Important safety information and consumer warnings you should know about clindamycin and benzoyl peroxide.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Clindamycin and Benzoyl Peroxide (Benzaclin)
This leaflet is part III of a three-part “Product Monograph” published for Benzoyl Peroxide / Clindamycin and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Benzoyl Peroxide / Clindamycin. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
Benzoyl Peroxide / Clindamycin has been prescribed by your doctor to treat your acne.
Benzoyl Peroxide / Clindamycin is not indicated for the treatment of severe (cystic) acne.
What it does:
Clindamycin phosphate and benzoyl peroxide have antibacterial properties. Benzoyl peroxide is also a peeling agent.
Improvement has been seen as early as two weeks, although several months of treatment may be required for best results.
When it should not be used:
Do not use Benzoyl Peroxide / Clindamycin if:
- You are allergic to clindamycin, lincomycin, benzoyl peroxide, or any component of this medication (See “What the medicinal ingredients are” and “What the nonmedicinal ingredients are”).
- You have or have had ulcerative colitis, regional enteritis or antibiotic associated colitis.
What the medicinal ingredients are:
Benzoyl Peroxide / Clindamycin is a mixture of two acne medications, clindamycin phosphate and benzoyl peroxide.
What the nonmedicinal ingredients are:
The non-medicinal ingredients are: carbomer, dioctyl sodium sulfosuccinate, purified water and sodium hydroxide.
What dosage forms it comes in:
Topical gel (clindamycin, as phosphate, 1% and benzoyl peroxide 5%).
WARNINGS AND PRECAUTIONS
- Benzoyl Peroxide / Clindamycin is for external use only. Avoid contact with the eyes, nostrils, mouth, and all mucous membranes. If contact occurs, rinse well with water. If redness or soreness develops, contact your doctor.
- Do not use other topical acne preparations or other topical products, including cosmetics, on the affected area unless directed to do so by your physician. Many cosmetic products may also contain other peeling agents, which may interfere with the medication or worsen potential side effects.
- Exposure to sunlight should be minimized. To minimize exposure to sunlight, a hat or other clothing should be worn. Avoid unnecessary exposure to other sources of UV light (i.e., sun lamps, tanning beds).
- Tell your doctor if you are pregnant, breastfeeding or intend to become pregnant or breastfeed.
- Benzoyl Peroxide / Clindamycin is available only on prescription. It has been prescribed by your doctor to treat your current condition. Do not give this medication to other people.
- Avoid contact with hair, fabrics, carpeting, or other materials, as benzoyl peroxide will cause bleaching.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor if you are using any other medications, particularly clindamycin, erythromycin, lincomycin or chloramphenicol, as they may interfere with each other.
PROPER USE OF THIS MEDICATION
- Prior to using Benzoyl Peroxide / Clindamycin, wash affected areas gently with a mild non-medicated soap, then rinse with warm water and then gently pat dry.
- Apply Benzoyl Peroxide / Clindamycin to the whole area affected by acne, not just to the pimples themselves. Avoid contact with the eyes, nostrils, mouth, and all mucous membranes, as this product may be irritating.
- Apply Benzoyl Peroxide / Clindamycin in a thin layer twice a day, morning and evening, or as directed by your doctor. Wash hands after application. Do not apply more frequently than directed by your doctor. Moisturizer may be used to alleviate dry skin.
- Although improvement has been seen as early as two weeks, several months of treatment may be required for best results. This medication should be used for the entire treatment period prescribed by your doctor even if your acne begins to improve as early as two weeks after you begin using Benzoyl Peroxide / Clindamycin.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You may experience dry skin, itching, redness, irritation and peeling skin. If this persists or becomes bothersome, contact your doctor.
Stop use and immediately inform your doctor if:
- You have an allergic reaction (hypersensitivity) with symptoms such as rash, hives, swelling of the lips, face, eyelids or throat, or difficulty in breathing.
- You develop very rare side effects such as abdominal or stomach cramps, severe abdominal pain and bloating, severe watery diarrhea which may be bloody, nausea and vomiting.
HOW TO STORE IT
- Benzoyl Peroxide / Clindamycin may be stored between 15 °C and 25 °C for up to 3 months after mixing for dispensing.
- An expiry date appears on the product label. You must discard any product you have not used by this date and obtain a fresh supply.
- Do not freeze. Keep jar tightly closed.
- Keep your medication in a safe place, out of the reach of children.