SODIUM SULFACETAMIDE shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Available from:

BioComp Pharma, Inc.

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). 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 fl. oz. (237 mL) bottles, NDC 44523-510-08 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 L71008R0121

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE- SODIUM SULFACETAMIDE SHAMPOO
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% SHAMPOO
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide in a vehicle
consisting of: citric
acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl
tetrastearate
(and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond
glycerides, propylene
glycol, propylparaben, purified water, sodium chloride, and sodium
laureth sulfate (and)
cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate.
Sodium sulfacetamide is a sulfonamide with antibacterial activity.
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, E.
coli, Klebsiella pneumoni