FDA Label for Pr Benzoyl Peroxide Wash

Description

DESCRIPTION:
PR^TM Benzoyl Peroxide 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 s a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the
following chemical structure:
O = C – O – O – C = O

Each mL of PR^TM Benzoyl Peroxide Wash contains 70 mg of Benzoyl Peroxide 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.

Clinical Pharmacology

CLINICAL PHARMACOLOGY:
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.

Indications & Usage

INDICATIONS AND USAGE:
PR^TM Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris.

Contraindications

CONTRAINDICATIONS:
PR^TM Benzoyl Peroxide Wash is contraindicated in persons with a known hypersensitivity to any of its ingredients.

Warnings And Precautions

WARNINGS:
When using this product, avoid unnecessary sun exposure and use a sunscreen.
PRECAUTIONS:
General: 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.

Information For Patients

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

Carcinogensesis, Mutagenesis, Impairment of Fertility:
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.

Pregnancy

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.

Adverse Reactions

ADVERSE REACTIONS:
Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy.

Overdosage

OVERDOSAGE:
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.

Dosage & Administration

DOSAGE AND ADMINISTRATION:
PR^TM Benzoyl Peroxide 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 of cleanser sooner or using less often.

How Supplied

HOW SUPPLIED:
PR^TM Benzoyl Peroxide Wash is supplied in a 16 oz bottle, NDC 42546-145-16.

Storage And Handling

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.

Principal Display Panel - 473 Ml Bottle Box

NDC 42546-145-16

PR^™
Benzoyl Peroxide
Wash (7% Benzoyl Peroxide)

TOPICAL ACNE THERAPY

7%

Rx only
Net wt. 16 oz

PRUGEN^™
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Box - benzoyl peroxide 01