Perrigo Benzoyl Peroxide
FDA Label NDC 21695-686

Benzoyl Peroxide Gel 5% Hydroalcoholic Base Acne Gel

Benzoyl Peroxide Gel 10% Hydroalcoholic Base Acne Gel

Rx Only

MANUFACTURED BY

STIEFEL LABORATORIES, INC.

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 10/08

302010

: 9X300 RC J2

Repackaged by:

REBEL DISTRIBUTORS CORP

Thousand Oaks, CA 91320

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:

Chemical Structure (De96e1f5 402c 492f B0d1 04fc1bc4fd51 01)

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.

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.

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.

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

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.

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.

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.

Safety and effectiveness in children below the age of 12 have not been established.

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.

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.

Benzoyl Peroxide Gel 5% (Hydroalcoholic Base Acne Gel) are supplied in 60 gram tubes.

Benzoyl Peroxide Gel 5% NDC 21695-686-60

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