 |
Clinac™ BPO is a topical preparation containing benzoyl peroxide 7% as the active ingredient in a gel vehicle containing purified water, propylene glycol, acrylate copolymer (DVB/isobornyl methacrylate/lauryl methacrylate copolymer), PEG-400, carbomer 940, disodium EDTA and sodium hydroxide.
The chemical structural formula for active ingredient:
|
|
C 14 H 10 O 4 (anhydrous) 242.23
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.
Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.
Clinac BPO is indicated for topical treatment of mild to moderate acne vulgaris. Your physician may prescribe Clinac BPO as an adjunct in acne treatment regimens including retinoic acid products, antibiotics, and sulfur/salicylic acid containing preparations.
Clinac BPO should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in this product.
For external use only. Avoid contact with the eyes and mucous membranes. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately. Since benzoyl peroxide will cause bleaching, avoid contact with hair, fabrics or carpeting.
Benzoyl peroxide is not considered to be a carcinogen and there are no published data indicating it impairs fertility. 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 unknown.
Animal reproduction 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.
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.
Wash and dry hands, face and affected areas with a gentle cleanser before application. Apply a thin layer of Clinac BPO to the affected areas once or twice daily, or as directed by your physician. Wipe off excess gel with a clean tissue. Clinically visible improvement usually occurs by the third week of therapy. Consistent use of the drug is normally required to sustain satisfactory clinical response. It is recommended that only completely oil-free make-up be used in conjunction with this product. The oil imbibing polymers within the gel vehicle cause smearing/smudging of oil containing cosmetics.
CLINAC™ BPO (benzoyl peroxide 7%) Gel USP
For the treatment of acne and reduction of excess facial oil.
Store at controlled room temperature between 59°-86°F (15°-30°C).
Rx Only.
FERNDALE
LABORATORIES INC
ETHICAL PHARMACEUTICALS SINCE 1897
Ferndale, Michigan 48220
Toll Free (888) 548-0900 • www.ferndalelabs.com
Clinac™ BPO is a trademark of Ferndale Laboratories, Inc.
©1998 Ferndale Laboratories, Inc.
Protected under U.S. Patent
Rev.: 08/00
MG #14238