Benzaclin

You should not use this medicine if you are allergic to benzoyl peroxide or clindamycin (Cleocin, Clina-Derm, Clindets).

Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medicine if you have:

• inflammation of your intestines (also called enteritis);

• ulcerative colitis; or

• if you have ever had severe diarrhea caused by antibiotic medicine.

It is not known whether benzoyl peroxide and clindamycin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether benzoyl peroxide and clindamycin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe redness, burning, stinging, or peeling of treated skin areas; or

• diarrhea that is watery or bloody.

Common side effects may include:

• mild burning or stinging;

• itching or tingly feeling;

• dryness or peeling of treated skin; or

• redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this medicine is used.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Throw away any part not used after 3 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

In two adequate and well-controlled clinical studies of 758 patients, 214 used BenzaClin, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; Weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at Week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Nonmedicated make-up could be applied at one hour after the BenzaClin application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:

The BenzaClin group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

BenzaClin Gel contains a combination of benzoyl peroxide and clindamycin. Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that allows excess oil and dirt to be washed away. Clindamycin is an antibiotic that prevents bacteria from growing on the skin.

BenzaClin is used to treat acne.

BenzaClin may also be used for purposes not listed in this medication guide.

Use BenzaClin Gel exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use BenzaClin for longer than your doctor has prescribed.

Avoid getting BenzaClin in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply this medicine to sunburned, windburned, dry, chapped, irritated, or broken skin.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Although BenzaClin is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use BenzaClin if you have inflammation of your intestines (also called enteritis), ulcerative colitis, or if you have ever had severe diarrhea caused by antibiotic medicine.

Avoid exposure to sunlight or tanning beds. BenzaClin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Applies to benzoyl peroxide / clindamycin topical: external gel, external kit

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this drug is used.