PERRIGO BENZOYL PEROXIDE AQUEOUS BASE- benzoyl peroxide gel 
Perrigo New York 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 GEL, 5%

Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel

Rx Only

For Topical Use Only

DESCRIPTION

Benzoyl Peroxide Gel, 2.5%, 5%, and 10% Aqueous Base Acne Gels are topical preparations containing benzoyl peroxide as the active ingredient.

Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel contains: 2.5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel contains: 5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel contains: 10% benzoyl peroxide, in an aqueous gel base formulated with carbomer 940, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

The structural formula of benzoyl peroxide is:

chemical structure

CLINICAL PHARMACOLOGY

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

INDICATIONS AND USAGE

Benzoyl Peroxide Gel 2.5%, 5%, and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Gel 2.5%, 5%, and 10% may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

CONTRAINDICATIONS

Benzoyl Peroxide Gel 2.5%, 5%, and 10% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

PRECAUTIONS

General

For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be given to a pregnant woman only if clearly needed.

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 below the age of 12 have not been established.

ADVERSE REACTIONS

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

DOSAGE AND ADMINISTRATION

It is recommended that therapy be initiated with Benzoyl Peroxide Gel, 2.5%, applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Gel, 5% or Benzoyl Peroxide Gel, 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Gel, 2.5%.

Gentle cleansing of the affected areas prior to application of Benzoyl Peroxide Gel, 2.5%, 5%, or 10% may be beneficial.

Clinically visible improvements will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

HOW SUPPLIED

Benzoyl Peroxide Gel 2.5%, 5%, and 10% are available as follows:

Benzoyl Peroxide Gel, 2.5%Aqueous Base Acne Gel

60 g tube (NDC 45802-905-96)

Benzoyl Peroxide Gel, 5%Aqueous Base Acne Gel

60 g tube (NDC 45802-910-96)

90 g tube (NDC 45802-910-01)

Benzoyl Peroxide Gel, 10%Aqueous Base Acne Gel

60 g tube (NDC 45802-915-96)

90 g tube (NDC 45802-915-01)

 STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev. 12/10

305253

: 0H400 RC J2

Principal Display Panel - Carton

Rx Only

Benzoyl Peroxide Gel, 5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% Carton

Benzoyl Peroxide Gel, 5% Carton

Principal Display Panel - Tube

 

Rx Only

Benzoyl Peroxide Gel, 5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% Tube

Benzoyl Peroxide Gel, 5% Tube

 

PERRIGO BENZOYL PEROXIDE  AQUEOUS BASE
benzoyl peroxide gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:45802-910
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
DIMETHICONE 
DISODIUM LAURYL SULFOSUCCINATE 
EDETATE DISODIUM 
GLYCERIN 
HYDRATED SILICA 
METHYLPARABEN 
POLOXAMER 182 
WATER 
SODIUM HYDROXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-910-961 in 1 CARTON
160 g in 1 TUBE
2NDC:45802-910-011 in 1 CARTON
290 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/07/2008
Labeler - Perrigo New York Inc (078846912)

Revised: 3/2011
Document Id: 19004b02-2e4b-4d66-aa84-7a19ad8c3c69
Set id: 01e8bf1e-db02-4dd0-a448-645f0f367401
Version: 5
Effective Time: 20110331
 
Perrigo New York Inc