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Name:Benzoyl Peroxide
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


5.75% Benzoyl Peroxide Wash

BENZOYL PEROXIDE  - benzoyl peroxide liquid 
River's Edge Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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5.75% Benzoyl Peroxide Wash

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.

Pregnanc
y: 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:

label

BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC: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: 12/2010 River's Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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