BENZOYL PEROXIDE WASH, 5% | Perrigo Benzoyl Peroxide

20:08 EDT 7th July 2015 | BioPortfolio
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Benzoyl Peroxide Wash 2.5%, 5% and 10%

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 homopolymer type C, 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:

IMAGE 2562e53d-fb83-404a-a011-9e6d9b982be5-01.jpg

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 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.

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.

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 given to 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.

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.

Benzoyl Peroxide Wash 2.5%, 5% and 10% are available as follows:

Benzoyl Peroxide Wash 2.5%

8 oz plastic bottle (NDC 45802-907-34)

Benzoyl Peroxide Wash 5%

4 oz plastic bottle (NDC 45802-913-26)

5 oz plastic bottle (NDC 45802-913-01)

8 oz plastic bottle (NDC 45802-913-34)

Benzoyl Peroxide Wash 10%

5 oz plastic bottle (NDC 45802-918-01)

8 oz plastic bottle (NDC 45802-918-34)

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

305263

: 0V500 RC J3

Rx Only

Benzoyl Peroxide Wash 5%

For Topical Use Only

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Manufacturer

Perrigo New York Inc

Active Ingredients

Source

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The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel ...

Study to Compare the Tolerance of Clindamycin 1% and Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2% and BPO 2.5% Topical Acne Medications

This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products,...

A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

5 Day study to assess how quickly a topical acne product begins to work.

A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

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Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

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PubMed Articles [552 Associated PubMed Articles listed on BioPortfolio]

Optimization and Validation of High-Performance Chromatographic Condition for Simultaneous Determination of Adapalene and Benzoyl Peroxide by Response Surface Methodology.

The aim of this study was to develop a simple and reliable high-performance chromatographic (HPLC) method for simultaneous analysis of adapalene and benzoyl peroxide in pharmaceutical formulation by r...

Topical therapy for acne in women: is there a role for clindamycin phosphate-benzoyl peroxide gel?

Acne vulgaris (AV) in adult women is commonly encountered in clinical dermatology practice. This patient subset often experiences psychosocial effects that differ in some ways from those experienced b...

Concise and Efficient Synthesis of 3'-O-Tetraphosphates of 2'-Deoxyadenosine and 2'-Deoxycytidine.

We describe concise and efficient synthesis of biologically very important 3'-O-tetraphosphates namely 2'-deoxyadenosine-3'-O-tetraphosphate (2'-d-3'-A4P) and 2'-deoxycytidine-3'-O-tetra-phosphate (2'...

The efficacy and tolerability of a fixed combination clindamycin (1.2%) and benzoyl peroxide (3.75%) aqueous gel in patients with facial acne vulgaris: gender as a clinically relevant outcome variable.

To investigate whether treatment differences exist in male and female patients with moderate to severe acne treated with clindamycin phosphate 1.2%/BP 3.75% gel or vehicle as monotherapy.

Nitric oxide inhibitory activity and antioxidant evaluations of 2-benzoyl-6-benzylidenecyclohexanone analogs, a novel series of curcuminoid and diarylpentanoid derivatives.

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