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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:
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The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes . This action combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.
Little is known about the percutaneous penetration, metabolism and excretion of benzoyl peroxide. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
Clinac® BPO 7 is indicated for the topical treatment of mild to moderate acne vulgaris. Clinac® BPO 7 may be used with other acne treatments including retinoic acid products, antibiotics and sulfur/salicylic acid containing preparations.
Clinac® BPO 7 should not be used in patients who have shown hypersensitivity to benzoyl peroxide or any of the other ingredients in this product.
FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, eyelids, lips and mucous membranes. If inadvertent contact occurs, rinse area thoroughly with water. Contact with colored material, including fabric and hair, may result in discoloration. When using Clinac® BPO 7, avoid unnecessary sun exposure and use a sunscreen. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings 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.
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.
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.
Safety and effectiveness in children below the age of 12 have not been established.
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. If excessive scaling, erythema or edema occurs, the use of Clinac® BPO 7 should be discontinued and appropriate therapy instituted. To hasten resolution of adverse effects, cool compresses may be used. After reaction clears, a reduced dosage schedule may often be resumed if the reaction is judged not to be due to allergenicity.
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 controlled room temperature 59°-86°F (15°-30°C).
Rx Only.
FERNDALE
LABORATORIES INC
ETHICAL PHARMACEUTICALS SINCE 1897
Ferndale, MI 48220 U.S.A.
Toll Free: (888) 548-0900 · www.ferndalelabs.com
Clinac® is a registered trademark and Acrysorb™ is a trademark of Dow Pharmaceutical Sciences Corp.
MG #14238
Rev: 02/03