PERRIGO BENZOYL PEROXIDE WASH - benzoyl peroxide lotion 
Perrigo New York Inc

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BENZOYL PEROXIDE WASH, 5%

Benzoyl Peroxide

Wash 2.5%, 5% and 10%

Rx Only

DESCRIPTION

Benzoyl Peroxide Wash 2.5%, 5% and 10% are topical preparations containing benzoyl peroxide as the active ingredient.

Benzoyl Peroxide Wash 2.5%, 5% and 10% each contain: 2.5%, 5% and 10% benzoyl peroxide, respectively, in a lathering base formulated with acrylates copolymer, carbomer 940, edetate disodium, glycerin, imidurea, purified water, sodium hydroxide, sodium C14-16 olefin sulfonate. May contain citric acid to adjust pH.

The structural formula of benzoyl peroxide is:

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 Wash 2.5%, 5% and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Wash 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 Wash 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 used by 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

Shake well before using. It is recommended that therapy be initiated with Benzoyl Peroxide Wash 2.5%, washing the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply Benzoyl Peroxide Wash, work to a full lather, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Wash 5% or 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Wash 2.5%. Clinically visible improvement 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 Wash 2.5%, 5% and 10% are supplied as follows:

Benzoyl Peroxide Wash 2.5%

8.0 oz plastic bottle

NDC 45802-907-34

Benzoyl Peroxide Wash 5%

4.0 oz plastic bottle 5.0 oz plastic bottle

NDC 45802-913-26 NDC 45802-913-01

8.0 oz plastic bottle

NDC 45802-913-34

Benzoyl Peroxide Wash 10%

5.0 oz plastic bottle 8.0 oz plastic bottle

NDC 45802-918-01 NDC 45802-918-34

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

MANUFACTURED BY

STIEFEL LABORATORIES, INC.

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 10/08

302009

0V500 RC J2

Principal Display Panel - 4 oz Label

Benzoyl Peroxide Wash 5%

For Topical Use

Rx Only

Principal Display Panel - 5 oz Label

Benzoyl Peroxide Wash 5%

For Topical Use

Rx Only

Principal Display Panel - 8 oz Label (Front and Back)

Benzoyl Peroxide Wash 5%

For Topical Use

Rx Only

PERRIGO BENZOYL PEROXIDE  WASH benzoyl peroxide   lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-913 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 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 45802-913-26 113 g In 1 BOTTLE None 2 45802-913-01 142 g In 1 BOTTLE None 3 45802-913-34 227 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/15/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 11/2009Perrigo New York Inc