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BP Wash

Generic Name: benzoyl peroxide
Dosage Form: liquid

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.

BP 7% Wash

Indications and Usage for BP Wash

BP 7% Wash is indicated for use in the topical treatment of acne vulgaris.

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BP Wash Dosage and Administration

BP 7% Wash should be used once or twice daily on the affected areas, or as directed by a physician. Wet skin areas to be treated. Liberally apply, BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, rinse the cleanser off sooner or use less often.

DOSAGE FORM AND STRENGTH

Benzoyl peroxide 7% topical preparation

Contraindications

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

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. Once irritation clears, treatment may often be resumed with less frequent application.

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. 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 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.

BP Wash Description

BP 7% Wash is a topical preparation containing benzoyl peroxide as the active ingredient for use in the treatment of acne vulgais. Each mL of BP 7% Wash contains 70mg of benzoyl peroxide in an emulsion base consisting of: Aloe Barbedensis Leaf Extract, Carbomer, Cetyl Alcohol, Disodium Laureth Sulfosuccinate, PEG-100 Stearate, Glycerin, Camellia Oleifera Leaf (Green Tea) Extract, Octoxynol-13, Magnesium Aluminum Silicate, Propylene Glycol, Purified Water, PPG-14 Palmeth-60 Hexyl Dicarbamate, Xanthan Gum, Allantoin, Benzyl Alcohol, Glyceryl Stearate, Panthenol, Sodium Citrate, Sodium Hyaluronate, Triethanolamine.

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

CLINCIAL PHARMACOLOGY

The exact mechanism 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 absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine. There is no evidence of systemic toxicity in humans caused by benzoyl peroxide.

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. Benzoyl peroxide has not been found to be mutagenic (Ames Test). There are no published data indicating impairment of fertility.

How Supplied/Storage and Handling

BP 7% Wash is supplied as follows:
SIZE: 16 ounce bottle
NDC #: 68032-427-16

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

PACKAGING

NDC 68032-427-16
Rx Only
BP 7% Wash
7% Benzoyl Peroxide
In a vehicle containing Aloe and Green Tea
TOPICAL ACNE THERAPY
Net Wt. 16 oz.

DIRECTIONS: Shake well before using. Wet areas to be treated and liberally apply BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. Avoid contact with eyes, eyelids, and lips.

ACTIVE INGREDIENT: Benzoyl peroxide 7%
INACTIVE INGREDIENTS: Aloe Barbedensis Leaf Extract, Carbomer, Cetyl Alcohol, Disodium Laureth Sulfosuccinate, PEG-100 Stearate, Glycerin, Camellia Oleifera Leaf (Green Tea) Extract, Octoxynol-13, Magnesium Aluminum Silicate, Propylene Glycol, Purified Water, PPG-14 Palmeth-60 Hexyl Dicarbamate, Xanthan Gum, Allantoin, Benzyl Alcohol, Glyceryl Stearate, Panthenol, Sodium Citrate, Sodium Hyaluronate, Triethanolamine.

WARNINGS:
KEEP OUT OF REACH OF CHILDREN.
For External Use Only.
When using this product, avoid unnecessary sun exposure and use a sunscreen. Benzoyl peroxide may bleach colored or dyed fabric.

See package insert for full prescribing information.

Store at controlled room temperature 15-30C (59-86F).
Protect from freezing.

BP 
bp 7% wash liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-427
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 7   in 473 mL
Packaging
# Item Code Package Description
1 NDC:68032-427-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 08/01/2009
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 11/2009
 
River's Edge Pharmaceuticals, LLC
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