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Name:Benzoyl Peroxide Wash
Manufacturer:E. Fougera & Co., A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


BENZOYL PEROXIDE5.75% WASH

BENZOYL PEROXIDE WASH - benzoyl peroxide emulsion 
E. Fougera & Co., A division of Nycomed US Inc.

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.

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BENZOYL PEROXIDE
5.75% WASH

Benzoyl Peroxide in
a Urea Vehicle
Rx only

DESCRIPTION:

Benzoyl Peroxide 5.75% 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:

Chemical Structure

Each mL of Benzoyl Peroxide 5.75% 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:

Benzoyl Peroxide 5.75% Wash is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS:

This preparation is contra-indicated 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:

Benzoyl Peroxide 5.75% 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:

Benzoyl Peroxide 5.75% Wash is supplied in 473 mL bottles, NDC 0168-0758-47.

Store at 15°-25° C (59°-77° F).

Protect from freezing.

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

Patent Pending

Manufactured for:
E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Manufactured by: Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA

IL373A
R8/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 473 mL CONTAINER

NDC 0168-0758-47

Fougera®

BENZOYL PEROXIDE

5.75% WASH

Benzoyl Peroxide in a Urea Vehicle

Rx only

473 mL

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 473 mL CONTAINER

PACKAGE CARTON – PRINCIPAL DISPLAY PANEL – 473 ML CARTON

NDC 0168-0758-47

Fougera®

BENZOYL

PEROXIDE

5.75% WASH

Benzoyl Peroxide in a Urea Vehicle

Rx only

473 mL

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

PACKAGE CARTON – PRINCIPAL DISPLAY PANEL – 473 ML CARTON

BENZOYL PEROXIDE WASH 
benzoyl peroxide wash emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0758
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0758-47 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/01/2008

Labeler - E. Fougera & Co., A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)

Revised: 09/2009 E. Fougera & Co., A division of Nycomed US Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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