Benzac AC® 2 1 / 2 , 5 and 10 (benzoyl peroxide gel), Benzac AC® Wash 2 1 / 2 , 5 and 10 (benzoyl peroxide), are topical, water-base, benzoyl peroxide containing preparations for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent which possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following chemical structure:
Benzac AC® 2 1 / 2 , Benzac AC® 5, and Benzac AC® 10 contain, respectively, benzoyl peroxide 2 1 / 2 %, 5% and 10% as the active ingredient in a gel base containing docusate sodium, edetate disodium, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerin, silicon dioxide, sodium hydroxide and purified water. May contain citric acid to adjust pH.
Benzac AC® Wash 2 1 / 2 , Benzac AC® Wash 5 and Benzac AC® Wash 10 contain, respectively, benzoyl peroxide 2 1 / 2 %, 5% and 10% as the active ingredient in a vehicle consisting of purified water, sodium C14-16 olefin sulfonate, acrylates copolymer, glycerin, sodium hydroxide, and carbomer 940. May contain citric acid to adjust pH.
The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids and mild desquamation (drying and peeling activity) with a simultaneous reduction in comedones and acne lesions.
Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
Benzac AC® 2 1 / 2 , 5 and 10 and Benzac AC® Wash 2 1 / 2 , 5 and 10 are indicated for the topical treatment of acne vulgaris.
These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After the reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promotor. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with benzoyl peroxide. It is 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: Safety and effectiveness in children have not been established.
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
If excessive scaling, erythema or edema occur, the use of this preparation should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
Benzac AC® 2 1 / 2 , 5 or 10 should be applied once or twice daily to cover affected areas after washing with a mild cleanser and water.
Benzac AC® Wash 2 1 / 2 , 5 or 10. Wash once or twice daily avoiding contact with the eyes and mucous membranes. Wet the area of application. Apply Benzac AC® Wash 2 1 / 2 , 5 or 10 to the hands and wash the affected areas. Rinse with water and pat dry.
Benzac AC® 2 1 / 2 Water Base Gel
60 g tubes-- NDC 0299-3620-60
90 g tubes-- NDC 0299-3620-90
Benzac AC® 5 Water Base Gel
60 g tubes-- NDC 0299-3625-60
90 g tubes-- NDC 0299-3625-90
Benzac AC® 10 Water Base Gel
60 g tubes-- NDC 0299-3630-60
90 g tubes-- NDC 0299-3630-90
8 oz plastic bottles-- NDC 0299-3635-08
8 oz plastic bottles-- NDC 0299-3640-08
8 oz plastic bottles-- NDC 0299-3645-08
Store Benzac AC® and Benzac AC® Wash at controlled room temperature (59°-86°F).
Federal law prohibits dispensing without prescription.
Revised: March 1994