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


Benzoyl Peroxide Wash 7%

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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Benzoyl Peroxide Wash 7%

INDICATIONS AND USAGE

Benzoyl Peroxide Wash 7% is indicated for use in the topical treatment of mild to moderate acne vulgaris.

DOSAGE AND ADMINISTRATION

Benzoyl Peroxide Wash 7% should be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. 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. Shake well before using. Wet skin areas to be treated; apply Benzoyl Peroxide Wash 7% by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.

DOSAGE FORM AND STRENGTH

Benzoyl peroxide 7% topical preparation

CONTRAINDICATIONS

Benzoyl Peroxide Wash 7% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.

General: For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.

Information for the Patient: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician.

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

The use of tretinoin and hydroquinone topical preparations should be avoided when using this product.

USE IN SPECIFIC POPULATIONS

Pregnancy
Category C - 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 used by a pregnant woman only if clearly needed.

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 a nursing woman.

Pediatric Use
Safety and effectiveness in children below the age of 12 have not been established.

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.

DESCRIPTION

Benzoyl Peroxide Wash 7% is a topical preparation containing benzoyl peroxide as the active ingredient incorporated into a series of microscopic concentric vesicules of oil and water. This system results in the release of the active ingredient into the skin over a sustained period of time. Ingredients include: Citric Acid, cocamidopropyl betaine, cocamine oxide, disodium laureth sulfosuccinate, disodium EDTA, Fragrance Lemon, Glycerin, Hydrogenated Castor Oil, Hypromellose, Magnesium Aluminum Silicate, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Methylparaben, PEG-150 Pentaerythrityl Tetrastearate and Aqua and PEG-6 Caprylic/Capric Glycerides, PEG-40 Hydrogenated Castor Oil, Poloxamer 182, Purified Water and Xanthan Gum.

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.

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.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility
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.

HOW SUPPLIED/STORAGE AND HANDLING

Benzoyl Peroxide Wash 7% is supplied as follows:
SIZE: 6.35 oz. (180 g) bottle
NDC #: 68032-420-18

Storage Conditions:
Store between 15-30° C (59°- 86°F). Protect from freezing.

PATIENT COUNSELING INFORMATION

GENERAL INFORMATION
Patients should be advised of the following:
• Avoid contact with eyes, eyelids, lips, and mucous membranes while using benzoyl peroxide. If accidental contact occurs, rinse with water.
• If excessive irritation develops, discontinue use and consult their physician.
• When using this product, avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with hair, fabrics, or carpeting as benzoyl peroxide will cause bleaching or discoloration.

ADVERSE REACTIONS
Patients should be informed that treatment with topical benzoyl peroxide may lead to adverse reactions that include allergic contact dermatitis and dryness.

EXCESSIVE USE OF TOPICAL BENZOYL PEROXIDE
Patients should be advised to discontinue use and consult their physician if excessive scaling, erythema, or edema occurs. Advise the use of cool compresses to hasten resolution of the adverse effects. 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.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 07/09 420-115

PACKAGING

label

BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-420
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 70 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
COCAMIDOPROPYL BETAINE  
DIHYDROXYETHYL COCAMINE OXIDE  
DISODIUM LAURETH SULFOSUCCINATE  
EDETATE DISODIUM  
GLYCERIN  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM ALUMINUM SILICATE  
CETOSTEARYL ALCOHOL  
LAURETH-3  
POLYSORBATE 60  
METHYLPARABEN  
POLYETHYLENE GLYCOL 6000  
POLYETHYLENE GLYCOL 300  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
POLOXAMER 182  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-420-18 180 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 10/31/2011

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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