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How to use XACIATO

For vaginal use only. Do not use it in the eyes or mouth, or on your skin.

Read these Instructions for Use before you use XACIATO and each time you get a refill as there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Instructions Below

IMPORTANT INFORMATION

  • Use XACIATO exactly as your healthcare provider tells you to use it.
  • Use 1 filled applicator of XACIATO gel in your vagina.
  • Do not use any medicine from the tube or applicator more than 1 time. The XACIATO gel is for 1 time (single-use) only.
  • Do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with XACIATO gel and for 3 days after using XACIATO gel.
  • Do not use polyurethane condoms during treatment with XACIATO gel and for 7 days after using XACIATO gel. XACIATO gel may weaken polyurethane condoms. Latex or polyisoprene condoms should be used.
  • If you have questions or if your vaginal symptoms do not go away, contact your healthcare provider.

How do I store XACIATO?

  • Store XACIATO gel at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not store in the refrigerator or freezer.

Store XACIATO gel and all medicines out of the reach of children.

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Instructions for Use

You will need the following included supplies (see Figure A):

  • 1 single use tube containing the XACIATO gel
  • 1 empty applicator, to fill and deliver the single dose of medicine
Download Instructions for Use
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Step 1. Remove the applicator and tube from the container box.

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Step 2. Open the tube.

  • Unscrew the cap from the tube (see Figure B1).
  • Puncture the seal on the tube using the pointed tip on the cap by pushing the cap straight onto the tube (see Figure B2).
  • Do not use the tube if it looks like it has been opened before.
  • Do not use the tube if the seal is damaged or broken.
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Step 3. Fill the applicator.

  • While holding the applicator by the grip, screw the tip of the applicator (other end from the grip) onto the tube until it feels secure (see Figure C1).
  • Leave the plunger inside the applicator.
  • Squeeze the tube from the bottom to push the XACIATO gel into the applicator (see Figure C2).
  • The XACIATO gel will push the plunger up as the applicator fills (see Figure C3).
  • Continue to fill the applicator until you see the black line on the plunger outside the applicator (see Figure C4).
  • Unscrew the filled applicator from the tube.
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Step 4. Prepare to insert the filled applicator.

Lie on your back with your knees bent or in any comfortable position (see Figure D).

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Step 5. Insert the filled applicator.

Hold the filled applicator by the grip and gently insert the tip of the applicator into your vagina as far as it will comfortably go (see Figure E).

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Step 6. Push the plunger.

While holding the applicator in place, slowly push the plunger until it stops, to release all the XACIATO gel into your vagina (see Figure F).

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Step 7. Remove the empty applicator from your vagina.

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Step 8. Place the used applicator and tube in the container box and throw away (dispose of) in your household trash.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Please read the accompanying Patient Information and Instructions for Use for XACIATO and discuss them with your healthcare provider. The physician Prescribing Information also is available.