Patient information: uses, side effects, how to take - Acanya
Do not use ONEXTON Gel if you have:
- had an allergic reaction to clindamycin, benzoyl peroxide, lincomycin, or any of the ingredients in ONEXTON Gel. See the end of this leaflet for a complete list of ingredients in ONEXTON Gel.
- Crohn’s disease or ulcerative colitis.
- had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use.
Talk with your doctor if you are not sure if you have any of the conditions listed above.
Before using ONEXTON Gel, tell your doctor about all of your medical conditions, including if you:
- plan to have surgery. ONEXTON Gel may affect how certain medicines work that may be given during surgery.
are pregnant or plan to become pregnant. It is not known if ONEXTON Gel will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ONEXTON Gel passes into your breast milk. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Talk to your doctor about the best way to feed your baby during treatment with ONEXTON Gel.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. ONEXTON Gel may affect the way other medicines work and other medicines may affect how ONEXTON Gel works.
- Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. ONEXTON Gel should not be used with products that contain erythromycin.
- Tell your doctor about any skin products you use. Other skin and topical acne products may increase the irritation of your skin when used with ONEXTON Gel.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I use ONEXTON Gel?
- Use ONEXTON Gel exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply ONEXTON Gel.
- Your doctor will tell you how long to use ONEXTON Gel.
- Apply ONEXTON Gel to your face 1 time each day.
Before you apply ONEXTON Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
What should I avoid while using ONEXTON Gel?
- Limit your time in sunlight. You should avoid using tanning beds or sun lamps during treatment with ONEXTON Gel. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and use sunscreen to cover the treated areas.
- Avoid getting ONEXTON Gel in your hair or on colored fabric. ONEXTON Gel may bleach hair or colored fabric.
What are possible side effects of ONEXTON Gel?
ONEXTON Gel can cause serious side effects including:
- Inflammation of the colon (colitis). Stop using ONEXTON Gel and call your doctor right away if you have severe stomach (abdominal) cramps watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with ONEXTON Gel.
- Allergic reactions. Stop using ONEXTON Gel, call your doctor and get help right away if you have any of the following symptoms during treatment with ONEXTON Gel:
- severe itching
- swelling of your face, eyes, lips, tongue or throat
- trouble breathing
The most common side effects of ONEXTON Gel include burning sensation, skin redness or swelling, itching and rash. Stop using ONEXTON Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away.
- These are not all of the possible side effects with ONEXTON Gel.
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 ONEXTON Gel?
- Store ONEXTON Gel at room temperature at or below 77°F (25°C).
- Do not freeze ONEXTON Gel.
- Throw away (discard) ONEXTON Gel 8 weeks after date of dispensing.
- Store pump upright.
- Keep the container tightly closed.
Keep ONEXTON Gel and all medicines out of the reach of children.
General information about the safe and effective use of ONEXTON Gel.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ONEXTON Gel for a condition for which it was not prescribed. Do not give ONEXTON Gel to other people, even if they have the same condition you have. It may harm them. You can also ask your doctor or pharmacist for information about ONEXTON Gel that is written for healthcare professionals.
What are the ingredients in ONEXTON Gel?
Active Ingredients: clindamycin phosphate and benzoyl peroxide
Inactive Ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water.
Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
Patented. See https://patents.ortho-dermatologics.com for US patent information.
ONEXTON is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2025 Bausch Health Companies Inc. or its affiliates
For more information about ONEXTON Gel, call 1-800-321-4576.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 07/2025 9432706 |
INSTRUCTIONS FOR USE
ONEXTON® (ON-EX-TUN)
(clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75%
Important Information: ONEXTON Gel is for use on skin only (topical use). ONEXTON Gel is not for use in your mouth, eyes or vagina.
Read this Instructions for Use before you start using ONEXTON Gel and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
- Apply ONEXTON Gel to your face 1 time each day as prescribed.
- Before you apply ONEXTON Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
- To apply ONEXTON Gel to your face, use the pump to dispense one pea-sized amount of ONEXTON Gel onto your fingertip. See Figure 1.
- One pea-sized amount of ONEXTON Gel should be enough to cover your entire face.
Figure 1
- Dot the one pea-sized amount of ONEXTON Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2.
Figure 2
- Spread the gel over your face and gently rub it in. It is important to spread the gel over your entire face. If your doctor tells you to put ONEXTON Gel on other areas of your skin with acne, be sure to ask how much you should use.
- Wash your hands with soap and water after applying ONEXTON Gel.
How should I store ONEXTON Gel?
- Store ONEXTON Gel at room temperature at or below 77°F (25°C).
- Do not freeze ONEXTON Gel.
- Throw away (discard) ONEXTON Gel 8 weeks after date of dispensing.
- Store pump upright.
- Keep the container tightly closed
Keep ONEXTON Gel and all medicines out of the reach of children.
Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
Patented. See https://patents.ortho-dermatologics.com for US patent information.
ONEXTON is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2025 Bausch Health Companies Inc. or its affiliates
This Instructions for Use has been approved by the
U.S. Food and Drug Administration. Revised: July 2025
9432706