AVAR LS- sulfacetamide sodium, sulfur emulsion

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:

Mission Pharmacal Company

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): 8 oz. (227 g) bottles, NDC 0178-0475-08 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 L667508R0222

Authorization status:

unapproved drug other

Summary of Product characteristics

AVAR LS- SULFACETAMIDE SODIUM, SULFUR EMULSION
MISSION PHARMACAL COMPANY
_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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AVAR LS CLEANSER (SODIUM SULFACETAMIDE 10% AND SULFUR 2%)
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide and 20 mg of
colloidal sulfur in a
vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance,
glyceryl stearate (and)
PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol,
propylene glycol,
purified water, sodium lauryl sulfate, sodium magnesium silicate,
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: Streptococci,
Staphylococci