604-01 To report a serious adverse event or obtain product information, call 1-866-762-2365. Manufactured for: BIOCOMP PHARMA ® , INC. San Antonio, TX 78230 1355 L60401R1221

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE, SULFUR- SULFACETAMIDE SODIUM, SULFUR SUSPENSION
BIOCOMP 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 10% AND SULFUR 5% SUSPENSION
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide and 50 mg of
colloidal sulfur in a vehicle
consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA,
fragrance, glyceryl stearate (and) PEG-
100 stearate, magnesium aluminum silicate, PEG-150 distearate,
phenoxyethanol, polyethylene glycol
400, purified water, sodium lauryl sulfate, sodium thiosulfate,
stearyl alcohol and xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a keratolytic
agent. Sodium sulfacetamide is C
H
N
NaO
S·H
O with molecular weight of 254.24. Chemically,
sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide,
monosodium salt, monohydrate. The
structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a
bitter taste. It is freely soluble in
water, sparingly soluble in alcohol, while practically insoluble in
benzene, in chloroform and in ether.
CLINICAL PHARMACOLOGY:
Sodium sulfacetamide exerts a bacteriostatic effect against
sulfonamide sensitive Gram-positive and
Gram-negative microorganisms commonly isolated from secondary
cutaneous pyogenic infections. It
acts by restricting the synthesis of folic acid required by bacteria
for growth, by its competition with
para-aminobenzoic acid. There is no clinical data available on the
degree and rate of systemic
absorption of this product when applied to the skin or scalp. However,
significant absorption of sodium
sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance
is unknown. Organisms that show
susceptibility to sodium sulfacetamide are: Stre