Perrigo Benzoyl Peroxide Gel

Dosage Form: aqueous base gel
BENZOYL PEROXIDE GEL, 2.5%

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

Perrigo Benzoyl Peroxide Gel 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:

Perrigo Benzoyl Peroxide Gel - 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 for Perrigo Benzoyl Peroxide Gel

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.

Perrigo Benzoyl Peroxide Gel 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 is Perrigo Benzoyl Peroxide Gel 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, 2.5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 2.5% Carton

Principal Display Panel - Tube

Rx Only

Benzoyl Peroxide Gel, 2.5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 2.5% Tube

BENZOYL PEROXIDE  AQUEOUS BASE benzoyl peroxide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-905 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 g  in 100 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-905-96 1 TUBE In 1 CARTON contains a TUBE 1 60 g In 1 TUBE This package is contained within the CARTON (45802-905-96)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/24/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 10/2011Perrigo New York Inc

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