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Xaciato (Clindamycin phosphate): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
100 mg/5 g
Other brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Xaciato

What is XACIATO?

  • 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.

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 inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

  • 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.

  • are breastfeeding or plan to breastfeed. The amount of XACIATO which passes into your breast milk is low and is not expected to harm your baby. Talk with your healthcare provider about the best way to feed your baby while using XACIATO.

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

How should I use XACIATO?

  • Use XACIATO exactly as your healthcare provider tells you to use it.
  • Use 1 filled applicator of XACIATO in the vagina.
  • Do not use any medicine from the tube or applicator more than 1 time. XACIATO is for 1 time (single-use) only.
  • Do not use in the eyes, mouth, or on your skin.
  • See the Instructions for Use at the end of this Patient Information leaflet for more information about how to fill the applicator and use XACIATO.

What should I avoid while using XACIATO?

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 during treatment with XACIATO and for 7 days after using XACIATO. XACIATO may weaken polyurethane condoms and they may not work well for preventing pregnancy or protecting against Human Immunodeficiency Virus (HIV) and other sexually transmitted diseases (STDs). Latex or polyisoprene condoms should be used.

What are the possible side effects of XACIATO?

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

The most common side effects of XACIATO include:

  • Yeast infection in your vagina that may require treatment with an antifungal medicine.
  • 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XACIATO?

  • Store XACIATO at room temperature between 68ºF and 77ºF (20ºC to 25ºC).

Keep XACIATO and all medicines out of the reach of children.

General information about the safe and effective use of XACIATO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XACIATO for a condition for which it was not prescribed. Do not give XACIATO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XACIATO that is written for health professionals.

What are the ingredients in XACIATO?

Active ingredient: clindamycin phosphate

Inactive ingredients: benzyl alcohol, citric acid monohydrate or citric acid anhydrous, poloxamer 407, purified water, sodium citrate dihydrate and xanthan gum.

Distributed by: Organon LLC, a subsidiary of

ORGANON & Co.,

Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

© 2025 Organon group of companies. All rights reserved.

For more information, go to www.xaciato.com or call 1-844-674-3200

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This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215650 · View the label on DailyMed

Revision date stated in the text: December 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Xaciato

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Lincosamide Antibacterial
Active ingredient Clindamycin phosphate 100 mg/5 g
Dosage form Gel
Route Vaginal
Marketing status listed in the FDA NDC Directory
Company (applicant) ORGANON LLC
FDA approval NDA 215650New Drug Application (NDA) Approved December 7, 2021
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/5 g – 8 g in 1 tube / 1 in 1 carton NDC 78206-189-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.