Xaciato

What is Xaciato?

Xaciato is an antibacterial gel used to treat bacterial vaginosis in female patients 12 years of age and older.

What is the most important information I should know about Xaciato?

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

How should I use Xaciato?

• Read and follow the Instructions for Use that come with Xaciato.

How should I store Xaciato?

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

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

What are the ingredients in Xaciato?

Active ingredient: clindamycin phosphate

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

Instructions for use for Xaciato

Xaciato [zah-she-AH-toe]

(clindamycin phosphate vaginal gel 2%)

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° to 77°F (20° to 25°C).
• Do not store in the refrigerator or freezer.

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

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.
Step 1. Remove the applicator and tube from the container box.
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.
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 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.
Step 4. Prepare to insert the filled applicator. Lie on your back with your knees bent or in any comfortable position (see Figure D).
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).
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).
Step 7. Remove the empty applicator from your vagina.
Step 8. Place the used applicator and tube in the container box and throw away (dispose of) in your household trash.

Instructions for use approved 12/2021