BPS Gel

benzoyl peroxide and sulfur

Dosage Form: gel
BPS Gel™

6% Benzoyl Peroxide

3% Sulfur

Rx Only

PRODUCT DESCRIPTION

BPS Gel™ is a topical preparation containing benzoyl peroxide 6% and sulfur 3%. The structural formula of benzoyl peroxide is as follows:

INACTIVE INGREDIENTS: Allantoin, Benzyl Alcohol NF, Carbomer 940 NF, Citric Acid (Anhydrous) USP, Colloidal Oatmeal, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium USP, Glycerin USP, Purified Water USP, Sodium Citrate USP.

BPS Gel - Clinical Pharmacology

The exact mode of action of benzoyl peroxide and sulfur in acne vulgaris is unknown but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. Benzoyl peroxide and sulfur are believed to exert a beneficial effect because of their antimicrobial activity and their mild keratolytic action.

INDICATIONS

BPS Gel™ is indicated in the treatment of acne vulgaris. See Directions section below for information on frequency and duration of medication use.

Contraindications

BPS Gel™ is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide, sulfur, or to any of the other ingredients in the product.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep tube tightly closed.

Warnings

External Use Only. Not for ophthalmic Use. Avoid prolonged sun exposure, tanning booths, and sunlamps.

Precautions

BPS Gel™ is for external use only. Do not come in contact with eyes or mucous membranes (e.g., inside of nose) and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may be resumed with less frequent application. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C

Animal reproduction studies have not been conducted with BPS Gel™. It is also not known whether BPS Gel™ can cause fetal harm when administered to a pregnant woman. This product should be used only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether these drugs are excreted in human milk following topical use of BPS Gel™. However, because many drugs are excreted in human milk, caution should be exercised when administering this medication to a nursing woman.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Adverse Reactions

Contact sensitization reactions are associated with the use of topical benzoyl peroxide and sulfur products, and may be expected to occur in 10 to 25 out of 1,000 patients. The most frequent adverse reaction associated with benzoyl peroxide and sulfur use are excessive erythema (redness) and peeling which may be expected to occur in 5 out of every 100 patients. Excessive erythema (redness) and peeling most frequently appear during the initial phase of medication use and may normally be controlled by reducing frequency of use.

Directions

Cleanse affected areas. Apply the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response.

How is BPS Gel Supplied

BPS Gel™ (benzoyl peroxide 6% and sulfur 3%) is supplied in 43 g. tubes. NDC 51991-634-83.

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss: 1/09

PRINCIPAL DISPLAY PANEL - 43 g Carton

Breckenridge

Pharmaceutical, Inc.

NDC 51991-634-83

BPS Gel™

6% Benzoyl Peroxide

3% Sulfur

Rx Only

Net Wt. 43 g

Acne Treatment Gel

BPS  benzoyl peroxide and sulfur  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-634 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 0.06 g  in 1 g Sulfur (Sulfur) Sulfur 0.03 g  in 1 g

Inactive Ingredients Ingredient Name Strength Allantoin   Benzyl Alcohol   Carbomer Homopolymer Type C   Anhydrous Citric Acid   Oatmeal   Disodium Oleamido MEA-Sulfosuccinate   Edetate Disodium   Water   Sodium Citrate   Glycerin

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-634-83 1 TUBE In 1 BOX contains a TUBE 1 43 g In 1 TUBE This package is contained within the BOX (51991-634-83)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		11/01/2009	04/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Groupe Parima		252437850	MANUFACTURE

Revised: 12/2010Breckenridge Pharmaceutical, Inc.

More BPS Gel resources

• BPS Gel Side Effects (in more detail)
• BPS Gel Use in Pregnancy & Breastfeeding
• BPS Gel Drug Interactions
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