FDA Label for Propofol 1%
View Indications, Usage & Precautions
Propofol 1% Product Label
The following document was submitted to the FDA by the labeler of this product Genixus. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Propofol injectable emulsion, USP is a sterile, nonpyrogenic white or almost white, homogeneous
emulsion, containing 10 mg/mL of propofol, USP suitable for intravenous administration. Propofol,
USP is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.27.
The structural formula is:
Propofol, USP is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion.
The pKa is 11. The octanol/water partition coefficient for propofol, USP is 6761:1 at a pH of 4.5 to
7.4. In addition to the active component, propofol, USP the formulation also contains
soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg phospholipids (12 mg/mL); and benzyl alcohol
(0.15%); with sodium hydroxide to adjust pH. Propofol injectable emulsion, USP is isotonic and has
a pH of 5.5 to 7.4.
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