Perrigo Benzoyl Peroxide Gel: Package Insert / Prescribing Info

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

Adverse Reactions/Side Effects

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 and Handling

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

Principal Display Panel - Tube

Rx Only

Benzoyl Peroxide Gel, 2.5%

For Topical Use Only

Aqueous Base Acne Gel