Important Safety Information AND INDICATION

Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn’s disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use.

Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin.

What should I avoid while using CABTREO?

• Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight.
• Cold weather and wind may irritate skin treated with CABTREO.
• Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema.
• Avoid skin products that may dry or irritate your skin.
• Avoid the use of "waxing" as a hair removal method on skin treated with CABTREO.

What are the possible serious and most common side effects of CABTREO?

Tell your doctor right away if you experience side effects, including:

• Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded.
• Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO.
• Sensitivity to sunlight. See "What should I avoid while using CABTREO".
• Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling.

What is CABTREO?

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina.

These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information, Patient Information and Instructions for Use.