INDICATION

XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if XACIATO is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

XACIATO is for intravaginal use only. Do not use in the eyes, mouth, or on your skin.

Do not use XACIATO if you are allergic to clindamycin or lincomycin.

Before using XACIATO, tell your healthcare provider about all of your medical conditions, including if you have an inflammatory bowel disease, or if you are pregnant or plan to become pregnant. It is not known if XACIATO will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with XACIATO. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

After you insert XACIATO, do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO. You should not use polyurethane condoms while taking XACIATO and for another 7 days after using it, since XACIATO may weaken the ability of polyurethane condoms and may not work well to prevent pregnancy or protect against Human Immunodeficiency Virus (HIV) and other sexually transmitted diseases (STDs). Latex or polyisoprene condoms should be used.

XACIATO may cause serious side effects, including diarrhea. If you have diarrhea after you use XACIATO, call your healthcare provider. One type of diarrhea is caused by a serious intestinal infection called Clostridioides difficile-associated diarrhea (CDAD), which may range from mild to colitis that can lead to death.

The most common side effects of XACIATO include yeast infection in your vagina that may require treatment with an antifungal medicine and vaginal discomfort, including itching, burning, redness, and dryness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XACIATO. For more information, ask your healthcare provider or pharmacist.