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Benzoyl Peroxide Cleanser

Generic Name: benzoyl peroxide
Dosage Form: solution

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.

Benzoyl Peroxide Cleanser 3%, 6% and 9%

Rx Only

Benzoyl Peroxide Cleanser Description

Benzoyl Peroxide Cleanser 3%, 6%, and 9% are topical, gel-based, benzoyl peroxide containing preparations for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.

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Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

Benzoyl Peroxide Cleanser 3%, 6% and 9% contain hydrous benzoyl peroxide 3%, 6% and 9% as the active ingredient in a vehicle consisting of: alpha olefin sulfonate, cetostearyl alcohol, glycerin, glyceryl monostearate SE, methylparaben, phosphoric acid, propylene glycol, sodium PCA, white petrolatum and purified water.

Benzoyl Peroxide Cleanser - 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 for Benzoyl Peroxide Cleanser

Benzoyl Peroxide Cleanser 3%, 6%, and 9% is indicated for the topical treatment of acne vulgaris.

Contraindications

These preparations are contraindicated in patients with a history of hypersensitivity to any of their 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 are 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 effect 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 these preparations 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.

Benzoyl Peroxide Cleanser Dosage and Administration

Benzoyl Peroxide Cleansers: Wash affected areas once or twice daily, or as directed by your dermatologist. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often.

How is Benzoyl Peroxide Cleanser Supplied

Benzoyl Peroxide Cleanser 3%
6 oz. (170 g) tube - NDC 68462-411-38
12 oz. (340 g) bottle - NDC 68462-411-34

Benzoyl Peroxide Cleanser 6%
6 oz. (170 g) tube - NDC 68462-412-38
12 oz. (340 g) bottle - NDC 68462-412-34

Benzoyl Peroxide Cleanser 9%
6 oz. (170 g) tube - NDC 68462-413-38
12 oz. (340 g) bottle - NDC 68462-413-34

Store at 15° to 25°C (59° to 77°F). [see USP Controlled Room Temperature].

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

February 2009

3% Principal Display Panel

6% Principal Display Panel

9% Principal Display Panel

BENZOYL PEROXIDE 
benzoyl peroxide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-411
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
GLYCERIN  
GLYCERYL MONOSTEARATE  
METHYLPARABEN  
PHOSPHORIC ACID  
PROPYLENE GLYCOL  
SODIUM PYRROLIDONE CARBOXYLATE  
PETROLATUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:68462-411-38 177.4 mL in 1 TUBE
2 NDC:68462-411-34 354.9 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/20/2009
BENZOYL PEROXIDE 
benzoyl peroxide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-412
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 6 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
GLYCERIN  
GLYCERYL MONOSTEARATE  
METHYLPARABEN  
PHOSPHORIC ACID  
PROPYLENE GLYCOL  
SODIUM PYRROLIDONE CARBOXYLATE  
PETROLATUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:68462-412-38 177.4 mL in 1 TUBE
2 NDC:68462-412-34 354.9 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/20/2009
BENZOYL PEROXIDE 
benzoyl peroxide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-413
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 9 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
GLYCERIN  
GLYCERYL MONOSTEARATE  
METHYLPARABEN  
PHOSPHORIC ACID  
PROPYLENE GLYCOL  
SODIUM PYRROLIDONE CARBOXYLATE  
PETROLATUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:68462-413-38 177.4 mL in 1 TUBE
2 NDC:68462-413-34 354.9 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/20/2009
Labeler - Glenmark Generics Inc., USA (835917282)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Limited 677318665 ANALYSIS, MANUFACTURE
Revised: 12/2009
 
Glenmark Generics Inc., USA
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