CABTREO is a prescription medicine used on the skin (topical) to treat acne vulgaris in adults and children 12 years of age and older. It is not known if CABTREO is safe and effective in children under 12 years of age.

Do not use CABTREO if you have:

• had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO.
• Crohn’s disease or ulcerative colitis.
• had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use.

Talk with your healthcare provider if you are not sure if you have any of the conditions listed above.

Before using CABTREO, tell your healthcare provider about all of your medical conditions, including if you:

• plan to have surgery. CABTREO may affect how certain medicines work that may be given during surgery.
• are pregnant or plan to become pregnant. It is not known if CABTREO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if CABTREO passes into your breast milk. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with CABTREO.

If you use CABTREO while breastfeeding:

• use CABTREO on the smallest area of skin and for the shortest time needed.
• do not apply CABTREO directly to the nipple and areola to avoid getting CABTREO into your baby’s mouth.
• avoid direct skin contact with your baby if CABTREO is applied to your chest.

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

• Especially tell your healthcare provider if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. CABTREO should not be used with products that contain erythromycin.

Especially tell your healthcare provider about any skin products you use. Other skin and topical acne products may increase the irritation of your skin when used with CABTREO.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Use CABTREO exactly as your healthcare provider tells you to use it. See the detailed “Instructions for Use” for directions about how to apply CABTREO.

• Apply a thin layer of CABTREO to cover the treatment area 1 time each day.
• Avoid applying CABTREO to the eyes, lips, creases around your nose, your mouth, and areas of your skin with cuts, abrasions, or sunburned skin.
• Before you apply CABTREO, wash your face gently with a mild or soapless cleanser, rinse with warm water, and pat your skin dry.
• Wash your hands right away after applying CABTREO.

Avoid or limit your time in sunlight, including use of tanning beds or sunlamps during treatment with CABTREO. CABTREO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear wide-brimmed hat and clothes that cover the treated area 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, sunburn, or eczema.
• Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.
• Avoid the use of “waxing” as a hair removal method on skin treated with CABTREO.
• Avoid getting CABTREO in your hair or on colored fabric. CABTREO may bleach hair or colored fabric.

CABTREO may cause serious side effects, including:

• Allergic reactions. Stop using CABTREO, and get help right away if you have any of the following symptoms during treatment with CABTREO:
  • hives, rash, or severe itching
  • swelling of your face, eyes, lips, tongue, or throat
  • trouble breathing or throat tightness
  • feeling faint, dizzy, or lightheaded
• Inflammation of the colon (colitis). Stop using CABTREO and call your healthcare provider right away 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. Skin irritation is common with CABTREO and is most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of CABTREO. Skin reactions at the treatment area include redness, scaling, dryness, stinging, burning, itching, and swelling.

Tell your healthcare provider if you get any skin reactions.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of CABTREO.

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

• Store CABTREO at room temperature at or below 77°F (25°C).
• Do not freeze CABTREO.
• Keep CABTREO away from heat.
• Store CABTREO pump upright.
• Throw away (discard) CABTREO that has passed the expiration date.

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

General information about the safe and effective use of CABTREO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CABTREO for a condition for which it was not prescribed. Do not give CABTREO 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 CABTREO that is written for health professionals.

Active ingredient: clindamycin phosphate, adapalene, and benzoyl peroxide.

Inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.

Your role as a parent or guardian is crucial in your child’s acne treatment with CABTREO. You’re there to ensure they use the medication as directed, remind them about consistency, and help them communicate with their healthcare provider if necessary.