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BenzePro™ Creamy Wash benzoyl peroxide 7.0%PruGen, Inc. Pharmaceuticals
BenzePrOTM Creamy Wash is intended for topical administration and contains Benzoyl Peroxide for use in the treatment of acne vulgaris. Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure:
Each gram of BenzePrOTM Creamy Wash contains 70 mg of Benzoyl Peroxide as microsphere particles (via Curoxyl® 42) in an emulsion based formulation consisting of: aloe, carbomer 940, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, disodium EDTA, glyceryl stearate/PEG-100 stearate, glycerin, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum.
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 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.
BenzePrOTM Creamy Wash is indicated for the topical treatment of acne vulgaris.
BenzePrOTM Creamy Wash is contraindicated in persons with a known hypersensitivity to any of its ingredients.
Do not use if you:
When using this product:
Stop use and ask a doctor if:
For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After 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.
General: If accidental contact occurs with eyes, mouth, or mucous membranes, rinse with water.
Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tumor promoter. 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.
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.
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 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 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.
BenzePrOTM Creamy Wash: Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, control by rinsing off cleanser sooner or using less often.
BenzePrO™ Creamy Wash is supplied in a 180 g bottle (NDC 42546-017-18).
Store at controlled room temperature 20°-25° C (68°-77° F); excursions permitted to 15°-30°C (59°-86°F).
Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:PruGen, Inc. Pharmaceuticals18899 North Thompson Peak ParkwayScottsdale, AZ 85255
NDC 42546-017-18Rx only
benzoyl peroxide 7.0%
Net Wt 180 g
Manufactured for: PruGen, Inc. Pharmaceuticals Scottsdale, AZ 85255 www.prugen.com Rev 1.1
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