Perrigo Benzoyl Peroxide

Perrigo New York Inc

BENZOYL PEROXIDE ALCOHOL BASE GEL, 5%

FULL PRESCRIBING INFORMATION: CONTENTS*

• PERRIGO BENZOYL PEROXIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PERRIGO BENZOYL PEROXIDE INDICATIONS AND USAGE
• PERRIGO BENZOYL PEROXIDE CONTRAINDICATIONS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• PERRIGO BENZOYL PEROXIDE ADVERSE REACTIONS
• PERRIGO BENZOYL PEROXIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Principal Display Panel - 60 g Carton
• Principal Display Panel - 60 g Tube

FULL PRESCRIBING INFORMATION

Benzoyl Peroxide Gel 5% Hydroalcoholic Base Acne Gel

Benzoyl Peroxide Gel 10% Hydroalcoholic Base Acne Gel

Rx Only

PERRIGO BENZOYL PEROXIDE DESCRIPTION

Benzoyl Peroxide Gel 5% and 10% (Hydroalcoholic Base Acne Gels) are topical preparations containing benzoyl peroxide as the active ingredient.

Benzoyl Peroxide Gel 5% contains: 5% benzoyl peroxide in a hydroalcoholic gel base formulated with alcohol (12%, denatured with tert-butyl alcohol and denatonium benzoate), citric acid, disodium lauryl sulfosuccinate, hypromellose, laureth-12, magnesium aluminum silicate, and purified water. Benzoyl Peroxide Gel 10% contains: 10% benzoyl peroxide in a hydroalcoholic gel base formulated with alcohol (20%, denatured with tert-butyl alcohol and denatonium benzoate), citric acid, hypromellose, laureth-12, magnesium aluminum silicate, and purified water.

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.

PERRIGO BENZOYL PEROXIDE INDICATIONS AND USAGE

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

PERRIGO BENZOYL PEROXIDE CONTRAINDICATIONS

Benzoyl Peroxide Gel 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

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.

PERRIGO BENZOYL PEROXIDE 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 DOSAGE AND ADMINISTRATION

It is recommended that therapy be initiated with Benzoyl Peroxide Gel 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 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Gel 5%.

Gentle cleansing of the affected areas prior to application of Benzoyl Peroxide Gel 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 5% and 10% (Hydroalcoholic Base Acne Gels) are supplied in 60 gram tubes.

Benzoyl Peroxide Gel 5% Benzoyl Peroxide Gel 10%

Hydroalcoholic Base Acne Gel Hydroalcoholic Base Acne Gel 60 g tube NDC 45802-995-96 60 g tube NDC 45802-921-96

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

302010

: 9X300 RC J2

Principal Display Panel - 60 g Carton

Benzoyl Peroxide Gel 5%

Hydroalcoholic Base Acne Gel

For Topical Use

Rx Only

Principal Display Panel - 60 g Tube

Benzoyl Peroxide Gel 5%

Hydroalcoholic Base Acne Gel

For Topical Use

Rx Only