Zoderm

h3>DESCRIPTION

ZoDerm® 5.75% Benzoyl Peroxide Hydrating 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 mL of ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ contains 57.5 mg of benzoyl peroxide in an emulsion-based formulation consisting of: purified water,urea(100/o),sodium lauryl sulfoacetate, glycerin, propylene glycol, magnesium aluminum silicate, disodium oleamido MEA-sulfosuccinate, sodium octoxynol-2 ethane sulfonate, cetyl alcohol, laureth-12, glyceryl stearate/PEG-100 stearate, xanthan gum, citric acid, sodium citrate, carbomer and disodium EDTA.

INDICATIONS

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™

Wash affected areas once or twice a day, or as directed by your dermatologist. 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, it may be controlled by rinsing off hydrating wash sooner or using less often.

HOW SUPPLIED

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ is supplied in 473 mL bottles, NDC 10337-758-51.

Store at controlled room temperature 15°-25° C (59°-77° F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for: DERM/arts., Division Doak Dermatologics A Subsidiary Of Bradley Pharmaceuticals, Inc. 383 Route 46 West Fairfield, NJ 07004-2402, USA. www.doakderm.com. Manufactured by: Groupe Parima, Inc. Montreal, QC H4S 1X6 CANADA.

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

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.

Carcinogenesis, 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 tu mor promoter. The clinical significance of these findings to humans is unknown. Benzoyl Peroxide has not been found to be mutagenic (Ames Test) and thereare 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 theeffect 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.

OVERDOSE

If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued.Tohasten 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.

CONTRAINDICATIONS

This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

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, patientstreated 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.

PATIENT INFORMATION

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.