lactic acid, L-, citric acid monohydrate, and potassium bitartrate

FDA Drug Profile — Phexxi, Phexx

Drug Details

Generic Name
lactic acid, L-, citric acid monohydrate, and potassium bitartrate
Brand Names
Phexxi, Phexx
Application Number
NDA208352
Sponsor
Evofem, Inc.
NDC Codes
2
Dosage Forms
GEL
Routes
VAGINAL
Active Ingredients
CITRIC ACID MONOHYDRATE, LACTIC ACID, L-, POTASSIUM BITARTRATE

Indications and Usage

1 INDICATIONS AND USAGE PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXXI is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. ( 1 ) Limitations of Use: PHEXXI is not effective for the prevention of pregnancy when administered after intercourse. Limitations of Use PHEXXI is not effective for the prevention of pregnancy when administered after intercourse [see Dosage and Administration (2.1) ].