Label: PHEXX- lactic acid, l-, citric acid monohydrate, and potassium bitartrate gel

  • NDC Code(s): 69751-101-01, 69751-101-12
  • Packager: Evofem, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 23, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PHEXX® safely and effectively. See full prescribing information for PHEXX. PHEXX (lactic acid, citric acid, and potassium ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Limitations of Use - PHEXX is not effective for the ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - Administer one pre-filled applicator of PHEXX (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Vaginal gel: 18 mg of lactic acid, 10 mg of citric acid, and 4 mg of potassium bitartrate in each gram (1.8%, 1%, and 0.4%, respectively) of off-white to tan color gel supplied in a pre-filled ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cystitis and Pyelonephritis - Among 2804 subjects who received PHEXX in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [see Warnings and Precautions (5.1)] 6.1 Clinical Trials ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In ...
  • 11 DESCRIPTION
    PHEXX (lactic acid, citric acid, and potassium bitartrate) is a vaginal gel. PHEXX is an off-white to tan in color gel of uniform consistency, containing three active ingredients: lactic acid ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - In in vitro studies, PHEXX produced a normal vaginal pH range (pH 3.5 – 4.5) in the presence of semen. In clinical studies, post-coital testing demonstrated pH < 5 in ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term carcinogenicity studies have not been performed with PHEXX. Mutagenesis - Mutagenic studies have not ...
  • 14 CLINICAL STUDIES
    The efficacy of PHEXX for the prevention of pregnancy was evaluated in a multi-center, open-label, single-arm clinical trial in the United States (AMP002; NCT03243305). The study enrolled females ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    PHEXX (lactic acid, citric acid, and potassium bitartrate) vaginal gel is an off-white to tan color gel of uniform consistency containing lactic acid (1.8%), citric acid (1%), and potassium ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the Patient Information and FDA-approved patient labeling (Instructions for Use). Advise the patient: To intravaginally administer the contents of one pre-filled ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc. San Diego, CA 92130 - ©2024 Evofem, Inc. All rights reserved. U.S. Patents 6,706,276 and 10,568,855
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - PHEXX® (FEX ee) (lactic acid, citric acid, and potassium bitartrate) vaginal gel - For Vaginal Use Only - This Patient Information has been approved by the U.S. Food and ...
  • INSTRUCTIONS FOR USE
    PHEXX® (FEX) (lactic acid, citric acid, and potassium bitartrate) vaginal gel - For Vaginal Use Only - These Instructions for Use contain information on how to use PHEXX vaginal gel. Make sure ...
  • PRINCIPAL DISPLAY PANEL - 12 Applicator Box
    phexx® (lactic acid, citric acid, and - potassium bitartrate) Vaginal Gel - 1.8%, 1%, 0.4% NDC 69751-101-12 - PN-XXXX RXX
  • INGREDIENTS AND APPEARANCE
    Product Information