DELOS - benzoyl peroxide liquid
Rochester Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DESCRIPTION

Delos™ (3.5% benzoyl peroxide) cleanser is a topical preparation containing benzoyl peroxide, for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic agent. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

Delos™ (3.5% benzoyl peroxide) cleanser contains benzoyl peroxide USP 3.5% as the active ingredient in a formulation consisting of: Cetearyl Alcohol, Ceteareth-20, Citric Acid, Cocamidopropyl Betaine, Cocamine Oxide, Disodium Laureth Sulfosuccinate, Edetate Disodium, Magnesium Aluminum Silicate, Methylparaben, PEG-15 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, PEG-150 Stearate, 2-Phenoxyethanol, Poloxamer 182, Polyethylene, Sodium Polyacrylate, PPG-20 Methyl Glucose Ether, Propylene Glycol, Purified Water, and Xanthan Gum.

CLINICAL PHARMACOLOGY

The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action, in addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

INDICATIONS & USAGE

Delos™ (3.5% benzoyl peroxide) cleanser is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS

These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS

When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children.

PRECAUTIONS

General

For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

Pregnancy: Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

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 used by a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

OVERDOSAGE

If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE & ADMINISTRATION

Wash affected areas Delos™ (3.5% benzoyl peroxide) cleanser once or twice daily, rinse and pat dry; or as directed by your physician.

HOW SUPPLIED

Delos™ (3.5% benzoyl peroxide) cleanser is available in 180 g tube (NDC 49908-123-80).

Store at controlled room temperature: 15° - 30° C (59° - 86° F).

Manufactured for:
Rochester Pharmaceuticals
Rochester, NY 14625
Toll Free: 1-866-458-1772
www.RoshesterPharm.com
www.DelosCleanser.com

September 2010

PACKAGE LABEL

NDC 49908-123-80

For dermatologic use only - Not for ophthalmic use

Rx only

delos™

(3.5% benzoyl peroxide) cleanser

6 oz (180 g)

Usual dosage: Wash affected areas with Delos™ (3.5% benzoyl peroxide) cleanser once or twice daily, rinse and pat dry; or as directed by your physician.

Each gram contains - Active: benzoyl peroxide 3.5%. Inactive: Cetearyl Alcohol, Ceteareth-20, Citric Acid, Cocamidopropyl Betaine, Cocamine Oxide, Disodium Laureth Sulfosuccinate, Edetate Disodium, Magnesium Aluminum Silicate, Methylparaben, PEG-15 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, PEG-150 Stearate, 2-Phenoxyethanol, Poloxamer 182, Polyethylene, Sodium Polyacrylate, PPG-20 Methyl Glucose Ether, Propylene Glycol, Purified Water, and Xanthan Gum.

Avoid application close to the eyes. See package insert for full prescribing information.

Important: Do not use if seal has been punctured or is not visible.

Store at 15°-30°C (59°-86°F)

See crimp for lot no. and expiration date.

Distributed by: Rochester Pharmaceuticals
Rochester, NY 14625 • www.RochesterPharm.com

Rochester™ Pharmaceuticals