Clinac BPO 7

Clinac® BPO 7 (benzoyl peroxide) is a topical preparation containing 7% benzoyl peroxide as the active ingredient in a gel vehicle containing purified water, propylene glycol, Acrysorb® (brand of acrylates copolymer), PEG-400, carbomer 940, disodium EDTA, and sodium hydroxide.

The chemical structure for the active ingredient is:

benzoyl peroxide

C14H10O4 (anhydrous) 242.23

Information for Patients

• Avoid contact with eyes, eyelids, lips and mucous membranes.
• May discolor hair and fabrics.
• Avoid unnecessary sun exposure and use a sunscreen.
• Use of oil-free make-up recommended.
• If severe irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide act as a tumor promoter.  The clinical significance of these finding to humans is not known.  Benzoyl peroxide has not been found to be mutagenic (Ames test) and there are no published data indicating that it impairs fertility.

Pregnancy: Category C

Animal reproductive studies have not been conducted with benzoyl peroxide.  It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Benzoyl peroxide should be used by a pregnant woman only if clearly needed.  There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use

Wash and dry hands, face and affected areas with a gentle cleanser before application.  Apply a thin layer of Clinac® BPO 7 to the affected area once or twice daily, or as directed by your physician.  Replace cap tightly after use.

Clinac® BPO 7  Gel    45 gram tube    NDC 0496-0857-45

Store at 25°C (77°F); excusions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature.].

Rx Only.

Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A
Toll free (888) 548-0900
www.ferndalelabs.com

Protected under U.S. Patent.
Clinac® and Acrysorb® are registered trademarks of Dow Pharmaceutical Sciences Corp.

Applies to benzoyl peroxide topical: topical bar, topical cream, topical foam, topical gel/jelly, topical liquid, topical lotion, topical pad, topical soap, topical solution

Along with its needed effects, benzoyl peroxide topical (the active ingredient contained in Clinac BPO) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzoyl peroxide topical:

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
• skin rash

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

Get emergency help immediately if any of the following symptoms of overdose occur while taking benzoyl peroxide topical:

• Burning, itching, scaling, redness, or swelling of skin (severe)

Some side effects of benzoyl peroxide topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dryness or peeling of the skin (may occur after a few days)
• feeling of warmth, mild stinging, and redness of the skin