Zoderm (OTHER DERMATOLOGICAL )

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.

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

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.

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

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.

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

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.

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.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.