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ZoDERM

Generic Name: benzoyl peroxide
Dosage Form: emulsion

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ZoDERM®
(5.75% Benzoyl Peroxide)
Hydrating
Wash™
Benzoyl Peroxide in a Urea Vehicle

Rx Only

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 (Cl4H10O4) is represented by the following chemical structure:

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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 (10%), 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.

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 AND USAGE:

ZoDERM® 5.75% Benzoyl Peroxide HYDRATING WASH™ is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS:

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.

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 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: 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.

ADVERSE REACTIONS:

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

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 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.

Patent Pending

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

IL373

lss.10/07

PharmaDerm®
A division of Nycomed US Inc.
©2008 PharmaDerm, Melville, NY 11747.

All rights reserved.
98NZC010308

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 473 ML LABEL

NDC 10337-758-51

Rx only

ZoDERM®

(5.75% Benzoyl Peroxide)

HYDRATING

WASH

Benzoyl Peroxide in a Urea Vehicle

473 mL

DOAK DERMATOLOGICS

ZoDERM 
benzoyl peroxide hydrating wash emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10337-758
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzoyl peroxide (benzoyl Peroxide) benzoyl peroxide 57.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
urea  
sodium lauryl sulfoacetate  
glycerin  
propylene glycol  
magnesium aluminum silicate  
cetyl alcohol  
glyceryl monostearate  
xanthan gum  
citric acid monohydrate  
sodium citrate  
edetate disodium  
Packaging
# Item Code Package Description
1 NDC:10337-758-51 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 10/09/2009
Labeler - PharmaDerm., A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Revised: 09/2009
 
PharmaDerm., A division of Nycomed US Inc.



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