Functional Category
Antimicrobial preservative; disinfectant.
Applications in Pharmaceutical Formulation
Phenoxyethanol is an antimicrobial preservative used in cosmetics and topical pharmaceutical formulations at a concentration of 0.5–1.0%; it may also be used as a preservative and antimicrobial agent for vaccines.(1,2) Therapeutically, a 2.2% solution or 2.0% cream has been used as a disinfectant for superficial wounds, burns, and minor infections of the skin and mucous membranes.(3–5) Phenoxyethanol has a narrow spectrum of activity and is thus frequently used in combination with other preservatives, see Section 10
Description
Phenoxyethanol is a colorless, slightly viscous liquid with a faint pleasant odor and burning taste
Stability and Storage Conditions
Aqueous phenoxyethanol solutions are stable and may be sterilized by autoclaving. The bulk material is also stable and should be stored in a well-closed container in a cool, dry place.
Incompatibilities
The antimicrobial activity of phenoxyethanol may be reduced by interaction with nonionic surfactants and possibly by absorption by polyvinyl chloride.(14) The antimicrobial activity of phenoxyethanol against Pseudomonas aeruginosa may be reduced in the presence of cellulose derivatives (methylcellulose, sodium carboxymethylcellulose, and hypromellose (hydroxypropylmethylcellulose)).(15)
Safety
Phenoxyethanol produces a local anesthetic effect on the lips, tongue, and other mucous membranes. The pure material is a moderate irritant to the skin and eyes. In animal studies, a 10% v/v solution was not irritant to rabbit skin and a 2% v/v solution was not irritant to the rabbit eye.(10) Long-term exposure to phenoxyethanol may result in CNS toxic effects similar to other organic solvents.(16) Safety issues related to preservatives used in vaccines, including 2-phenoxyethanol have been reviewed.(17) Contact urticaria has been reported upon exposure to 2-phenoxyethanolcontaining cosmetics.(18) The US FDA has recommended avoiding at least one topical product containing phenoxyethanol due to concerns over inadvertant exposure to nursing infants.(19) LD50 (rabbit, skin): 5 g/kg(20) LD50 (rat, oral): 1.26 g/kg(12)