DESCRIPTION:

5.75% Benzoyl Peroxide Wash is intended for topical administration and contains 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. Benzoyl Peroxide is C14H10O4.

Each mL of 5.75% Benzoyl Peroxide Wash contains 57.5 mg of benzoyl peroxide in an emulsion-based formulation consisting of: Purified Water, Urea (10%), Sodium Lauryl Sulfoacetate, Gycerine, Propylene Glycol, Magnesium Aluminum Silicate, Disodium Oleamido MEA Sulfosuccinate, Sodium Octoxynol-2 Ethane Sulfonate, Cetyl Alcohol, Laureth 12, GMS 165, Xanthan Gum, Citric Acid, Sodium Citrate, Carbomer 940 and Disodium EDTA.

CLINICAL PHARMACOLOGY:

How Benzoyl Peroxide works is not completely 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 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. It is known that Benzoyl Peroxide is absorbed by the skin and is metabolized to benzoic acid, then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans.

INDICATIONS AND USAGE:

5.75% Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS:

This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

WARNINGS:

When using this product, avoid unnecessary sun exposure and use a sunscreen.

PRECAUTIONS:

General: For external use only. If severe irritation develops, discontinue use and utilize the appropriate therapy. After the reaction clears, with less frequent application, treatment may often be resumed. Do not use 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 is 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 pregnant women or can affect reproduction capacity. Benzoyl Peroxide should be used by pregnant women 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 administered to nursing women.

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE:

If excessive scaling, erythema or edema occurs discontinue use. Cool compresses may be used to help soothe any adverse effects. After symptoms subside, if the reaction is judged to be caused by excessive use and not due to an allergic reaction, a reduced dosage schedule may be tried with caution.

DOSAGE AND ADMINISTRATION:

5.75% Benzoyl Peroxide Wash: Cleanse affected areas once or twice a day, or as directed by your dermatologist. Wet skin and apply liberally to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, it may be controlled by rinsing off 5.75% Benzoyl Peroxide Wash sooner or using less often.

HOW SUPPLIED:

5.75% Benzoyl Peroxide Wash is supplied in 16 fl oz bottles, NDC# 68032-319-16.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 10/08 319-11

PACKAGING:

BENZOYL PEROXIDE
benzoyl peroxide liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68032-319
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	57.5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
UREA
SODIUM LAURYL SULFOACETATE
GLYCERIN
PROPYLENE GLYCOL
MAGNESIUM ALUMINUM SILICATE
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE
ENTSUFON SODIUM
CETYL ALCOHOL
LAURETH-12
XANTHAN GUM
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
CARBOMER HOMOPOLYMER TYPE C
EDETATE DISODIUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68032-319-16	473 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2008	05/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC